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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03924427
• Collaborator: (none)
• Enrollment: 74
• Locations: 27
• Arm: 1
• Actual Duration (Months): 23.5
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: BMS-986165	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 10, 2019
• Actual Primary Completion Date: Mar 24, 2021
• Actual Study Completion Date: Mar 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [16 weeks]

   The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale.

2. Percentage of participants who achieve PASI 75 (75% reduction in Psoriasis Area and Severity Index) [16 weeks]

   The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).

Secondary Outcome Measures

1. Percentage of participants who achieve sPGA score of 0 or 1 response [52 weeks]

   The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale.

2. Percentage of participants who achieve PASI 75 [52 weeks]

   The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).

3. Percentage of participants who achieve PASI 90 [52 weeks]

   At least 90% improvement in PASI scores from baseline.

4. Percentage of participants who achieve PASI 100 [52 weeks]

   100% improvement in PASI scores from baseline.

5. American College of Rheumatology Criteria (ACR20) response in participants with psoriatic arthritis [52 weeks]

   Assessed as a proportion of participants meeting ACR20 criteria, where a responder is defined if the following 3 conditions are met: ≥ 20% improvement from baseline in the number of tender joints (68 joint count) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count) ≥ 20% improvement from baseline in 3 of the following 5 domains: Patient Global Assessment of joint disease (measured on a Visual Analogue Scale (VAS), 0-100) Physician Global Assessment of joint disease (measured on a VAS, 0-100) Patient assessment of joint pain (measured on a VAS, 0-100) Health Assessment Questionnaire- Disability Index (HAQ-DI) high-sensitivity C-reactive protein (hs-CRP)

6. Change from baseline in the ACR core set in participants with psoriatic arthritis [52 weeks]

   Tender and swollen joint counts Patient global assessment of joint disease Physician global assessment of joint disease Patient assessment of joint pain HAQ-DI hs-CRP

7. Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score [52 weeks]

   PSSD symptom score of 0 assessed as a proportion of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥ 1

8. Percentage of participants who achieve Scalp Specific (ss)-PGA score 0 or 1 among participants with a baseline ss-PGA score ≥3 [52 weeks]

   Severity of scalp psoriasis lesions as measured by ss-PGA

9. Percentage of participants who achieve PGA-F score 0 or 1 among participants with a baseline PGA-F score ≥3 [52 weeks]

   Severity of fingernail psoriasis as measured by PGA-F among participants with a baseline PGA-F score >= 3

10. Percentage of participants who achieve palmoplantar (pp)-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3 [52 weeks]

    Severity of palmoplantar psoriasis as measured by pp-PGA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Inclusion Criteria:

1. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya City University Hospital	Nagoya	Aichi	Japan	467-8602
2	Local Institution	Toon-Shi	Ehime	Japan	791-0295
3	Fukuoka University Hospital	Fukuoka-shi	Fukuoka	Japan	814-0180
4	University of Occupational and Environmental Health, Japan	Kitakyushu	Fukuoka	Japan	807-8555
5	Sapporo Skin Clinic	Sapporo	Hokkaido	Japan	060-0063
6	Kobe University Hospital	Kobe	Hyogo	Japan	650-0017
7	Local Institution	Morioka	Iwate	Japan	0208505
8	Tokai University Hospital	Isehara City	Kanagawa	Japan	259-1193
9	National Hospital Organization Yokohama Medical Center	Yokohama-shi	Kanagawa	Japan	2458575
10	Yokohama City University Hospital	Yokohama	Kanagawa	Japan	236-0004
11	Kochi Medical School Hospital	Nakoku	Kochi	Japan	783-8505
12	University Hospital - Kyoto Preferctural University of Medicine	Kyoto-city	Kyoto	Japan	602-8566
13	Kyoto University Hospital	Kyoto-City	Kyoto	Japan	606-8507
14	Mie University Hospital	Tsu	MIE	Japan	514-8507
15	Shinshu University Hospital	Matsumoto	Nagano	Japan	3908621
16	Kurashiki Central Hospital	Kurashiki	Okayama	Japan	7108602
17	Osaka City University Hospital	Abeno-ku	Osaka	Japan	545-8586
18	Hamamatsu University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
19	Jichi Medical University Hospital	Shimotsuke	Tochigi	Japan	329-0498
20	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo	Japan	173-8610
21	Teikyo University Hospital	Itabashi	Tokyo	Japan	173-8605
22	The Jikei University Hospital	Minato-ku	Tokyo	Japan	105-8471
23	NTT Medical Center Tokyo	Shinagawa	Tokyo	Japan	141-8625
24	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo	Japan	1600023
25	Japan Community Health Care Organization Tokyo Yamate Medical Center	Shinjuku	Tokyo	Japan	169-0073
26	Kumamoto University Hospital	Kumamoto		Japan	860-8556
27	Nippon Life Hospital	Osaka		Japan	550-0006

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03924427
• Other Study ID Numbers: IM011-066
• First Posted: Apr 23, 2019
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• 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
• Additional relevant MeSH terms: Psoriasis; BMS-986165

Study Results

No Results Posted as of Mar 22, 2022