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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Plaque Psoriasis
• Intervention / Treatment: Other: Placebo; Biological: Certolizumab Pegol; Biological: Etanercept

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)

• Study Type: Interventional
• Enrollment (Actual): 559
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria
    • Ps0003 344
  • Varna, Bulgaria
    • Ps0003 342
  • Kyustendil
    • Dupnitsa, Kyustendil, Bulgaria
      • Ps0003 345
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria
      • Ps0003 343
• Czechia
  • Pardubice, Czechia
    • Ps0003 351
  • Praha, Czechia
    • Ps0003 352
  • Ústí nad Labem, Czechia
    • Ps0003 350
  • District Of Columbia
    • Pardubice, District Of Columbia, Czechia
      • Ps0003 353
• France
  • Nice cedex 3, France
    • Ps0003 320
  • Toulouse Cedex 9, France
    • Ps0003 325
• Germany
  • Berlin, Germany
    • Ps0003 367
  • Berlin, Germany
    • Ps0003 372
  • Berlin, Germany
    • Ps0003 375
  • Dresden, Germany
    • Ps0003 369
  • Giessen, Germany
    • Ps0003 361
  • Hamburg, Germany
    • Ps0003 362
  • Hannover, Germany
    • Ps0003 366
  • Baden-Wuerttemberg
    • Friedrichshafen, Baden-Wuerttemberg, Germany
      • Ps0003 374
  • Bayern
    • Muenchen, Bayern, Germany
      • Ps0003 373
  • Hessen
    • Frankfurt am Main, Hessen, Germany
      • Ps0003 368
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany
      • Ps0003 378
    • Wuppertal, Nordrhein-Westfalen, Germany
      • Ps0003 371
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany
      • Ps0003 370
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany
      • Ps0003 365
  • Thueringen
    • Erfurt, Thueringen, Germany
      • Ps0003 363
• Hungary
  • Budapest, Hungary
    • Ps0003 382
  • Budapest, Hungary
    • Ps0003 383
  • Budapest, Hungary
    • Ps0003 384
  • Bekes
    • Orosháza, Bekes, Hungary
      • Ps0003 381
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary
      • Ps0003 380
• Netherlands
  • Breda, Netherlands
    • Ps0003 340
• Poland
  • Białystok, Poland
    • Ps0003 425
  • Gdańsk, Poland
    • Ps0003 427
  • Gdynia, Poland
    • Ps0003 423
  • Szczecin, Poland
    • Ps0003 332
  • Warszawa, Poland
    • Ps0003 336
  • Wrocław, Poland
    • Ps0003 339
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland
      • Ps0003 422
  • Kujawsko-pomorskie
    • Torun, Kujawsko-pomorskie, Poland
      • Ps0003 330
  • Lubelskie
    • Lublin, Lubelskie, Poland
      • Ps0003 335
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland
      • Ps0003 338
    • Warszawa, Mazowieckie, Poland
      • Ps0003 421
  • Podlaskie
    • Bialystok, Podlaskie, Poland
      • Ps0003 333
  • Slaskie
    • Katowice, Slaskie, Poland
      • Ps0003 334
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland
      • Ps0003 424
• United Kingdom
  • Edgbaston, United Kingdom
    • Ps0003 393
  • Liverpool, United Kingdom
    • Ps0003 394
  • Manchester, United Kingdom
    • Ps0003 392
  • Angus
    • Dundee, Angus, United Kingdom
      • Ps0003 390
  • Northumberland
    • Hexham, Northumberland, United Kingdom
      • Ps0003 391
  • Wales
    • Cardiff, Wales, United Kingdom
      • Ps0003 395
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Ps0003 317
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Ps0003 306
  • California
    • Beverly Hills, California, United States, 90212
      • Ps0003 301
    • Los Angeles, California, United States, 90045
      • Ps0003 307
    • San Diego, California, United States, 92123
      • Ps0003 405
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Ps0003 316
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Ps0003 304
  • Illinois
    • Springfield, Illinois, United States, 62703
      • Ps0003 302
    • West Dundee, Illinois, United States, 60118
      • Ps0003 313
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Ps0003 310
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Ps0003 400
  • New Jersey
    • Verona, New Jersey, United States, 07044-29
      • Ps0003 319
  • New York
    • Buffalo, New York, United States, 14203
      • Ps0003 404
  • Oregon
    • Portland, Oregon, United States, 97223
      • Ps0003 407
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Ps0003 309
  • Texas
    • Dallas, Texas, United States, 75246
      • Ps0003 401
    • Houston, Texas, United States, 77065
      • Ps0003 403
    • San Antonio, Texas, United States, 78213
      • Ps0003 406
    • Webster, Texas, United States, 77598
      • Ps0003 311

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CZP 200 mg; 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.	Biological: Certolizumab Pegol; Active Substance: Certolizumab Pegol; Pharmaceutical Form: Solution for injection in pre-filled syringe; Concentration: 200 mg/ mL; Route of Administration: Subcutaneous use; Other Names: Cimzia; CZP; CDP870
Experimental: CZP 400 mg; 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.	Biological: Certolizumab Pegol; Active Substance: Certolizumab Pegol; Pharmaceutical Form: Solution for injection in pre-filled syringe; Concentration: 200 mg/ mL; Route of Administration: Subcutaneous use; Other Names: Cimzia; CZP; CDP870
Active Comparator: Etanercept; 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.	Biological: Etanercept; Active Substance: Etanercept; Pharmaceutical Form: Solution for injection in pre-filled syringe; Concentration: 50 mg / mL; Route of Administration: Subcutaneous use; Other Names: ETN; Enbrel
Placebo Comparator: Placebo; 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.	Other: Placebo; Active Substance: Placebo; Pharmaceutical Form: Solution for injection in pre-filled syringe; Concentration: 0.9 % saline; Route of Administration: Subcutaneous use; Other Names: PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
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.	Week 12
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.	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	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
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.	Week 16
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.	Week 48

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 11, 2015
• Primary Completion (Actual): March 22, 2016
• Study Completion (Actual): December 17, 2018

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Psoriasis; Cimzia; Certolizumab Pegol
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept; Certolizumab Pegol
• Other Study ID Numbers: PS0003; 2014-003492-36 (EudraCT Number)

Drug and device information, study documents

• 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