Clinical trial NCT02326272: A Study to Evaluate the Efficacy and Safety 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: 227
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.

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 3 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
* 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 Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
timeFrame: Week 16
measure: Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
timeFrame: Week 16
measure: Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48
timeFrame: Week 48
measure: Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48
timeFrame: Week 48
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ps0002 203
state: Arizona
city: Bakersfield
country: United States
facility: Ps0002 214
state: California
city: Santa Monica
country: United States
facility: Ps0002 212
state: California
city: Ormond Beach
country: United States
facility: Ps0002 204
state: Florida
city: Portsmouth
country: United States
facility: Ps0002 207
state: New Hampshire
city: East Windsor
country: United States
facility: Ps0002 202
state: New Jersey
city: New York
country: United States
facility: Ps0002 210
state: New York
city: Rochester
country: United States
facility: Ps0002 206
state: New York
city: Wilmington
country: United States
facility: Ps0002 209
state: North Carolina
city: Cleveland
country: United States
facility: Ps0002 205
state: Ohio
city: Portland
country: United States
facility: Ps0002 200
state: Oregon
city: Greer
country: United States
facility: Ps0002 201
state: South Carolina
city: San Antonio
country: United States
facility: Ps0002 208
state: Texas
city: Richmond
country: United States
facility: Ps0002 213
state: Virginia
city: Graz
country: Austria
facility: Ps0002 253
state: Steiermark
city: Barrie
country: Canada
facility: Ps0002 221
state: Ontario
city: London
country: Canada
facility: Ps0002 223
state: Ontario
city: Peterborough
country: Canada
facility: Ps0002 222
state: Ontario
city: Richmond Hill
country: Canada
facility: Ps0002 220
state: Ontario
city: Waterloo
country: Canada
facility: Ps0002 224
state: Ontario
city: Krakow
country: Poland
facility: Ps0002 232
state: Malopolskie
city: Kielce
country: Poland
facility: Ps0002 230
state: Swietokrzyskie
city: Wrocław
country: Poland
facility: Ps0002 231
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.