A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

NCT ID: NCT03051217

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2019-01-16

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.

Conditions

Moderate to Severe Psoriasis; Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo subcutaneous (sc) injection every two weeks (Q2W)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Concentration: 0.9 % saline
• Route of Administration: Subcutaneous use Q2W

CZP 200 mg

Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Concentration: 0.9 % saline
• Route of Administration: Subcutaneous use Q2W

Certolizumab Pegol

Intervention Type: DRUG

• 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).

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: DRUG

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Concentration: 200 mg/mL
• Route of Administration: Subcutaneous use

Interventions

Placebo

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Concentration: 0.9 % saline
• Route of Administration: Subcutaneous use Q2W

Intervention Type: OTHER

Certolizumab Pegol

• Pharmaceutical Form: Solution for injection in pre-filled syringe
• Concentration: 200 mg/mL
• Route of Administration: Subcutaneous use

Intervention Type: DRUG

Other Intervention Names

PBO; Cimzia; CDP870; CZP

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.

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

UCB (+1 844 599 2273)

Locations

Ps0017 024

Asahikawa, , Japan

Ps0017 012

Bunkyō City, , Japan

Ps0017 010

Chiyoda-Ku, , Japan

Ps0017 007

Chūōku, , Japan

Ps0017 004

Fukuoka, , Japan

Ps0017 039

Fukushima, , Japan

Ps0017 028

Gifu, , Japan

Ps0017 040

Hamamatsu, , Japan

Ps0017 013

Itabashi-Ku, , Japan

Ps0017 022

Kobe, , Japan

Ps0017 032

Kumamoto, , Japan

Ps0017 031

Kurume, , Japan

Ps0017 021

Kyoto, , Japan

Ps0017 041

Matsumoto, , Japan

Ps0017 009

Minatoku, , Japan

Ps0017 033

Miyazaki, , Japan

Ps0017 016

Nagoya, , Japan

Ps0017 029

Nankoku, , Japan

Ps0017 005

Obihiro, , Japan

Ps0017 017

Osaka, , Japan

Ps0017 042

Osaka, , Japan

Ps0017 037

Ōsaka-sayama, , Japan

Ps0017 001

Sapporo, , Japan

Ps0017 027

Sendai, , Japan

Ps0017 015

Shimotsuke, , Japan

Ps0017 008

Shinagawa-Ku, , Japan

Ps0017 002

Shinjuku, , Japan

Ps0017 003

Shinjuku, , Japan

Ps0017 011

Shinjuku, , Japan

Ps0017 014

Shinjuku, , Japan

Ps0017 034

Sumida City, , Japan

Ps0017 038

Takaoka, , Japan

Ps0017 025

Tsu, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 34826124 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35622315 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33886085 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33606269 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

PS0017

Identifier Type: -

Identifier Source: org_study_id