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Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis (POETYK PSO-LTE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036435
Recruitment Status : Active, not recruiting
First Posted : July 29, 2019
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1452 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 : August 12, 2019
Estimated Primary Completion Date : July 25, 2026
Estimated Study Completion Date : July 26, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986165 Drug: BMS-986165
Specified dose on specified days
Other Name: Deucravacitinib


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 244 weeks ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 244 weeks ]

Secondary Outcome Measures :
  1. static Physician Global Assessment (sPGA) 0/1 response [ Time Frame: Up to 240 weeks ]
  2. Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: Up to 240 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (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.

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov 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: September 28, 2023
Last Verified: September 2023

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