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

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ClinicalTrials.gov Identifier: NCT03924427
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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 : April 10, 2019
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : November 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 52 weeks ]
    At least 90% improvement in PASI scores from baseline.

  4. Percentage of participants who achieve PASI 100 [ Time Frame: 52 weeks ]
    100% improvement in PASI scores from baseline.

  5. American College of Rheumatology Criteria (ACR20) response in participants with psoriatic arthritis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 52 weeks ]
    Severity of palmoplantar psoriasis as measured by pp-PGA.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924427


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT # and Site #.

Locations
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Japan
Local Institution Recruiting
Nagoya, Aichi, Japan, 467-8602
Contact: Site 0014         
Local Institution Not yet recruiting
Toon-Shi, Ehime, Japan, 791-0295
Contact: Site 0013         
Local Institution Recruiting
Fukuoka-shi, Fukuoka, Japan, 814-0180
Contact: Site 0010         
Local Institution Not yet recruiting
Kitakyushu, Fukuoka, Japan, 807-8555
Contact: Site 0002         
Local Institution Recruiting
Sapporo, Hokkaido, Japan, 060-0063
Contact: Site 0021         
Local Institution Not yet recruiting
Kobe, Hyogo, Japan, 6500017
Contact: Site 0011         
Local Institution Not yet recruiting
Morioka, Iwate, Japan, 0208505
Contact: Site 0008         
Local Institution Recruiting
Isehara City, Kanagawa, Japan, 259-1193
Contact: Site 0023         
Local Institution Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Contact: Site 0001         
Local Institution Not yet recruiting
Yokohama-shi, Kanagawa, Japan, 2458575
Contact: Site 0024         
Local Institution Not yet recruiting
Nakoku, Kochi, Japan, 783-8505
Contact: Site 0025         
Local Institution Not yet recruiting
Kyoto-city, Kyoto, Japan, 602-8566
Contact: Site 0022         
Local Institution Recruiting
Tsu, MIE, Japan, 514-8507
Contact: Site 0007         
Local Institution Recruiting
Matsumoto, Nagano, Japan, 3908621
Contact: Site 0004         
Local Institution Recruiting
Kurashiki, Okayama, Japan, 7108602
Contact: Site 0026         
Local Institution Not yet recruiting
Osaka-shi, Osaka, Japan, 5458586
Contact: Site 0003         
Local Institution Recruiting
Hamamatsu, Shizuoka, Japan, 431-1192
Contact: Site 0006         
Local Institution Recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Contact: Site 0020         
Local Institution Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Contact: Site 0027         
Local Institution Recruiting
Itabashi, Tokyo, Japan, 173-8605
Contact: Site 0018         
Local Institution Recruiting
Minato-ku, Tokyo, Japan, 105-8471
Contact: Site 0019         
Local Institution Not yet recruiting
Shinagawa, Tokyo, Japan, 141-8625
Contact: Site 0017         
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 1600023
Contact: Site 0016         
Local Institution Recruiting
Shinjuku, Tokyo, Japan, 169-0073
Contact: Site 0015         
Local Institution Recruiting
Kumamoto, Japan, 860-8556
Contact: Site 0009         
Local Institution Not yet recruiting
Kyoto, Japan, 606-8507
Contact: Site 0005         
Local Institution Not yet recruiting
Osaka, Japan, 550-0006
Contact: Site 0012         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03924427     History of Changes
Other Study ID Numbers: IM011-066
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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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:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases