Clinical trial NCT02346240: Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Plaque Psoriasis
Keywords: Certolizumab Pegol
Cimzia
Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 12
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
timeFrame: Week 12
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
timeFrame: Week 16
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16
timeFrame: Week 48
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Ps0003 317
state: Alabama
city: Little Rock
country: United States
facility: Ps0003 306
state: Arkansas
city: Beverly Hills
country: United States
facility: Ps0003 301
state: California
city: Los Angeles
country: United States
facility: Ps0003 307
state: California
city: San Diego
country: United States
facility: Ps0003 405
state: California
city: Washington
country: United States
facility: Ps0003 316
state: District of Columbia
city: West Palm Beach
country: United States
facility: Ps0003 304
state: Florida
city: Springfield
country: United States
facility: Ps0003 302
state: Illinois
city: West Dundee
country: United States
facility: Ps0003 313
state: Illinois
city: Indianapolis
country: United States
facility: Ps0003 310
state: Indiana
city: Henderson
country: United States
facility: Ps0003 400
state: Nevada
city: Verona
country: United States
facility: Ps0003 319
state: New Jersey
city: Buffalo
country: United States
facility: Ps0003 404
state: New York
city: Portland
country: United States
facility: Ps0003 407
state: Oregon
city: Johnston
country: United States
facility: Ps0003 309
state: Rhode Island
city: Dallas
country: United States
facility: Ps0003 401
state: Texas
city: Houston
country: United States
facility: Ps0003 403
state: Texas
city: San Antonio
country: United States
facility: Ps0003 406
state: Texas
city: Webster
country: United States
facility: Ps0003 311
state: Texas
city: Dupnitsa
country: Bulgaria
facility: Ps0003 345
state: Kyustendil
city: Sofia
country: Bulgaria
facility: Ps0003 343
state: Sofia-Grad
city: Plovdiv
country: Bulgaria
facility: Ps0003 344
city: Varna
country: Bulgaria
facility: Ps0003 342
city: Pardubice
country: Czechia
facility: Ps0003 353
state: District Of Columbia
city: Pardubice
country: Czechia
facility: Ps0003 351
city: Praha
country: Czechia
facility: Ps0003 352
city: Ústí nad Labem
country: Czechia
facility: Ps0003 350
city: Nice cedex 3
country: France
facility: Ps0003 320
city: Toulouse Cedex 9
country: France
facility: Ps0003 325
city: Friedrichshafen
country: Germany
facility: Ps0003 374
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: Ps0003 373
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Ps0003 368
state: Hessen
city: Bochum
country: Germany
facility: Ps0003 378
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: Ps0003 371
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Ps0003 370
state: Rheinland-Pfalz
city: Kiel
country: Germany
facility: Ps0003 365
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Ps0003 363
state: Thueringen
city: Berlin
country: Germany
facility: Ps0003 367
city: Berlin
country: Germany
facility: Ps0003 372
city: Berlin
country: Germany
facility: Ps0003 375
city: Dresden
country: Germany
facility: Ps0003 369
city: Giessen
country: Germany
facility: Ps0003 361
city: Hamburg
country: Germany
facility: Ps0003 362
city: Hannover
country: Germany
facility: Ps0003 366
city: Orosháza
country: Hungary
facility: Ps0003 381
state: Bekes
city: Debrecen
country: Hungary
facility: Ps0003 380
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Ps0003 382
city: Budapest
country: Hungary
facility: Ps0003 383
city: Budapest
country: Hungary
facility: Ps0003 384
city: Breda
country: Netherlands
facility: Ps0003 340
city: Wrocław
country: Poland
facility: Ps0003 422
state: Dolnoslaskie
city: Torun
country: Poland
facility: Ps0003 330
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Ps0003 335
state: Lubelskie
city: Warszawa
country: Poland
facility: Ps0003 338
state: Mazowieckie
city: Warszawa
country: Poland
facility: Ps0003 421
state: Mazowieckie
city: Bialystok
country: Poland
facility: Ps0003 333
state: Podlaskie
city: Katowice
country: Poland
facility: Ps0003 334
state: Slaskie
city: Poznań
country: Poland
facility: Ps0003 424
state: Wielkopolskie
city: Białystok
country: Poland
facility: Ps0003 425
city: Gdańsk
country: Poland
facility: Ps0003 427
city: Gdynia
country: Poland
facility: Ps0003 423
city: Szczecin
country: Poland
facility: Ps0003 332
city: Warszawa
country: Poland
facility: Ps0003 336
city: Wrocław
country: Poland
facility: Ps0003 339
city: Dundee
country: United Kingdom
facility: Ps0003 390
state: Angus
city: Hexham
country: United Kingdom
facility: Ps0003 391
state: Northumberland
city: Cardiff
country: United Kingdom
facility: Ps0003 395
state: Wales
city: Edgbaston
country: United Kingdom
facility: Ps0003 393
city: Liverpool
country: United Kingdom
facility: Ps0003 394
city: Manchester
country: United Kingdom
facility: Ps0003 392
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
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.
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.
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.