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

• 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: UCB Biopharma S.P.R.L.
• 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

Participant Flow

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
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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.; PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.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

Baseline Characteristics

Arm/Group Title		Placebo Q2W	CZP 200 mg Q2W	CZP 400 mg Q2W	Total Title
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
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%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
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

Outcome Measure Data

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)
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

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]

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]

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]

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
Description	The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame	Week 16

Outcome Measure Data

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)
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

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]

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]

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]

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
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

Outcome Measure Data

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)
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

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]

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]

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]

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
Description	The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame	Week 48

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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)

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]

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]

Adverse Events

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)
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB
• Organization: Cares
• Phone: +1844599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Gottlieb AB, Blauvelt A, Thaci D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9.

Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

• Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
• ClinicalTrials.gov Identifier: NCT02326272
• 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