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

NCT03924427 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IM011-066
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  Week 16

• 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

  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.

  Week 16

Study Arms (1)

BMS-986165

EXPERIMENTAL

Given daily

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Oral tablet administration

BMS-986165

Eligibility Criteria

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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (27)

Local Institution - 0014

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution

Toon-Shi, Ehime, 791-0295, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, 807-8555, Japan

Location

Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Local Institution

Morioka, Iwate, 0208505, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 2458575, Japan

Location

Kochi Medical School Hospital

Nakoku, Kochi, 783-8505, Japan

Location

University Hospital - Kyoto Preferctural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

Local Institution - 0004

Matsumoto, Nagano, 3908621, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 7108602, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329-0498, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, 105-8471, Japan

Location

NTT Medical Center Tokyo

Shinagawa, Tokyo, 141-8625, Japan

Location

Japan Community Health Care Organization Tokyo Yamate Medical Center

Shinjuku, Tokyo, 169-0073, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 1600023, Japan

Location

Teikyo University Hospital

tabashi City, Tokyo, 173-8605, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Local Institution - 0003

Osaka, 545-8586, Japan

Location

Local Institution - 0012

Osaka, 550-0006, Japan

Location

Related Publications (2)

• 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.

  PMID: 40304108 DERIVED

• 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.

  PMID: 40066907 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: April 10, 2019
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: November 2, 2022
• Results First Posted: November 2, 2022

Record last verified: 2022-10

Locations

JP (27)