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

An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BMS-986165

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Osaka, Japan, 545-8586
    • Local Institution - 0003
  • Osaka, Japan, 550-0006
    • Local Institution - 0012
  • Aichi
    • Nagoya, Aichi, Japan, 467-8602
      • Local Institution - 0014
  • Ehime
    • Toon-Shi, Ehime, Japan, 791-0295
      • Local Institution
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
    • Kitakyushu, Fukuoka, Japan, 807-8555
      • University of Occupational and Environmental Health, Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0063
      • Sapporo Skin Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Iwate
    • Morioka, Iwate, Japan, 0208505
      • Local Institution
  • Kanagawa
    • Isehara City, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
    • Yokohama-shi, Kanagawa, Japan, 2458575
      • National Hospital Organization Yokohama Medical Center
  • Kochi
    • Nakoku, Kochi, Japan, 783-8505
      • Kochi Medical School Hospital
  • Kyoto
    • Kyoto-City, Kyoto, Japan, 606-8507
      • Kyoto University Hospital
    • Kyoto-city, Kyoto, Japan, 602-8566
      • University Hospital - Kyoto Preferctural University of Medicine
  • MIE
    • Tsu, MIE, Japan, 514-8507
      • Mie University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 3908621
      • Local Institution - 0004
  • Okayama
    • Kurashiki, Okayama, Japan, 7108602
      • Kurashiki Central Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tochigi
    • Shimotsuke, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Itabashi, Tokyo, Japan, 173-8605
      • Teikyo University Hospital
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
    • Shinagawa, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo
    • Shinjuku, Tokyo, Japan, 169-0073
      • Japan Community Health Care Organization Tokyo Yamate Medical Center
    • Shinjuku-ku, Tokyo, Japan, 1600023
      • Tokyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986165; Given daily	Drug: BMS-986165; Oral tablet administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): March 24, 2021
• Study Completion (Actual): March 24, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes