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Trial record 2 of 33 for:    BMS-986165

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

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ClinicalTrials.gov Identifier: NCT04036435
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : October 9, 2019
Sponsor:
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
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 : July 19, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 1, 2022

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04036435


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Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04036435     History of Changes
Other Study ID Numbers: IM011-075
2019-000612-29 ( Registry Identifier: EudraCT )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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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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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases