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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924427
• Other study ID #: IM011-066
• Status: Completed
• Phase: Phase 3
• Start date: April 10, 2019
• Est. completion date: March 24, 2021

Study information

• Verified date: October 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 24, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Oral tablet administration

Locations

Country	Name	City	State
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Tokai University Hospital	Isehara City	Kanagawa
Japan	Teikyo University Hospital	Itabashi	Tokyo
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	University of Occupational and Environmental Health, Japan	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Kyoto University Hospital	Kyoto-City	Kyoto
Japan	University Hospital - Kyoto Preferctural University of Medicine	Kyoto-city	Kyoto
Japan	Local Institution - 0004	Matsumoto	Nagano
Japan	The Jikei University Hospital	Minato-ku	Tokyo
Japan	Local Institution	Morioka	Iwate
Japan	Local Institution - 0014	Nagoya	Aichi
Japan	Kochi Medical School Hospital	Nakoku	Kochi
Japan	Local Institution - 0003	Osaka
Japan	Local Institution - 0012	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	NTT Medical Center Tokyo	Shinagawa	Tokyo
Japan	Japan Community Health Care Organization Tokyo Yamate Medical Center	Shinjuku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Local Institution	Toon-Shi	Ehime
Japan	Mie University Hospital	Tsu	MIE
Japan	Yokohama City University Hospital	Yokohama	Kanagawa
Japan	National Hospital Organization Yokohama Medical Center	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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