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

NCT ID: NCT03924427

Last Updated: 2022-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2021-03-24

Brief Summary

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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986165

Given daily

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral tablet administration

Interventions

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BMS-986165

Oral tablet administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0014

Nagoya, Aichi-ken, Japan

Site Status

Local Institution

Toon-Shi, Ehime, Japan

Site Status

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Site Status

University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, Japan

Site Status

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Site Status

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status

Local Institution

Morioka, Iwate, Japan

Site Status

Tokai University Hospital

Isehara, Kanagawa, Japan

Site Status

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Site Status

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, Japan

Site Status

Kochi Medical School Hospital

Nakoku, Kochi, Japan

Site Status

University Hospital - Kyoto Preferctural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Mie University Hospital

Tsu, Mie-ken, Japan

Site Status

Local Institution - 0004

Matsumoto, Nagano, Japan

Site Status

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Site Status

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Site Status

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Site Status

NTT Medical Center Tokyo

Shinagawa, Tokyo, Japan

Site Status

Japan Community Health Care Organization Tokyo Yamate Medical Center

Shinjuku, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Teikyo University Hospital

tabashi City, Tokyo, Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Local Institution - 0003

Osaka, , Japan

Site Status

Local Institution - 0012

Osaka, , Japan

Site Status

Countries

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Japan

References

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Okubo Y, Morita A, Imafuku S, Tada Y, Tsuritani K, Shao Y, Popmihajlov Z, Napoli A, Hippeli L, Habiro K, Ohtsuki M. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Japanese Patients With Plaque Psoriasis: In-Depth Analysis of Efficacy and Safety in the Phase 3 POETYK PSO-4 Trial. J Dermatol. 2025 Jun;52(6):953-966. doi: 10.1111/1346-8138.17744. Epub 2025 Apr 30.

Reference Type DERIVED
PMID: 40304108 (View on PubMed)

Morita A, Imafuku S, Tada Y, Okubo Y, Habiro K, Tsuritani K, Banerjee S, Hoyt K, Kisa RM, Ohtsuki M. Deucravacitinib in plaque psoriasis: Safety and efficacy through 3 years in Japanese patients in the phase 3 POETYK PSO-1, PSO-4, and LTE trials. J Dermatol. 2025 May;52(5):761-772. doi: 10.1111/1346-8138.17685. Epub 2025 Mar 11.

Reference Type DERIVED
PMID: 40066907 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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IM011-066

Identifier Type: -

Identifier Source: org_study_id

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