Clinical trial NCT02326298: An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind 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: 2014-12-29
Enrollment: 234
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 in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

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 Treatment Period from Week 48 to Week 144
* Safety Follow-Up Period from Week 144 to Week 152

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 Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
* 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 16
timeFrame: At Week 16
measure: Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
timeFrame: At Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: At Week 16
measure: Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48
timeFrame: At Week 48
measure: Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48
timeFrame: At Week 48
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Ps0005 504
state: California
city: West Des Moines
country: United States
facility: Ps0005 502
state: Iowa
city: Baton Rouge
country: United States
facility: Ps0005 500
state: Louisiana
city: Boston
country: United States
facility: Ps0005 506
state: Massachusetts
city: Saint Louis
country: United States
facility: Ps0005 505
state: Missouri
city: Albuquerque
country: United States
facility: Ps0005 507
state: New Mexico
city: Nashville
country: United States
facility: Ps0005 508
state: Tennessee
city: Houston
country: United States
facility: Ps0005 501
state: Texas
city: Edmonton
country: Canada
facility: Ps0005 597
state: Alberta
city: Surrey
country: Canada
facility: Ps0005 591
state: British Columbia
city: Ajax
country: Canada
facility: Ps0005 596
state: Ontario
city: Hamilton
country: Canada
facility: Ps0005 590
state: Ontario
city: Toronto
country: Canada
facility: Ps0005 593
state: Ontario
city: Drummondville
country: Canada
facility: Ps0005 595
state: Quebec
city: Quebec City
country: Canada
facility: Ps0005 594
state: Quebec
city: Nachod
country: Czechia
facility: Ps0005 553
city: Olomouc
country: Czechia
facility: Ps0005 550
city: Ostrava-Poruba
country: Czechia
facility: Ps0005 551
city: Praha 10
country: Czechia
facility: Ps0005 552
city: Mahlow
country: Germany
facility: Ps0005 562
state: Brandenburg
city: Witten
country: Germany
facility: Ps0005 565
state: Nordrhein-Westfalen
city: Lubeck
country: Germany
facility: Ps0005 569
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Ps0005 560
city: Dresden
country: Germany
facility: Ps0005 561
city: Hamburg
country: Germany
facility: Ps0005 563
city: Hamburg
country: Germany
facility: Ps0005 568
city: Kiel
country: Germany
facility: Ps0005 566
city: Orosháza
country: Hungary
facility: Ps0005 580
state: Bekes
city: Budapest
country: Hungary
facility: Ps0005 582
city: Pecs
country: Hungary
facility: Ps0005 581
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Gottlieb AB, Blauvelt A, Thaci D, Leonardi CL, Poulin Y, Drew J, Peterson L, Arendt C, Burge D, Reich K. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018 Aug;79(2):302-314.e6. doi: 10.1016/j.jaad.2018.04.012. Epub 2018 Apr 13.
citation: Gordon KB, Warren RB, Gottlieb AB, Blauvelt A, Thaci D, Leonardi C, Poulin Y, Boehnlein M, Brock F, Ecoffet C, Reich K. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. doi: 10.1111/bjd.19393. Epub 2020 Sep 9.
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.