A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

• ClinicalTrials.gov Identifier: NCT03051217
• Recruitment Status: Completed
• First Posted: February 13, 2017
• Results First Posted: December 11, 2019
• Last Update Posted: January 4, 2022
• 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: Moderate to Severe Psoriasis; Generalized Pustular Psoriasis and Erythrodermic Psoriasis
• Interventions: Other: Placebo; Drug: Certolizumab Pegol
• Enrollment: 127

Participant Flow

Recruitment Details	The study started to enroll patients in February 2017 and concluded in January 2019.
Pre-assignment Details	The study included a 5 Week Screening Period, an Initial Period up to Week 16, a Maintenance Period up to Week 52 and a Safety Follow-up Period up to Week 60. Participant Flow refers to the Randomized Set (RS)

Arm/Group Title	Placebo	CZP 200 mg Q2W	CZP 400 mg Q2W	Placebo/Placebo	CZP 400 mg Q2W/CZP 400 mg Q2W	CZP 200 mg Q2W/CZP 200 mg Q2W	CZP 200 mg Q2W/CZP 400 mg Q4W
Arm/Group Description	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.	This arm consisted of participants who were initially randomized to Placebo during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive Placebo during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.	This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.	This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.	This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W.
Period Title: Initial Period (Week 0 to Week 16)
Started	26	48	53	0	0	0	0
Completed	23	46	51	0	0	0	0
Not Completed	3	2	2	0	0	0	0
Reason Not Completed
Adverse Event	2	0	1	0	0	0	0
Protocol Violation	0	1	0	0	0	0	0
Withdrawal by Subject	1	1	1	0	0	0	0
Period Title: Maintenance Period (Week 16 to Week 52)
Started	0	0	0	23	51	26	20
Received Escape Treatment	0	0	0	21	3	7	3
Completed	0	0	0	20	48	24	19
Not Completed	0	0	0	3	3	2	1
Reason Not Completed
Adverse Event	0	0	0	1	2	1	1
Lack of Efficacy	0	0	0	1	0	0	0
Protocol Violation	0	0	0	1	0	0	0
Withdrawal by Subject	0	0	0	0	1	0	0
Difficulty in going to hospital	0	0	0	0	0	1	0

Baseline Characteristics

Arm/Group Title		Placebo	CZP 200 mg Q2W	CZP 400 mg Q2W	Total Title
Arm/Group Description		This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period.	[Not Specified]
Overall Number of Baseline Participants		26	48	53	127
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set which consisted of all participants in the Randomized Set (RS) who received at least 1 dose of study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	48 participants	53 participants	127 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	24 92.3%	40 83.3%	49 92.5%	113 89.0%
	>=65 years	2 7.7%	8 16.7%	4 7.5%	14 11.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	26 participants	48 participants	53 participants	127 participants
		47.93 (11.37)	48.43 (13.47)	52.43 (11.59)	50.00 (12.37)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	48 participants	53 participants	127 participants
	Female	5 19.2%	12 25.0%	11 20.8%	28 22.0%
	Male	21 80.8%	36 75.0%	42 79.2%	99 78.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	48 participants	53 participants	127 participants
	Asian (Japanese only)	26 100.0%	48 100.0%	53 100.0%	127 100.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
Description	The PASI75 response assessments were 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 Full Analysis Set (FAS) consisted of all participants in the Randomized Set (RS) who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title	Placebo (FAS)	CZP 200 mg Q2W (FAS)	CZP 400 mg Q2W (FAS)
Arm/Group Description:	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
Overall Number of Participants Analyzed	26	48	53
Measure Type: Number; Unit of Measure: percentage of participants
	7.9	73.0	87.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	65.1
	Confidence Interval	(2-Sided) 95%; 48.22 to 81.90
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	79.1
	Confidence Interval	(2-Sided) 95%; 65.10 to 93.17
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	31.695
	Confidence Interval	(2-Sided) 97.5%; 5.129 to 195.877
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	79.112
	Confidence Interval	(2-Sided) 97.5%; 11.739 to 533.168
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16
Description	This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). 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 Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title	Placebo (FAS)	CZP 200 mg Q2W (FAS)	CZP 400 mg Q2W (FAS)
Arm/Group Description:	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
Overall Number of Participants Analyzed	26	48	53
Measure Type: Number; Unit of Measure: percentage of participants
	0.0	52.7	66.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	52.7
	Confidence Interval	(2-Sided) 95%; 29.95 to 75.39
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	66.7
	Confidence Interval	(2-Sided) 95%; 43.34 to 90.15
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	38.193
	Confidence Interval	(2-Sided) 97.5%; 6.113 to 238.619
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	69.580
	Confidence Interval	(2-Sided) 97.5%; 11.138 to 434.659
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
Description	The PASI90 response assessments were 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 Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.

Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Arm/Group Title	Placebo (FAS)	CZP 200 mg Q2W (FAS)	CZP 400 mg Q2W (FAS)
Arm/Group Description:	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
Overall Number of Participants Analyzed	26	48	53
Measure Type: Number; Unit of Measure: percentage of participants
	0.2	53.8	75.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	53.6
	Confidence Interval	(2-Sided) 95%; 30.67 to 76.47
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Estimated difference in responder rate
	Estimated Value	75.5
	Confidence Interval	(2-Sided) 95%; 51.95 to 99.04
	Estimation Comments	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	38.696
	Confidence Interval	(2-Sided) 97.5%; 6.047 to 247.634
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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	If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	100.459
	Confidence Interval	(2-Sided) 97.5%; 15.540 to 649.437
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Description	This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The DLQI is a subject-reported questionnaire designed for use in adult participants 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 asked participants 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	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.

Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.

Arm/Group Title	Placebo (FAS)	CZP 200 mg Q2W (FAS)	CZP 400 mg Q2W (FAS)
Arm/Group Description:	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
Overall Number of Participants Analyzed	26	48	53
Least Squares Mean (Standard Error); Unit of Measure: Scores on a scale
	-0.3 (1.0)	-6.8 (0.7)	-6.8 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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 and prior biologic exposure as factors and Baseline DLQI score as a covariate.
Method of Estimation	Estimation Parameter	Adjusted Mean Treatment Difference
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 97.5%; -9.100 to -3.844
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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 and prior biologic exposure as factors and Baseline DLQI score as a covariate.
Method of Estimation	Estimation Parameter	Adjusted Mean Treatment Difference
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 97.5%; -9.099 to -3.910
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline in Itch Numeric Rating Scale at Week 16
Description	This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing "no itching" and 10, representing "worst itch imaginable" (Kimball et al, 2016).
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.

Missing data were handled using the last observation carried forward (LOCF) method for the Itch Numeric Rating Scale.

Arm/Group Title	Placebo (FAS)	CZP 200 mg Q2W (FAS)	CZP 400 mg Q2W (FAS)
Arm/Group Description:	This arm consisted of participants who received Placebo subcutaneous (sc) injection every two weeks (Q2W) during the Initial Period. Participants formed the Full Analysis Set (FAS).	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) starting at Week 6 during the Initial Period. Participants formed the FAS.	This arm consisted of participants who received Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the Initial Period. Participants formed the FAS.
Overall Number of Participants Analyzed	26	48	53
Least Squares Mean (Standard Error); Unit of Measure: Scores on a scale
	0.2 (0.5)	-2.9 (0.4)	-4.0 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 200 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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 Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.
Method of Estimation	Estimation Parameter	Adjusted Mean Treatment Difference
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -4.265 to -2.002
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo (FAS), CZP 400 mg Q2W (FAS)
	Comments	The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.
	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 Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.
Method of Estimation	Estimation Parameter	Adjusted Mean Treatment Difference
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -5.295 to -3.069
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Plasma Concentration of Certolizumab Pegol (CZP)
Description	Plasma concentration was expressed in micrograms per milliliter (μg/mL). Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries. The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ.
Time Frame	Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.

Arm/Group Title		CZP 200 mg Q2W/CZP 200 mg Q2W (PK-PPS)	CZP 400 mg Q2W/CZP 400 mg Q2W (PK-PPS)	CZP 200 mg Q2W/CZP 400 mg Q4W (PK-PPS)
Arm/Group Description:		This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.	This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.
Overall Number of Participants Analyzed		28	53	20
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: µg/mL
Baseline	Number Analyzed	28 participants	53 participants	20 participants
		NA [1]; (NA%)	NA [1]; (NA%)	NA [1]; (NA%)
Week 2	Number Analyzed	28 participants	53 participants	20 participants
		34.6417; (28.3%)	35.2588; (25.2%)	33.2026; (26.0%)
Week 4	Number Analyzed	28 participants	52 participants	20 participants
		47.9241; (45.6%)	47.0462; (35.7%)	48.3634; (21.3%)
Week 6	Number Analyzed	28 participants	52 participants	20 participants
		36.3003; (286.7%)	41.2410; (183.0%)	52.4876; (38.0%)
Week 8	Number Analyzed	28 participants	52 participants	20 participants
		21.9292; (621.4%)	39.9282; (243.7%)	33.4139; (69.0%)
Week 12	Number Analyzed	26 participants	50 participants	20 participants
		16.1907; (300.7%)	46.9934; (189.3%)	23.8437; (105.9%)
Week 16	Number Analyzed	26 participants	51 participants	20 participants
		14.5995; (405.5%)	48.3156; (183.8%)	18.1204; (381.8%)
Week 24	Number Analyzed	21 participants	49 participants	20 participants
		26.2596; (52.8%)	51.6911; (118.2%)	7.7206; (1747.5%)
Week 32	Number Analyzed	20 participants	49 participants	19 participants
		26.9398; (48.8%)	44.5749; (177.2%)	8.4148; (1245.6%)
Week 40	Number Analyzed	19 participants	48 participants	17 participants
		22.2790; (68.3%)	50.9685; (53.3%)	16.7013; (231.1%)
Week 52	Number Analyzed	19 participants	45 participants	17 participants
		20.4541; (90.8%)	54.1341; (43.4%)	15.9290; (149.1%)
Early Withdrawal	Number Analyzed	4 participants	6 participants	0 participants
		0.8342; (5520.7%)	0.6115; (49802.8%)
Safety Follow-Up	Number Analyzed	27 participants	53 participants	20 participants
		0.1739; (757.5%)	0.3760; (1460.3%)	0.1407; (714.5%)

[1]

Values were below the level of detection.

7. Secondary Outcome

Title	Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma
Description	A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline. A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (>=) 1.67-fold increase from Baseline on CZP treatment.
Time Frame	Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

Outcome Measure Data

Analysis Population Description

The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.

Arm/Group Title	CZP 200 mg Q2W/CZP 200 mg Q2W (PK-PPS)	CZP 400 mg Q2W/CZP 400 mg Q2W (PK-PPS)	CZP 200 mg Q2W/CZP 400 mg Q4W (PK-PPS)
Arm/Group Description:	This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 200 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	This arm consisted of participants who were initially randomized to CZP 400 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.	This arm consisted of participants who were initially randomized to CZP 200 mg Q2W during the Initial Period, who achieved a PASI50 response at Week 16 and were re-randomized to receive CZP 400 mg Q4W, with Placebo administered on alternate dosing weeks to maintain the blind, during the Maintenance Period. Participants who did not achieve a PASI50 response at Week 16 escaped from the double-blind treatment and received open-label CZP 400 mg Q2W as 3 loading doses followed by CZP 200 mg Q2W. Participants formed the PK-PPS.
Overall Number of Participants Analyzed	28	53	20
Measure Type: Number; Unit of Measure: percentage of participants
	100	96.2	90.0

Adverse Events

Time Frame

Adverse Events (AEs) were collected from Baseline (Week 0) until the Safety Follow-up Visit (Week 60).

Adverse Event Reporting Description

Until Week 16 (Initial Period), there were 26 pts of PBO, 48 pts of CZP 200 mg, 53 pts of CZP 400 mg, but the safety set up to Week 52 was Escape Arm after Week 16, and CZP was administered. Therefore, Combined Initial and Maintenance Period is evaluated by the number of pts actually administered according to the dose of CZP.

Arm/Group Title

Placebo (SS)

CZP 200mg Q2W (SS)

CZP 400mg Q4W (SS)

CZP 200 mg Q2W + CZP 400 mg Q4W (SS)

CZP 400 mg Q2W (SS)

All CZP (SS)

Arm/Group Description

This arm consisted of participants who received at least one dose of Placebo subcutaneous (sc) injection every two weeks (Q2W) during the study. Participants formed the Safety Set (SS).

This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) during the study. Participants formed the SS.

This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.

This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 200 mg every two weeks (Q2W) and at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every four weeks (Q4W) during the study. Participants formed the SS.

This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg every two weeks (Q2W) during the study. Participants formed the SS.

This arm consisted of participants who received at least one dose of Certolizumab Pegol (CZP) subcutaneous (sc) injection regardless of the dose during the study. Participants formed the SS.

All-Cause Mortality

Placebo (SS)

CZP 200mg Q2W (SS)

CZP 400mg Q4W (SS)

CZP 200 mg Q2W + CZP 400 mg Q4W (SS)

CZP 400 mg Q2W (SS)

All CZP (SS)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/26 (0.00%)

0/72 (0.00%)

0/20 (0.00%)

0/72 (0.00%)

0/64 (0.00%)

0/122 (0.00%)

Serious Adverse Events

Placebo (SS)

CZP 200mg Q2W (SS)

CZP 400mg Q4W (SS)

CZP 200 mg Q2W + CZP 400 mg Q4W (SS)

CZP 400 mg Q2W (SS)

All CZP (SS)

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

1/26 (3.85%)

2/72 (2.78%)

0/20 (0.00%)

2/72 (2.78%)

6/64 (9.38%)

8/122 (6.56%)

Blood and lymphatic system disorders

Neutropenia * 1

0/26 (0.00%)

0

1/72 (1.39%)

1

0/20 (0.00%)

0

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Thrombocytopenia * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

1/64 (1.56%)

1

1/122 (0.82%)

1

Eye disorders

Eyelid ptosis * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

1/64 (1.56%)

1

1/122 (0.82%)

1

Gastrointestinal disorders

Large intestine polyp * 1

1/26 (3.85%)

1

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

1/64 (1.56%)

1

1/122 (0.82%)

1

Dental cyst * 1

1/26 (3.85%)

1

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

0/64 (0.00%)

0

0/122 (0.00%)

0

Immune system disorders

Sarcoidosis * 1

0/26 (0.00%)

0

1/72 (1.39%)

1

0/20 (0.00%)

0

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Infections and infestations

Herpes zoster * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

1/64 (1.56%)

1

1/122 (0.82%)

1

Latent tuberculosis * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

2/64 (3.13%)

2

2/122 (1.64%)

2

Skin and subcutaneous tissue disorders

Henoch-Schonlein purpura * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

1/64 (1.56%)

1

1/122 (0.82%)

1

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%

Placebo (SS)

CZP 200mg Q2W (SS)

CZP 400mg Q4W (SS)

CZP 200 mg Q2W + CZP 400 mg Q4W (SS)

CZP 400 mg Q2W (SS)

All CZP (SS)

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

17/26 (65.38%)

41/72 (56.94%)

15/20 (75.00%)

48/72 (66.67%)

45/64 (70.31%)

91/122 (74.59%)

Cardiac disorders

Aortic valve incompetence * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Arrhythmia * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Gastrointestinal disorders

Dental caries * 1

0/26 (0.00%)

0

2/72 (2.78%)

2

2/20 (10.00%)

2

4/72 (5.56%)

4

1/64 (1.56%)

1

5/122 (4.10%)

5

Abdominal pain upper * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Constipation * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Abdominal discomfort * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Infections and infestations

Gastroenteritis * 1

0/26 (0.00%)

0

2/72 (2.78%)

2

1/20 (5.00%)

1

3/72 (4.17%)

3

1/64 (1.56%)

1

4/122 (3.28%)

4

Folliculitis * 1

0/26 (0.00%)

0

2/72 (2.78%)

2

1/20 (5.00%)

1

3/72 (4.17%)

3

3/64 (4.69%)

4

6/122 (4.92%)

7

Myringitis * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Influenza * 1

3/26 (11.54%)

4

1/72 (1.39%)

1

1/20 (5.00%)

1

2/72 (2.78%)

2

2/64 (3.13%)

2

4/122 (3.28%)

4

Dermatophytosis of nail * 1

0/26 (0.00%)

0

1/72 (1.39%)

1

0/20 (0.00%)

0

1/72 (1.39%)

1

4/64 (6.25%)

4

5/122 (4.10%)

5

Body tinea * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Tinea versicolour * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Nasopharyngitis * 1

6/26 (23.08%)

8

23/72 (31.94%)

24

6/20 (30.00%)

6

25/72 (34.72%)

30

28/64 (43.75%)

48

53/122 (43.44%)

78

Injury, poisoning and procedural complications

Meniscus injury * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Ligament sprain * 1

2/26 (7.69%)

2

0/72 (0.00%)

0

0/20 (0.00%)

0

0/72 (0.00%)

0

0/64 (0.00%)

0

0/122 (0.00%)

0

Limb injury * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Investigations

Cell marker increased * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

1/64 (1.56%)

1

2/122 (1.64%)

2

Metabolism and nutrition disorders

Type 2 diabetes mellitus * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Musculoskeletal and connective tissue disorders

Arthritis * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Temporomandibular joint syndrome * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Back pain * 1

0/26 (0.00%)

0

2/72 (2.78%)

3

2/20 (10.00%)

2

4/72 (5.56%)

5

3/64 (4.69%)

4

7/122 (5.74%)

9

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Skin papilloma * 1

2/26 (7.69%)

2

1/72 (1.39%)

1

0/20 (0.00%)

0

1/72 (1.39%)

1

1/64 (1.56%)

1

2/122 (1.64%)

2

Nervous system disorders

Headache * 1

0/26 (0.00%)

0

2/72 (2.78%)

2

2/20 (10.00%)

2

4/72 (5.56%)

4

4/64 (6.25%)

6

7/122 (5.74%)

10

Dizziness * 1

0/26 (0.00%)

0

2/72 (2.78%)

2

1/20 (5.00%)

1

3/72 (4.17%)

3

0/64 (0.00%)

0

3/122 (2.46%)

3

Psychiatric disorders

Insomnia * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

1/64 (1.56%)

1

2/122 (1.64%)

2

Respiratory, thoracic and mediastinal disorders

Cough * 1

4/26 (15.38%)

4

4/72 (5.56%)

5

0/20 (0.00%)

0

4/72 (5.56%)

5

3/64 (4.69%)

4

7/122 (5.74%)

9

Sputum increased * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Skin and subcutaneous tissue disorders

Eczema * 1

0/26 (0.00%)

0

5/72 (6.94%)

7

0/20 (0.00%)

0

5/72 (6.94%)

7

4/64 (6.25%)

4

9/122 (7.38%)

11

Dermatitis contact * 1

0/26 (0.00%)

0

1/72 (1.39%)

1

1/20 (5.00%)

1

2/72 (2.78%)

2

4/64 (6.25%)

4

6/122 (4.92%)

6

Dyshidrotic eczema * 1

0/26 (0.00%)

0

1/72 (1.39%)

1

1/20 (5.00%)

1

2/72 (2.78%)

2

2/64 (3.13%)

2

4/122 (3.28%)

4

Pruritus * 1

2/26 (7.69%)

2

2/72 (2.78%)

3

0/20 (0.00%)

0

2/72 (2.78%)

3

1/64 (1.56%)

1

3/122 (2.46%)

4

Psoriasis * 1

6/26 (23.08%)

6

8/72 (11.11%)

8

0/20 (0.00%)

0

8/72 (11.11%)

8

5/64 (7.81%)

5

13/122 (10.66%)

13

Vascular disorders

Essential hypertension * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

Orthostatic hypotension * 1

0/26 (0.00%)

0

0/72 (0.00%)

0

1/20 (5.00%)

1

1/72 (1.39%)

1

0/64 (0.00%)

0

1/122 (0.82%)

1

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: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Imafuku S, Tada Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. Dermatol Ther (Heidelb). 2022 Jan;12(1):121-135. doi: 10.1007/s13555-021-00645-2. Epub 2021 Nov 26.

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

Okubo Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2022 Jun;12(6):1397-1415. doi: 10.1007/s13555-022-00741-x. Epub 2022 May 27.

Umezawa Y, Asahina A, Imafuku S, Tada Y, Sano S, Morita A, Sakurai S, Hoshii N, Tilt N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2021 Jun;11(3):943-960. doi: 10.1007/s13555-021-00520-0. Epub 2021 Apr 22.

Umezawa Y, Sakurai S, Hoshii N, Nakagawa H; PS0017 Study Group. Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):513-528. doi: 10.1007/s13555-021-00494-z. Epub 2021 Feb 19.

• Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
• ClinicalTrials.gov Identifier: NCT03051217
• Other Study ID Numbers: PS0017
• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Results First Submitted: November 19, 2019
• Results First Posted: December 11, 2019
• Last Update Posted: January 4, 2022