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Long-Term Study That Measures the Safety and Efficacy of BMS-986165 in Participants With Psoriasis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04036435
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The main purpose of this study is to characterize the long-term safety and efficacy of the drug BMS-986165 in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1680 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis.
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 5, 2024
Estimated Study Completion Date : January 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: BMS-986165 Drug: BMS-986165
Participants will receive BMS-986165 in tablet form

Primary Outcome Measures :
  1. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 96 weeks ]

Secondary Outcome Measures :
  1. static Physician Global Assessment (sPGA)0/1 response [ Time Frame: 96 weeks ]
  2. Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: 96 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
  • Women must not be pregnant, lactating, or breastfeeding

Exclusion Criteria:

  • Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study.
  • To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator.

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 identifier (NCT number): NCT04036435

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Contact: Rachel Peterson +1 619 293 6213

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Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT04036435    
Other Study ID Numbers: IM011-075
2019-000612-29 ( Registry Identifier: EudraCT )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action