Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003486-14 | EudraCT Number |
Not provided
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The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis.
This study consists of the following Periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CZP 200 mg | Experimental | CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment:
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, subjects may switch to CZP 400 mg Q2W or withdraw from the study. |
|
| CZP 400 mg | Experimental | CZP 400 mg every two weeks (Q2W) through Week 14. Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. Subjects who achieve a PASI75 response during the OLE Phase may switch to CZP 200 mg Q2W. |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab Pegol | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. | Week 16 |
| Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ps0002 203 | Phoenix | Arizona | 85032 | United States | ||
| Ps0002 214 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29660421 | Result | Gottlieb AB, Blauvelt A, Thaci D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13. | |
| 36509889 |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152.
Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set.
The study started to enroll patients in December 2014 and concluded in September 2018 from multiple sites in Europe and North America. 227 participants were included in the Randomized Set (RS) shown in the Participant Flow.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Q2W | Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Period (Week 0 to Week 16) |
|
Not provided
Not provided
Not provided
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Placebo subcutaneous (sc) injection every two weeks (Q2W). Treatment received from Week 16 - 48 is based on initial treatment and response to treatment:
Subjects who complete the Maintenance Period (with PASI50 response at Week 48) enter the Open-label Extension Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continue to receive CZP 400 mg Q2W or may switch to CZP 200 mg Q2W. |
|
|
| Placebo | Other |
|
|
|
| Week 16 |
| Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48 | 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. | Week 48 |
| Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. | Week 48 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL). | Week 16 |
| Bakersfield |
| California |
| 93309 |
| United States |
| Ps0002 212 | Santa Monica | California | 90404 | United States |
| Ps0002 204 | Ormond Beach | Florida | 32174 | United States |
| Ps0002 207 | Portsmouth | New Hampshire | 03801 | United States |
| Ps0002 202 | East Windsor | New Jersey | 08520 | United States |
| Ps0002 210 | New York | New York | 10025 | United States |
| Ps0002 206 | Rochester | New York | 14623 | United States |
| Ps0002 209 | Wilmington | North Carolina | 28405 | United States |
| Ps0002 205 | Cleveland | Ohio | 44106 | United States |
| Ps0002 200 | Portland | Oregon | 97223 | United States |
| Ps0002 201 | Greer | South Carolina | 29650 | United States |
| Ps0002 208 | San Antonio | Texas | 78213 | United States |
| Ps0002 213 | Richmond | Virginia | 23294 | United States |
| Ps0002 253 | Graz | Styria | Austria |
| Ps0002 221 | Barrie | Ontario | Canada |
| Ps0002 223 | London | Ontario | Canada |
| Ps0002 222 | Peterborough | Ontario | Canada |
| Ps0002 220 | Richmond Hill | Ontario | Canada |
| Ps0002 224 | Waterloo | Ontario | Canada |
| Ps0002 232 | Krakow | Lesser Poland Voivodeship | Poland |
| Ps0002 231 | Wroclaw | Poland |
| Ps0002 230 | Kielce | Świętokrzyskie Voivodeship | Poland |
| Derived |
| Gisondi P, Gottlieb AB, Elewski B, Augustin M, McBride S, Tsai TF, de la Loge C, Fierens F, Lopez Pinto JM, Tilt N, Lebwohl M. Long-Term Health-Related Quality of Life in Patients with Plaque Psoriasis Treated with Certolizumab Pegol: Three-Year Results from Two Randomised Phase 3 Studies (CIMPASI-1 and CIMPASI-2). Dermatol Ther (Heidelb). 2023 Jan;13(1):315-328. doi: 10.1007/s13555-022-00861-4. Epub 2022 Dec 13. |
| 32652544 | Derived | Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9. |
| 32531798 | Derived | Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6. |
| FG001 | CZP 200 mg Q2W | CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. |
| FG002 | CZP 400 mg Q2W | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. |
| FG003 | Placebo/Placebo Q2W | This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48). |
| FG004 | Placebo/CZP 200 mg Q2W | This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22). |
| FG005 | CZP 200 mg Q2W/CZP 200 mg Q2W | This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W. |
| FG006 | CZP 400 mg Q2W/CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W. |
| FG007 | Placebo/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG008 | CZP 200 mg Q2W/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG009 | CZP 400 mg Q2W/Escape CZP 400 mg Q2W | This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study. |
| FG010 | Placebo/CZP 200 mg Q2W OLE | This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W. |
| FG011 | CZP 200 mg Q2W/CZP 200 mg Q2W OLE | This arm consisted of participants who received CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE. |
| FG012 | CZP 400 mg Q2W/CZP 200 mg Q2W OLE | This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose. |
| FG013 | CZP 400 mg Q2W/CZP 400 mg Q2W OLE | This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose. |
| FG014 | Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE | This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE. |
| Completed Week 16 |
|
| Finished Wk16 Entered Maintenance Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (Week 16 to Week 48) |
|
|
| Open-label Period (Week 48 to Week 144) |
|
|
Baseline Characteristics refer to the Randomized Set, which consisted of all participants randomized into the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Q2W | Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. |
| BG001 | CZP 200 mg Q2W | CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. |
| BG002 | CZP 400 mg Q2W | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 | 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. | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16 | The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48 | 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. | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 | The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL). | The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 16 |
|
Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the participants were on PBO are not included in this summary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CZP 200 mg Q2W (TCS) | This arm consisted of all participants who received CZP 200 mg at any time during the study. | 1 | 170 | 24 | 170 | 76 | 170 |
| EG001 | CZP 400 mg Q2W (TCS) | This arm consisted of all participants who received CZP 400 mg at any time during the study. | 1 | 149 | 12 | 149 | 75 | 149 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Tolosa-Hunt syndrome | Eye disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Haemorrhagic necrotic pancreatitis | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pharyngo-oesophageal diverticulum | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Ovarian abscess | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Infected bite | Immune system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Blood count abnormal | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA18.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pregnancy with contraceptive device | Pregnancy, puerperium and perinatal conditions | MedDRA18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Penile swelling | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Scrotal swelling | Reproductive system and breast disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Laryngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Tonsillar cyst | Respiratory, thoracic and mediastinal disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA18.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA18.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Subject moved out of state |
|
| Pregnancy |
|
| Non-compliance |
|
| Did not achieve PASI50 |
|
| Adverse event after completing wk48 |
|
| Did not achieve PASI50 after wk48 |
|
| Adverse Event |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Did not achieve PASI50 |
|
| Loss of efficacy |
|
| Pregnancy |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | Estimated difference in responder rate | 69.7 | 2-Sided | 95 | 57.12 | 82.36 | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | <0.0001 | The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO. | Odds Ratio (OR) | 36.212 | 2-Sided | 97.5 | 10.686 | 122.713 | Superiority |
| The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure. | Regression, Logistic | Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure. | Estimated difference in responder rate | 71.0 | 2-Sided | 95 | 58.47 | 83.43 | Superiority |
| CZP 200 mg Q2W (RS) |
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS. |
| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS. |
|
|
|
| OG001 | CZP 200 mg Q2W (RS) | CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS. |
| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS. |
|
|
|
| OG001 |
| CZP 400 mg Q2W (RS) |
CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS. |
|
|
| OG001 | CZP 400 mg Q2W (RS) | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS. |
|
|
| OG001 | CZP 200 mg Q2W (RS) | CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS. |
| OG002 | CZP 400 mg Q2W (RS) | CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS. |
|
|
|