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

NCT03051217 | Completed Phase 2 Results

• 1 other identifier: PS0017
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 33

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

Keywords

Psoriasis; PSO; Chronic plaque psoriasis; Certolizumb Pegol; Cimzia; Generalized pustular psoriasis and erythrodermic psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

  The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

  Week 16

Secondary Outcomes (6)

• 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

  Week 16

• Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

  Week 16

• Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  Baseline and Week 16

• Change From Baseline in Itch Numeric Rating Scale at Week 16

  Baseline and Week 16

• Plasma Concentration of Certolizumab Pegol (CZP)

  Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

CZP 200 mg

EXPERIMENTAL

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

Other: Placebo; Drug: Certolizumab Pegol

CZP 400 mg

EXPERIMENTAL

Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).

Drug: Certolizumab Pegol

Interventions

Placebo OTHER

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

Also known as: PBO

CZP 200 mg; Placebo

Certolizumab Pegol DRUG

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

Also known as: Cimzia, CDP870, CZP

CZP 200 mg; CZP 400 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (33)

Ps0017 024

Asahikawa, Japan

Location

Ps0017 012

Bunkyō City, Japan

Location

Ps0017 010

Chiyoda-Ku, Japan

Location

Ps0017 007

Chūōku, Japan

Location

Ps0017 004

Fukuoka, Japan

Location

Ps0017 039

Fukushima, Japan

Location

Ps0017 028

Gifu, Japan

Location

Ps0017 040

Hamamatsu, Japan

Location

Ps0017 013

Itabashi-Ku, Japan

Location

Ps0017 022

Kobe, Japan

Location

Ps0017 032

Kumamoto, Japan

Location

Ps0017 031

Kurume, Japan

Location

Ps0017 021

Kyoto, Japan

Location

Ps0017 041

Matsumoto, Japan

Location

Ps0017 009

Minatoku, Japan

Location

Ps0017 033

Miyazaki, Japan

Location

Ps0017 016

Nagoya, Japan

Location

Ps0017 029

Nankoku, Japan

Location

Ps0017 005

Obihiro, Japan

Location

Ps0017 017

Osaka, Japan

Location

Ps0017 042

Osaka, Japan

Location

Ps0017 037

Ōsaka-sayama, Japan

Location

Ps0017 001

Sapporo, Japan

Location

Ps0017 027

Sendai, Japan

Location

Ps0017 015

Shimotsuke, Japan

Location

Ps0017 008

Shinagawa-Ku, Japan

Location

Ps0017 002

Shinjuku, Japan

Location

Ps0017 003

Shinjuku, Japan

Location

Ps0017 011

Shinjuku, Japan

Location

Ps0017 014

Shinjuku, Japan

Location

Ps0017 034

Sumida City, Japan

Location

Ps0017 038

Takaoka, Japan

Location

Ps0017 025

Tsu, Japan

Location

Related Publications (4)

• 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.

  PMID: 34826124 RESULT

• 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.

  PMID: 35622315 DERIVED

• 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.

  PMID: 33886085 DERIVED

• 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.

  PMID: 33606269 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  UCB (+1 844 599 2273)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: February 21, 2017
• Primary Completion: November 19, 2018
• Study Completion: January 16, 2019
• Last Updated: January 4, 2022
• Results First Posted: December 11, 2019

Record last verified: 2020-11

Locations

JP (33)