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A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (CIMPASI-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02326272
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : August 13, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Psoriasis
Plaque Psoriasis
Interventions Biological: Certolizumab Pegol
Other: Placebo
Enrollment 227
Recruitment Details The study started to enroll patients in December 2014 and concluded in September 2018 from multiple sites in Europe and North America. 227 participants were included in the Randomized Set (RS) shown in the Participant Flow.
Pre-assignment Details

The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152.

Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set.

Arm/Group Title Placebo Q2W CZP 200 mg Q2W CZP 400 mg Q2W Placebo/Placebo Q2W Placebo/CZP 200 mg Q2W CZP 200 mg Q2W/CZP 200 mg Q2W CZP 400 mg Q2W/CZP 400 mg Q2W Placebo/Escape CZP 400 mg Q2W CZP 200 mg Q2W/Escape CZP 400 mg Q2W CZP 400 mg Q2W/Escape CZP 400 mg Q2W Placebo/CZP 200 mg Q2W OLE CZP 200 mg Q2W/CZP 200 mg Q2W OLE CZP 400 mg Q2W/CZP 200 mg Q2W OLE CZP 400 mg Q2W/CZP 400 mg Q2W OLE Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
Hide Arm/Group Description

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48). This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22). This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W. This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W. This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W. This arm consisted of participants who received CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE. This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose. This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose. This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE.
Period Title: Initial Period (Week 0 to Week 16)
Started 49 91 87 0 0 0 0 0 0 0 0 0 0 0 0
Completed Week 16 45 84 83 0 0 0 0 0 0 0 0 0 0 0 0
Finished Wk16 Entered Maintenance Period 45 84 81 0 0 0 0 0 0 0 0 0 0 0 0
Completed 45 84 81 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 4 7 6 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             3             1             0             0             0             0             0             0             0             0             0             0             0             0
Lost to Follow-up             1             2             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             3             2             1             0             0             0             0             0             0             0             0             0             0             0             0
Moved from the study area             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0
Missed two doses             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0
Lost to follow-up after completing wk16             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0
Consent withdrawn after completing wk16             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0
Period Title: Maintenance Period (Week 16 to Week 48)
Started 0 0 0 6 5 76 69 34 8 12 0 0 0 0 0
Completed Week 48 0 0 0 5 3 64 61 27 3 10 0 0 0 0 0
Finished Wk48 Entered Open-label Period 0 0 0 5 3 63 60 27 3 10 0 0 0 0 0
Completed 0 0 0 5 3 63 60 27 3 10 0 0 0 0 0
Not Completed 0 0 0 1 2 13 9 7 5 2 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             2             3             4             2             1             0             0             0             0             0             0
Lack of Efficacy             0             0             0             0             0             2             1             0             1             1             0             0             0             0             0
Lost to Follow-up             0             0             0             0             0             2             0             2             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             1             0             3             1             1             0             1             0             0             0             0             0
Subject moved out of state             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0
Pregnancy             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0
Non-compliance             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Did not achieve PASI50             0             0             0             0             0             2             1             1             2             0             0             0             0             0             0
Adverse event after completing wk48             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
Did not achieve PASI50 after wk48             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0
Period Title: Open-label Period (Week 48 to Week 144)
Started 0 0 0 0 0 0 0 0 0 0 5 66 59 1 40
Completed 0 0 0 0 0 0 0 0 0 0 2 51 48 1 31
Not Completed 0 0 0 0 0 0 0 0 0 0 3 15 11 0 9
Reason Not Completed
Death             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
Adverse Event             0             0             0             0             0             0             0             0             0             0             1             8             3             0             1
Lack of Efficacy             0             0             0             0             0             0             0             0             0             0             1             0             1             0             0
Protocol Violation             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             1             0             2             0             3
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             4             0             0             2
Did not achieve PASI50             0             0             0             0             0             0             0             0             0             0             0             1             3             0             3
Loss of efficacy             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Pregnancy             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
Arm/Group Title Placebo Q2W CZP 200 mg Q2W CZP 400 mg Q2W Total Title
Hide Arm/Group Description

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

[Not Specified]
Overall Number of Baseline Participants 49 91 87 227
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Set, which consisted of all participants randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 91 participants 87 participants 227 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  93.9%
84
  92.3%
76
  87.4%
206
  90.7%
>=65 years
3
   6.1%
7
   7.7%
11
  12.6%
21
   9.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 91 participants 87 participants 227 participants
43.3  (14.5) 46.7  (13.3) 46.4  (13.5) 45.9  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 91 participants 87 participants 227 participants
Female
23
  46.9%
33
  36.3%
44
  50.6%
100
  44.1%
Male
26
  53.1%
58
  63.7%
43
  49.4%
127
  55.9%
1.Primary Outcome
Title Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants formed the Randomized Set (RS).

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 49 91 87
Measure Type: Number
Unit of Measure: percentage of participants
11.6 81.4 82.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 33.405
Confidence Interval (2-Sided) 97.5%
9.965 to 111.983
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 69.7
Confidence Interval (2-Sided) 95%
57.12 to 82.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 36.212
Confidence Interval (2-Sided) 97.5%
10.686 to 122.713
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 71.0
Confidence Interval (2-Sided) 95%
58.47 to 83.43
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants formed the Randomized Set (RS).

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 49 91 87
Measure Type: Number
Unit of Measure: percentage of participants
2.0 66.8 71.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 106.225
Confidence Interval (2-Sided) 97.5%
9.572 to 1178.843
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 64.8
Confidence Interval (2-Sided) 95%
52.16 to 77.46
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 133.163
Confidence Interval (2-Sided) 97.5%
11.904 to 1489.578
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 69.6
Confidence Interval (2-Sided) 95%
57.48 to 81.77
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
Hide Description The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants formed the Randomized Set (RS).

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 49 91 87
Measure Type: Number
Unit of Measure: percentage of participants
4.5 52.6 55.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 24.283
Confidence Interval (2-Sided) 97.5%
4.386 to 134.432
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 48.1
Confidence Interval (2-Sided) 95%
35.04 to 61.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 27.204
Confidence Interval (2-Sided) 97.5%
4.895 to 151.198
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
Method of Estimation Estimation Parameter Estimated difference in responder rate
Estimated Value 51.0
Confidence Interval (2-Sided) 95%
37.75 to 64.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 91 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.6
(61.22 to 83.92)
66.6
(54.35 to 78.86)
5.Secondary Outcome
Title Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48
Hide Description The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 91 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.7
(68.93 to 88.45)
81.3
(71.90 to 90.67)
6.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Hide Description The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients’ health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo sc injection Q2W.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
  • PASI75 responders at Week 16 continued to receive Placebo.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants formed the Randomized Set (RS).

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.

Participants formed the RS.

CZP 400 mg Q2W through Week 14.

Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:

  • PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.

Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.

Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.

Participants formed the RS.

Overall Number of Participants Analyzed 49 90 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-3.8  (0.84) -10.4  (0.62) -10.0  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 200 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.
Method ANCOVA
Comments ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.
Method of Estimation Estimation Parameter Adjusted Mean Treatment Differences
Estimated Value -6.62
Confidence Interval (2-Sided) 97.5%
-8.88 to -4.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Q2W (RS), CZP 400 mg Q2W (RS)
Comments The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.
Method ANCOVA
Comments ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.
Method of Estimation Estimation Parameter Adjusted Mean Treatment Differences
Estimated Value -6.19
Confidence Interval (2-Sided) 97.5%
-8.46 to -3.93
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Adverse Event Reporting Description As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the participants were on PBO are not included in this summary.
 
Arm/Group Title CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
Hide Arm/Group Description This arm consisted of all participants who received CZP 200 mg at any time during the study. This arm consisted of all participants who received CZP 400 mg at any time during the study.
All-Cause Mortality
CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/170 (0.59%)      1/149 (0.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/170 (14.12%)      12/149 (8.05%)    
Blood and lymphatic system disorders     
Disseminated intravascular coagulation * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Cardiac disorders     
Cardiac failure congestive * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Eye disorders     
Tolosa-Hunt syndrome * 1  0/170 (0.00%)  0 1/149 (0.67%)  2
Gastrointestinal disorders     
Haemorrhagic necrotic pancreatitis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Colitis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Pharyngo-oesophageal diverticulum * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Abdominal pain * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Rectal haemorrhage * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
General disorders     
Chest pain * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Drug-induced liver injury * 1  2/170 (1.18%)  2 0/149 (0.00%)  0
Immune system disorders     
Anaphylactic reaction * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Infected bite * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Infections and infestations     
Abdominal abscess * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Appendicitis * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Cellulitis * 1  1/170 (0.59%)  2 0/149 (0.00%)  0
Bartholin's abscess * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Ovarian abscess * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Varicella * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Pneumonia legionella * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Chronic sinusitis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Urinary tract infection * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Haematoma infection * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Injury, poisoning and procedural complications     
Contusion * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Investigations     
Blood count abnormal * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Transaminases increased * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Chest X-ray abnormal * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Musculoskeletal and connective tissue disorders     
Rotator cuff syndrome * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Psoriatic arthropathy * 1  2/170 (1.18%)  2 0/149 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign salivary gland neoplasm * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Non-small cell lung cancer * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Prostate cancer * 1  1/170 (0.59%)  1 1/149 (0.67%)  1
Basal cell carcinoma * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Nervous system disorders     
Migraine * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Multiple sclerosis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Transient ischaemic attack * 1  2/170 (1.18%)  2 0/149 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy with contraceptive device * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Psychiatric disorders     
Depression * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Penile swelling * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Genital haemorrhage * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Scrotal swelling * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Respiratory, thoracic and mediastinal disorders     
Laryngeal cyst * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Epistaxis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Atelectasis * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Pulmonary embolism * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Tonsillar cyst * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin ulcer * 1  0/170 (0.00%)  0 1/149 (0.67%)  1
Vascular disorders     
Distributive shock * 1  1/170 (0.59%)  1 0/149 (0.00%)  0
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CZP 200 mg Q2W (TCS) CZP 400 mg Q2W (TCS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/170 (44.71%)      75/149 (50.34%)    
Infections and infestations     
Nasopharyngitis * 1  33/170 (19.41%)  55 35/149 (23.49%)  45
Upper respiratory tract infection * 1  19/170 (11.18%)  20 18/149 (12.08%)  21
Sinusitis * 1  13/170 (7.65%)  15 4/149 (2.68%)  4
Pharyngitis * 1  10/170 (5.88%)  12 4/149 (2.68%)  4
Urinary tract infection * 1  11/170 (6.47%)  15 10/149 (6.71%)  14
Injury, poisoning and procedural complications     
Ligament sprain * 1  8/170 (4.71%)  8 5/149 (3.36%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/170 (3.53%)  6 8/149 (5.37%)  8
Nervous system disorders     
Headache * 1  9/170 (5.29%)  10 6/149 (4.03%)  6
Skin and subcutaneous tissue disorders     
Pruritus * 1  3/170 (1.76%)  3 8/149 (5.37%)  8
Psoriasis * 1  9/170 (5.29%)  10 12/149 (8.05%)  19
Vascular disorders     
Hypertension * 1  7/170 (4.12%)  8 9/149 (6.04%)  9
1
Term from vocabulary, MedDRA18.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02326272     History of Changes
Other Study ID Numbers: PS0002
2014-003486-14 ( EudraCT Number )
First Submitted: December 22, 2014
First Posted: December 29, 2014
Results First Submitted: June 22, 2018
Results First Posted: August 13, 2018
Last Update Posted: October 3, 2019