An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: BMS-986165

• Registration Number: NCT03924427
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Primary Completion: 2021-03-24
• Study Completion: 2021-03-24
• Disposition First Submitted: 2022-03-21
• Disposition First Submitted QC: 2022-03-21
• Disposition First Posted: 2022-03-22
• Status Verified: 2022-10
• Results First Submitted: 2022-10-06
• Results First Submitted QC: 2022-10-06
• Last Update Submitted: 2022-10-06
• Results First Posted: 2022-11-02
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

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Exclusion Criteria

1. Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
2. History of recent infection
3. Prior exposure to BMS-986165

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165	BMS-986165	Given daily

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16	Week 16	PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method.
Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16	Week 16	The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity: * Clear (0); * Almost clear (1); * Mild (2); * Moderate (3); * Severe (4)

Trial Locations

Locations (26)

Yokohama City University Hospital; 🇯🇵 Yokohama, Kanagawa, Japan

Hamamatsu University Hospital; 🇯🇵 Hamamatsu, Shizuoka, Japan

Kyoto University Hospital; 🇯🇵 Kyoto-City, Kyoto, Japan

Local Institution - 0014; 🇯🇵 Nagoya, Aichi, Japan

Local Institution; 🇯🇵 Morioka, Iwate, Japan

Sapporo Skin Clinic; 🇯🇵 Sapporo, Hokkaido, Japan

National Hospital Organization Yokohama Medical Center; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Kochi Medical School Hospital; 🇯🇵 Nakoku, Kochi, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Teikyo University Hospital; 🇯🇵 Itabashi, Tokyo, Japan

Nihon University Itabashi Hospital; 🇯🇵 Itabashi-ku, Tokyo, Japan

The Jikei University Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

NTT Medical Center Tokyo; 🇯🇵 Shinagawa, Tokyo, Japan

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan

Local Institution - 0003; 🇯🇵 Osaka, Japan

Fukuoka University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

University of Occupational and Environmental Health, Japan; 🇯🇵 Kitakyushu, Fukuoka, Japan

Local Institution - 0004; 🇯🇵 Matsumoto, Nagano, Japan

Tokai University Hospital; 🇯🇵 Isehara City, Kanagawa, Japan

Japan Community Health Care Organization Tokyo Yamate Medical Center; 🇯🇵 Shinjuku, Tokyo, Japan

Kobe University Hospital; 🇯🇵 Kobe, Hyogo, Japan

University Hospital - Kyoto Preferctural University of Medicine; 🇯🇵 Kyoto-city, Kyoto, Japan

Mie University Hospital; 🇯🇵 Tsu, MIE, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Jichi Medical University Hospital; 🇯🇵 Shimotsuke, Tochigi, Japan

Local Institution - 0012; 🇯🇵 Osaka, Japan