Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
NCT ID: NCT02346240
Last Updated: 2021-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
559 participants
INTERVENTIONAL
2015-02-11
2018-12-17
Brief Summary
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Detailed Description
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* 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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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 Subjects who receive unblinded CZP 400 mg Q2W for 16 weeks and do not achieve a PASI50 response will be withdrawn from the study.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.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/ mL
* Route of Administration: Subcutaneous use
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.
Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/ mL
* Route of Administration: Subcutaneous use
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.
Etanercept
* Active Substance: Etanercept
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 50 mg / mL
* Route of Administration: Subcutaneous use
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.
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use
Interventions
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Certolizumab Pegol
* Active Substance: Certolizumab Pegol
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/ mL
* Route of Administration: Subcutaneous use
Etanercept
* Active Substance: Etanercept
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 50 mg / mL
* Route of Administration: Subcutaneous use
Placebo
* Active Substance: Placebo
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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Ps0003 317
Mobile, Alabama, United States
Ps0003 306
Little Rock, Arkansas, United States
Ps0003 301
Beverly Hills, California, United States
Ps0003 307
Los Angeles, California, United States
Ps0003 405
San Diego, California, United States
Ps0003 316
Washington D.C., District of Columbia, United States
Ps0003 304
West Palm Beach, Florida, United States
Ps0003 302
Springfield, Illinois, United States
Ps0003 313
West Dundee, Illinois, United States
Ps0003 310
Indianapolis, Indiana, United States
Ps0003 400
Henderson, Nevada, United States
Ps0003 319
Verona, New Jersey, United States
Ps0003 404
Buffalo, New York, United States
Ps0003 407
Portland, Oregon, United States
Ps0003 309
Johnston, Rhode Island, United States
Ps0003 401
Dallas, Texas, United States
Ps0003 403
Houston, Texas, United States
Ps0003 406
San Antonio, Texas, United States
Ps0003 311
Webster, Texas, 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
Countries
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References
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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.
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.
Related Links
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Other Identifiers
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2014-003492-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PS0003
Identifier Type: -
Identifier Source: org_study_id
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