Back to resultsEfficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT)
Primary Purpose
Psoriasis, Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol
Etanercept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Certolizumab Pegol, Cimzia, Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Provided informed consent
- Adult men or women >= 18 years
- Chronic plaque psoriasis for at least 6 months
- Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3
- Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
- Erythrodermic, guttate, generalized pustular form of psoriasis
- History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
- Congestive heart failure
- History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
- Concurrent malignancy or a history of malignancy as described in the protocol
- History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
- Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
- Other protocol-defined exclusion criteria may apply
Sites / Locations
- Ps0003 317
- Ps0003 306
- Ps0003 301
- Ps0003 307
- Ps0003 405
- Ps0003 316
- Ps0003 304
- Ps0003 302
- Ps0003 313
- Ps0003 310
- Ps0003 400
- Ps0003 319
- Ps0003 404
- Ps0003 407
- Ps0003 309
- Ps0003 401
- Ps0003 403
- Ps0003 406
- Ps0003 311
- Ps0003 345
- Ps0003 343
- Ps0003 344
- Ps0003 342
- Ps0003 353
- Ps0003 351
- Ps0003 352
- Ps0003 350
- Ps0003 320
- Ps0003 325
- Ps0003 374
- Ps0003 373
- Ps0003 368
- Ps0003 378
- Ps0003 371
- Ps0003 370
- Ps0003 365
- Ps0003 363
- Ps0003 367
- Ps0003 372
- Ps0003 375
- Ps0003 369
- Ps0003 361
- Ps0003 362
- Ps0003 366
- Ps0003 381
- Ps0003 380
- Ps0003 382
- Ps0003 383
- Ps0003 384
- Ps0003 340
- Ps0003 422
- Ps0003 330
- Ps0003 335
- Ps0003 338
- Ps0003 421
- Ps0003 333
- Ps0003 334
- Ps0003 424
- Ps0003 425
- Ps0003 427
- Ps0003 423
- Ps0003 332
- Ps0003 336
- Ps0003 339
- Ps0003 390
- Ps0003 391
- Ps0003 395
- Ps0003 393
- Ps0003 394
- Ps0003 392
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
CZP 200 mg
CZP 400 mg
Etanercept
Placebo
Arm Description
Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16: Subjects with a PASI75 response at Week 16 will be re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W; with Placebo administered on alternate dosing weeks to maintain the blind) or Placebo Q2W. Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W) through Week 14. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16: Subjects with a PASI75 response at Week 16 will be re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Etanercept (ETN) subcutaneous (sc) injection 50 mg twice weekly through Week 12. The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16: Subjects with a PASI75 response at Week 16 will be re-randomized to either Certolizumab Pegol (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Placebo subcutaneous (sc) injection every two weeks (Q2W). The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16: Subjects with a PASI75 response at Week 16 continue to receive blinded Placebo. Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study. Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Outcomes
Primary Outcome Measures
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
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.
Secondary Outcome Measures
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12
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.
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
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.
Proportion of Subjects 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.
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) 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.
Proportion of Subjects 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.
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02346240
Brief Title
Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
Acronym
CIMPACT
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2015 (undefined)
Primary Completion Date
March 22, 2016 (Actual)
Study Completion Date
December 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
Detailed Description
This study consists of the following Periods:
Initial Treatment Period from Week 0 to Week 16
Maintenance Treatment Period from Week 16 to Week 48
Open-label Extension Treatment Period (96 weeks)
Safety Follow-Up (10 weeks)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Plaque Psoriasis
Keywords
Certolizumab Pegol, Cimzia, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
559 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CZP 200 mg
Arm Type
Experimental
Arm Description
Certolizumab Pegol (CZP) subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg every two weeks (Q2W) from Week 6 to Week 14.
The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects with a PASI75 response at Week 16 will be re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W; with Placebo administered on alternate dosing weeks to maintain the blind) or Placebo Q2W.
Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Arm Title
CZP 400 mg
Arm Type
Experimental
Arm Description
Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W) through Week 14.
The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects with a PASI75 response at Week 16 will be re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W.
Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Arm Title
Etanercept
Arm Type
Active Comparator
Arm Description
Etanercept (ETN) subcutaneous (sc) injection 50 mg twice weekly through Week 12.
The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects with a PASI75 response at Week 16 will be re-randomized to either Certolizumab Pegol (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W.
Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous (sc) injection every two weeks (Q2W).
The treatment received from Week 16 to Week 48 is based on initial treatment and response to treatment at Week 16:
Subjects with a PASI75 response at Week 16 continue to receive blinded Placebo.
Subjects who do not achieve a PASI75 response at Week 16 will be removed from blinded study medication and escape to CZP 400 mg Q2W. Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.
Subjects can enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
Cimzia, CDP870, CZP
Intervention Description
Active Substance: Certolizumab Pegol
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 200 mg/ mL
Route of Administration: Subcutaneous use
Intervention Type
Biological
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel, ETN
Intervention Description
Active Substance: Etanercept
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 50 mg / mL
Route of Administration: Subcutaneous use
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Active Substance: Placebo
Pharmaceutical Form: Solution for injection in pre-filled syringe
Concentration: 0.9 % saline
Route of Administration: Subcutaneous use
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
Description
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12
Description
The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame
Week 12
Title
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
Description
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 12
Title
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
Description
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 16
Title
Proportion 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
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
Title
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
Description
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 16
Title
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16
Description
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provided informed consent
Adult men or women >= 18 years
Chronic plaque psoriasis for at least 6 months
Baseline psoriasis activity and severity index >= 12 and body surface area >= 10 % and Physician's Global Assessments score >= 3
Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
Erythrodermic, guttate, generalized pustular form of psoriasis
History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
Congestive heart failure
History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
Concurrent malignancy or a history of malignancy as described in the protocol
History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug in the UK, Czech Republic, Germany, and France, and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 5 months following the last dose in France and within 10 weeks in all other countries
Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
Other protocol-defined exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0003 317
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Ps0003 306
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Ps0003 301
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Ps0003 307
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Ps0003 405
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ps0003 316
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Ps0003 304
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Ps0003 302
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Ps0003 313
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Ps0003 310
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Ps0003 400
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Ps0003 319
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044-29
Country
United States
Facility Name
Ps0003 404
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Ps0003 407
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Ps0003 309
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Ps0003 401
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Ps0003 403
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Ps0003 406
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Ps0003 311
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Ps0003 345
City
Dupnitsa
State/Province
Kyustendil
Country
Bulgaria
Facility Name
Ps0003 343
City
Sofia
State/Province
Sofia-Grad
Country
Bulgaria
Facility Name
Ps0003 344
City
Plovdiv
Country
Bulgaria
Facility Name
Ps0003 342
City
Varna
Country
Bulgaria
Facility Name
Ps0003 353
City
Pardubice
State/Province
District Of Columbia
Country
Czechia
Facility Name
Ps0003 351
City
Pardubice
Country
Czechia
Facility Name
Ps0003 352
City
Praha
Country
Czechia
Facility Name
Ps0003 350
City
Ústí nad Labem
Country
Czechia
Facility Name
Ps0003 320
City
Nice cedex 3
Country
France
Facility Name
Ps0003 325
City
Toulouse Cedex 9
Country
France
Facility Name
Ps0003 374
City
Friedrichshafen
State/Province
Baden-Wuerttemberg
Country
Germany
Facility Name
Ps0003 373
City
Muenchen
State/Province
Bayern
Country
Germany
Facility Name
Ps0003 368
City
Frankfurt am Main
State/Province
Hessen
Country
Germany
Facility Name
Ps0003 378
City
Bochum
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Ps0003 371
City
Wuppertal
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Ps0003 370
City
Mainz
State/Province
Rheinland-Pfalz
Country
Germany
Facility Name
Ps0003 365
City
Kiel
State/Province
Schleswig-Holstein
Country
Germany
Facility Name
Ps0003 363
City
Erfurt
State/Province
Thueringen
Country
Germany
Facility Name
Ps0003 367
City
Berlin
Country
Germany
Facility Name
Ps0003 372
City
Berlin
Country
Germany
Facility Name
Ps0003 375
City
Berlin
Country
Germany
Facility Name
Ps0003 369
City
Dresden
Country
Germany
Facility Name
Ps0003 361
City
Giessen
Country
Germany
Facility Name
Ps0003 362
City
Hamburg
Country
Germany
Facility Name
Ps0003 366
City
Hannover
Country
Germany
Facility Name
Ps0003 381
City
Orosháza
State/Province
Bekes
Country
Hungary
Facility Name
Ps0003 380
City
Debrecen
State/Province
Hajdú-Bihar
Country
Hungary
Facility Name
Ps0003 382
City
Budapest
Country
Hungary
Facility Name
Ps0003 383
City
Budapest
Country
Hungary
Facility Name
Ps0003 384
City
Budapest
Country
Hungary
Facility Name
Ps0003 340
City
Breda
Country
Netherlands
Facility Name
Ps0003 422
City
Wrocław
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Ps0003 330
City
Torun
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
Ps0003 335
City
Lublin
State/Province
Lubelskie
Country
Poland
Facility Name
Ps0003 338
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Ps0003 421
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Ps0003 333
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
Ps0003 334
City
Katowice
State/Province
Slaskie
Country
Poland
Facility Name
Ps0003 424
City
Poznań
State/Province
Wielkopolskie
Country
Poland
Facility Name
Ps0003 425
City
Białystok
Country
Poland
Facility Name
Ps0003 427
City
Gdańsk
Country
Poland
Facility Name
Ps0003 423
City
Gdynia
Country
Poland
Facility Name
Ps0003 332
City
Szczecin
Country
Poland
Facility Name
Ps0003 336
City
Warszawa
Country
Poland
Facility Name
Ps0003 339
City
Wrocław
Country
Poland
Facility Name
Ps0003 390
City
Dundee
State/Province
Angus
Country
United Kingdom
Facility Name
Ps0003 391
City
Hexham
State/Province
Northumberland
Country
United Kingdom
Facility Name
Ps0003 395
City
Cardiff
State/Province
Wales
Country
United Kingdom
Facility Name
Ps0003 393
City
Edgbaston
Country
United Kingdom
Facility Name
Ps0003 394
City
Liverpool
Country
United Kingdom
Facility Name
Ps0003 392
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29660425
Citation
Lebwohl M, Blauvelt A, Paul C, Sofen H, Weglowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.
Results Reference
result
PubMed Identifier
34192387
Citation
Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17.
Results Reference
result
PubMed Identifier
32531798
Citation
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
Related Info
Learn more about this trial
Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
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