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Trial record 1 of 1 for:    NCT03051217
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A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051217
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : December 11, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Moderate to Severe Psoriasis
Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Interventions Other: Placebo
Drug: Certolizumab Pegol
Enrollment 127
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
Hide 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
Arm/Group Title Placebo CZP 200 mg Q2W CZP 400 mg Q2W Total Title
Hide 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
Hide 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%
1.Primary Outcome
Title Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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.
Hide 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.
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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.
Hide 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.
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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.
Hide 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.
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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]
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
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)
Hide 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%)    
Hide 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
Hide 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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
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 18, 2020