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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03924427

Recruitment Status Active, not recruiting

First Posted April 23, 2019

Last update posted March 4, 2020

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:Psoriasis
  • Intervention/Treatment: Drug: BMS-986165
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: November 2020
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 [ 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations
Show 27 Study Locations
Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information
  • 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: March 4, 2020
  • Last Verified: March 2020
  • 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