Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
CIMPACT
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
2 other identifiers
interventional
559
9 countries
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2015
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2016
CompletedResults Posted
Study results publicly available
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2018
CompletedJuly 16, 2021
July 1, 2021
1.1 years
January 20, 2015
June 22, 2018
July 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 12
Secondary Outcomes (6)
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
Week 12
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
Week 12
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
Week 16
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
Week 16
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
Week 16
- +1 more secondary outcomes
Study Arms (4)
CZP 200 mg
EXPERIMENTALCertolizumab 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.
CZP 400 mg
EXPERIMENTALCertolizumab 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
ACTIVE COMPARATOREtanercept (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
PLACEBO COMPARATORPlacebo 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.
Interventions
* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/ mL * Route of Administration: Subcutaneous use
* Active Substance: Etanercept * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 50 mg / mL * Route of Administration: Subcutaneous use
* Active Substance: Placebo * Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Ps0003 317
Mobile, Alabama, 36608, United States
Ps0003 306
Little Rock, Arkansas, 72204, United States
Ps0003 301
Beverly Hills, California, 90212, United States
Ps0003 307
Los Angeles, California, 90045, United States
Ps0003 405
San Diego, California, 92123, United States
Ps0003 316
Washington D.C., District of Columbia, 20037, United States
Ps0003 304
West Palm Beach, Florida, 33409, United States
Ps0003 302
Springfield, Illinois, 62703, United States
Ps0003 313
West Dundee, Illinois, 60118, United States
Ps0003 310
Indianapolis, Indiana, 46256, United States
Ps0003 400
Henderson, Nevada, 89052, United States
Ps0003 319
Verona, New Jersey, 07044-29, United States
Ps0003 404
Buffalo, New York, 14203, United States
Ps0003 407
Portland, Oregon, 97223, United States
Ps0003 309
Johnston, Rhode Island, 02919, United States
Ps0003 401
Dallas, Texas, 75246, United States
Ps0003 403
Houston, Texas, 77065, United States
Ps0003 406
San Antonio, Texas, 78213, United States
Ps0003 311
Webster, Texas, 77598, United States
Ps0003 345
Dupnitsa, Kyustendil, Bulgaria
Ps0003 343
Sofia, Sofia-Grad, Bulgaria
Ps0003 344
Plovdiv, Bulgaria
Ps0003 342
Varna, Bulgaria
Ps0003 353
Pardubice, District of Columbia, Czechia
Ps0003 351
Pardubice, Czechia
Ps0003 352
Prague, Czechia
Ps0003 350
Ústí nad Labem, Czechia
Ps0003 320
Nice, France
Ps0003 325
Toulouse, France
Ps0003 374
Friedrichshafen, Baden-Wurttemberg, Germany
Ps0003 373
Munich, Bavaria, Germany
Ps0003 368
Frankfurt am Main, Hesse, Germany
Ps0003 378
Bochum, North Rhine-Westphalia, Germany
Ps0003 371
Wuppertal, North Rhine-Westphalia, Germany
Ps0003 370
Mainz, Rhineland-Palatinate, Germany
Ps0003 365
Kiel, Schleswig-Holstein, Germany
Ps0003 363
Erfurt, Thuringia, Germany
Ps0003 367
Berlin, Germany
Ps0003 372
Berlin, Germany
Ps0003 375
Berlin, Germany
Ps0003 369
Dresden, Germany
Ps0003 361
Giessen, Germany
Ps0003 362
Hamburg, Germany
Ps0003 366
Hanover, Germany
Ps0003 381
Orosháza, Bekes County, Hungary
Ps0003 380
Debrecen, Hajdú-Bihar, Hungary
Ps0003 382
Budapest, Hungary
Ps0003 383
Budapest, Hungary
Ps0003 384
Budapest, Hungary
Ps0003 340
Breda, Netherlands
Ps0003 424
Poznan, Greater Poland Voivodeship, Poland
Ps0003 330
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Ps0003 422
Wroclaw, Lower Silesian Voivodeship, Poland
Ps0003 335
Lublin, Lublin Voivodeship, Poland
Ps0003 338
Warsaw, Masovian Voivodeship, Poland
Ps0003 421
Warsaw, Masovian Voivodeship, Poland
Ps0003 333
Bialystok, Podlaskie Voivodeship, Poland
Ps0003 334
Katowice, Silesian Voivodeship, Poland
Ps0003 425
Bialystok, Poland
Ps0003 427
Gdansk, Poland
Ps0003 423
Gdynia, Poland
Ps0003 332
Szczecin, Poland
Ps0003 336
Warsaw, Poland
Ps0003 339
Wroclaw, Poland
Ps0003 390
Dundee, Angus, United Kingdom
Ps0003 391
Hexham, Northumberland, United Kingdom
Ps0003 395
Cardiff, Wales, United Kingdom
Ps0003 393
Edgbaston, United Kingdom
Ps0003 394
Liverpool, United Kingdom
Ps0003 392
Manchester, United Kingdom
Related Publications (3)
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.
PMID: 29660425RESULTWarren 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.
PMID: 34192387RESULTBlauvelt 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.
PMID: 32531798DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 20, 2015
First Posted
January 26, 2015
Study Start
February 11, 2015
Primary Completion
March 22, 2016
Study Completion
December 17, 2018
Last Updated
July 16, 2021
Results First Posted
July 18, 2018
Record last verified: 2021-07