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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
BMS-986165
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0014
  • Local Institution
  • Fukuoka University Hospital
  • University of Occupational and Environmental Health, Japan
  • Sapporo Skin Clinic
  • Kobe University Hospital
  • Local Institution
  • Tokai University Hospital
  • National Hospital Organization Yokohama Medical Center
  • Yokohama City University Hospital
  • Kochi Medical School Hospital
  • University Hospital - Kyoto Preferctural University of Medicine
  • Kyoto University Hospital
  • Mie University Hospital
  • Local Institution - 0004
  • Kurashiki Central Hospital
  • Hamamatsu University Hospital
  • Jichi Medical University Hospital
  • Nihon University Itabashi Hospital
  • Teikyo University Hospital
  • The Jikei University Hospital
  • NTT Medical Center Tokyo
  • Tokyo Medical University Hospital
  • Japan Community Health Care Organization Tokyo Yamate Medical Center
  • Kumamoto University Hospital
  • Local Institution - 0003
  • Local Institution - 0012

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-986165

Arm Description

Given daily

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2019
Last Updated
October 6, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03924427
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165
Arm Type
Experimental
Arm Description
Given daily
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Oral tablet administration
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
Week 16
Title
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
Description
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.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Guttate, inverse, or drug-induced psoriasis at Screening or Baseline History of recent infection Prior exposure to BMS-986165 Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0014
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution
City
Toon-Shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
University of Occupational and Environmental Health, Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Local Institution
City
Morioka
State/Province
Iwate
ZIP/Postal Code
0208505
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara City
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2458575
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kochi Medical School Hospital
City
Nakoku
State/Province
Kochi
ZIP/Postal Code
783-8505
Country
Japan
Facility Name
University Hospital - Kyoto Preferctural University of Medicine
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto-City
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Mie University Hospital
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Local Institution - 0004
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
3908621
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
7108602
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Teikyo University Hospital
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-8605
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Japan Community Health Care Organization Tokyo Yamate Medical Center
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Local Institution - 0003
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Local Institution - 0012
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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