Clinical trial NCT03051217: A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Official title: Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Moderate to Severe Psoriasis
Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Keywords: Psoriasis
PSO
Chronic plaque psoriasis
Certolizumb Pegol
Cimzia
Generalized pustular psoriasis and erythrodermic psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 127
Sex: ALL
Minimum age (years): 20
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 demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is male or female, \>= 20 years of age.
* Institutional Review Board-approved written informed consent form is signed and dated by the subject.
* Other protocol-defined inclusion criteria may apply.

For subjects with moderate to severe chronic plaque psoriasis (PSO)

* Chronic plaque psoriasis for at least 6 months.
* Baseline Psoriasis Activity and Severity Index (PASI) \>=12 and Body Surface Area (BSA) affected by PSO \>=10% and Physician's Global Assessment (PGA) score of 3 or higher.
* Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.

For subjects with generalized pustular PSO or erythrodermic PSO

* Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
* History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
* Baseline BSA affected by PSO \>=80% if subjects have a diagnosis of erythrodermic PSO.

Exclusion Criteria:

* Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
* Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
* History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
* History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
* History of other malignancy or concurrent malignancy as described in the protocol.
* Class III or IV congestive heart failure
* History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
* Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
* Concurrent medication restrictions as described in the protocol.
* Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
* Subject has any protocol defined clinically significant laboratory abnormalities at the screening
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage 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: Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
timeFrame: Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Itch Numeric Rating Scale at Week 16
timeFrame: Baseline and Week 16
measure: Plasma Concentration of Certolizumab Pegol (CZP)
timeFrame: Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60
measure: Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma
timeFrame: Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Ps0017 024
city: Bunkyo-Ku
country: Japan
facility: Ps0017 012
city: Chiyoda-Ku
country: Japan
facility: Ps0017 010
city: Chūōku
country: Japan
facility: Ps0017 007
city: Fukuoka
country: Japan
facility: Ps0017 004
city: Fukushima
country: Japan
facility: Ps0017 039
city: Gifu
country: Japan
facility: Ps0017 028
city: Hamamatsu
country: Japan
facility: Ps0017 040
city: Itabashi-Ku
country: Japan
facility: Ps0017 013
city: Kobe
country: Japan
facility: Ps0017 022
city: Kumamoto
country: Japan
facility: Ps0017 032
city: Kurume
country: Japan
facility: Ps0017 031
city: Kyoto
country: Japan
facility: Ps0017 021
city: Matsumoto
country: Japan
facility: Ps0017 041
city: Minatoku
country: Japan
facility: Ps0017 009
city: Miyazaki
country: Japan
facility: Ps0017 033
city: Nagoya
country: Japan
facility: Ps0017 016
city: Nankoku
country: Japan
facility: Ps0017 029
city: Obihiro
country: Japan
facility: Ps0017 005
city: Osaka-Sayama
country: Japan
facility: Ps0017 037
city: Osaka
country: Japan
facility: Ps0017 017
city: Osaka
country: Japan
facility: Ps0017 042
city: Sapporo
country: Japan
facility: Ps0017 001
city: Sendai
country: Japan
facility: Ps0017 027
city: Shimotsuke
country: Japan
facility: Ps0017 015
city: Shinagawa-Ku
country: Japan
facility: Ps0017 008
city: Shinjuku
country: Japan
facility: Ps0017 002
city: Shinjuku
country: Japan
facility: Ps0017 003
city: Shinjuku
country: Japan
facility: Ps0017 011
city: Shinjuku
country: Japan
facility: Ps0017 014
city: Sumida
country: Japan
facility: Ps0017 034
city: Takaoka
country: Japan
facility: Ps0017 038
city: Tsu
country: Japan
facility: Ps0017 025
Study officials:
affiliation: UCB (+1 844 599 2273)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Imafuku S, Tada Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. Dermatol Ther (Heidelb). 2022 Jan;12(1):121-135. doi: 10.1007/s13555-021-00645-2. Epub 2021 Nov 26.
citation: Okubo Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2022 Jun;12(6):1397-1415. doi: 10.1007/s13555-022-00741-x. Epub 2022 May 27.
citation: Umezawa Y, Asahina A, Imafuku S, Tada Y, Sano S, Morita A, Sakurai S, Hoshii N, Tilt N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2021 Jun;11(3):943-960. doi: 10.1007/s13555-021-00520-0. Epub 2021 Apr 22.
citation: Umezawa Y, Sakurai S, Hoshii N, Nakagawa H; PS0017 Study Group. Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):513-528. doi: 10.1007/s13555-021-00494-z. Epub 2021 Feb 19.