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An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (CIMPASI-1)

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: NCT02326298
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : August 13, 2018
Last Update Posted : December 11, 2018
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 234
Recruitment Details This ongoing study started to enroll participants in December 2014, from multiple sites in Europe and North America. 234 participants are included in the Randomized Set (RS) shown in the Participant Flow.
Pre-assignment Details The provided data are interim results up to Week 48.
Arm/Group Title Placebo Q2W CZP 200 mg Q2W CZP 400 mg Q2W Placebo/Placebo Q2W CZP 200 mg Q2W/CZP 200 mg Q2W Placebo/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
Hide Arm/Group Description

Placebo subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

This arm consisted of subjects 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 subjects initially randomized in the CZP 200 mg Q2W arm, who achieved PASI50 at Week 16 and continued to receive CZP 200 mg every two weeks. This arm consisted of subjects 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 every two weeks (starting at Week 22). This arm consisted of subjects initially randomized in the CZP 400 mg Q2W arm, who achieved PASI50 at Week 16 and continued to receive CZP 400 mg every two weeks. This arm consisted of subjects 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 every two weeks, for 16 weeks. Subjects who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of subjects 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 every two weeks, for 16 weeks. Subjects who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. This arm consisted of subjects 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 every two weeks, for 16 weeks. Subjects who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
Period Title: Initial Period (Week 0/Baseline - Wk 16)
Started 51 95 88 0 0 0 0 0 0 0
Completed Week 16 46 92 87 0 0 0 0 0 0 0
Finished Wk16 Started Maintenance Period 46 92 85 0 0 0 0 0 0 0
Completed 46 92 85 0 0 0 0 0 0 0
Not Completed 5 3 3 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             0             3             0             0             0             0             0             0             0
Lack of Efficacy             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             1             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             3             2             0             0             0             0             0             0             0             0
Period Title: Maintenance Period (Week 16 - Week 48)
Started 0 0 0 3 74 5 77 38 18 8
Completed 0 0 0 3 71 5 70 33 13 7
Not Completed 0 0 0 0 3 0 7 5 5 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0             3             1             1             1
Patient did not achieve PASI50 response             0             0             0             0             1             0             2             0             4             0
Patient cannot attend visits             0             0             0             0             1             0             0             0             0             0
Pregnancy             0             0             0             0             0             0             1             0             0             0
No valid reason stated by patient             0             0             0             0             0             0             0             1             0             0
Lost to Follow-up             0             0             0             0             0             0             1             2             0             0
Adverse Event             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 subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

[Not Specified]
Overall Number of Baseline Participants 51 95 88 234
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Randomized Set consisting of all subjects randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 95 participants 88 participants 234 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
  88.2%
90
  94.7%
86
  97.7%
221
  94.4%
>=65 years
6
  11.8%
5
   5.3%
2
   2.3%
13
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 95 participants 88 participants 234 participants
47.9  (12.8) 44.5  (13.1) 43.6  (12.1) 44.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 95 participants 88 participants 234 participants
Female
16
  31.4%
28
  29.5%
28
  31.8%
72
  30.8%
Male
35
  68.6%
67
  70.5%
60
  68.2%
162
  69.2%
1.Primary Outcome
Title Proportion of Subjects 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 At Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects 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 subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 51 95 88
Measure Type: Number
Unit of Measure: percentage of participants
6.5 66.5 75.8
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 is evaluated at a 2-sided significance level of 0.025 for each CZP dose versus(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 28.962
Confidence Interval (2-Sided) 97.5%
6.968 to 120.371
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 for the primary analysis is 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 45.660
Confidence Interval (2-Sided) 97.5%
10.657 to 195.634
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 60.0
Confidence Interval (2-Sided) 95%
47.92 to 72.17
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 69.3
Confidence Interval (2-Sided) 95%
57.65 to 80.99
Estimation Comments [Not Specified]
2.Primary Outcome
Title Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
Time Frame At Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects 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 subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 51 95 88
Measure Type: Number
Unit of Measure: percentage of participants
4.2 47.0 57.9
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 is 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 20.116
Confidence Interval (2-Sided) 97.5%
3.699 to 109.399
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 for the primary analysis is 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 31.143
Confidence Interval (2-Sided) 97.5%
5.687 to 170.548
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 42.8
Confidence Interval (2-Sided) 95%
30.70 to 54.86
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 53.6
Confidence Interval (2-Sided) 95%
41.33 to 65.94
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects 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 At Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects 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 subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 51 95 88
Measure Type: Number
Unit of Measure: percentage of participants
0.4 35.8 43.6
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 this analysis as used in the fixed sequence testing procedure is 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 36.668
Confidence Interval (2-Sided) 97.5%
5.717 to 235.193
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 [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 Odds Ratio (OR)
Estimated Value 50.606
Confidence Interval (2-Sided) 97.5%
7.880 to 324.988
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 35.4
Confidence Interval (2-Sided) 95%
20.85 to 49.87
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 43.1
Confidence Interval (2-Sided) 95%
27.56 to 58.71
Estimation Comments [Not Specified]
4.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 of 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 At Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.
Arm/Group Title Placebo Q2W (RS) CZP 200 mg Q2W (RS) CZP 400 mg Q2W (RS)
Hide Arm/Group Description:

Placebo subcutaneous (sc) injection every two weeks (Q2W).

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

  • PASI50 responders at Week 16, who do not achieve a PASI75 response at Week 16 receive 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 continue to receive Placebo.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 51 95 88
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-3.3  (0.80) -9.3  (0.58) -10.2  (0.60)
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 P-value 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 -6.00
Confidence Interval (2-Sided) 97.5%
-8.18 to -3.81
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 P-value 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 Ajusted Mean Treatment Differences
Estimated Value -6.84
Confidence Interval (2-Sided) 97.5%
-9.05 to -4.62
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48
Time Frame At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects 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 every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 95 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.7
(41.99 to 63.32)
69.5
(59.24 to 79.77)
6.Secondary Outcome
Title Proportion of Subjects 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 At Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The Randomized Set included all subjects 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 every two weeks (Q2W) from Week 6 to Week 14.

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

  • PASI50 responders at Week 16 continue to receive CZP 200 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W.

Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study.

CZP 400 mg every two weeks (Q2W).

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

  • PASI50 responders at Week 16 continue to receive CZP 400 mg Q2W.
  • PASI50 non-responders at Week 16 will be removed from blinded study medication and escape to unblinded CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
  • PASI50 non-responders at Week 32 or a later time point will be withdrawn from the study.

Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W.

Subjects who achieve a PASI75 response during the OLE Period may switch to CZP 200 mg Q2W.

Overall Number of Participants Analyzed 95 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.2
(57.09 to 77.39)
87.1
(79.81 to 94.45)
Time Frame Adverse Events (AEs) were collected from Baseline (Week 0) until Week 48.
Adverse Event Reporting Description As per study design, most of the subjects randomized to placebo (PBO) at Week 0 either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16. Thus, the PBO arm had lower exposure compared to the CZP arms. The exposure imbalance across treatment arms could lead to misinterpretation & questionable conclusions comparing simple counts & percentages of AEs. Thus, AEs reported while subjects were on PBO treatment 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 subjects who received CZP 200 mg at any time during the study. This arm consisted of all subjects 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   0/100 (0.00%)      1/144 (0.69%)    
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   4/100 (4.00%)      11/144 (7.64%)    
Blood and lymphatic system disorders     
Lymphadenitis * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Splenic haematoma * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal necrosis * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
General disorders     
Strangulated hernia * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Injection site reaction * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Immune system disorders     
Anaphylactoid reaction * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Infections and infestations     
Erysipelas * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Injury, poisoning and procedural complications     
Concussion * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Hand fracture * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Radius fracture * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Tendon rupture * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Multiple injuries * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Rib fracture * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Osteoarthritis * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
Psychiatric disorders     
Hallucination * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Haemothorax * 1  1/100 (1.00%)  1 0/144 (0.00%)  0
Skin and subcutaneous tissue disorders     
Psoriasis * 1  0/100 (0.00%)  0 1/144 (0.69%)  1
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   44/100 (44.00%)      55/144 (38.19%)    
Infections and infestations     
Nasopharyngitis * 1  28/100 (28.00%)  37 40/144 (27.78%)  72
Upper respiratory tract infection * 1  12/100 (12.00%)  13 13/144 (9.03%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/100 (6.00%)  7 2/144 (1.39%)  2
Nervous system disorders     
Headache * 1  6/100 (6.00%)  7 12/144 (8.33%)  36
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: +1877 822 ext 9493
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT02326298     History of Changes
Other Study ID Numbers: PS0005
2014-003513-28 ( 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: December 11, 2018