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Clinical Trials/2022-502361-15-00
2022-502361-15-00
Active, not recruiting
Phase 3

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

Bristol Myers Squibb International Corporation60 sites in 5 countries664 target enrollmentStarted: April 5, 2024Last updated:
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Interventionsdeucravacitinib

Overview

Phase
Phase 3
Status
Active, not recruiting
Enrollment
664
Locations
60
Primary Endpoint
Adverse events and serious adverse events
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis
  • •Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF)
  • •Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period(must have a negative urine test 24 hours prior to the start of study drug)

Exclusion Criteria

  • •Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason
  • •Prior permanent discontinuation of study treatment in the parent study
  • •Findings Related to Possible TB Infection
  • •Evidence of active TB

Arms & Interventions

deucravacitinib

Experimental

Participants receiving deucravacitinib

Intervention: deucravacitinib (Drug)

Outcomes

Primary Outcomes

Adverse events and serious adverse events

Adverse events and serious adverse events

Secondary Outcomes

  • sPGA 0/1 response
  • PASI 75 response

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

GCT-SU

Scientific

Bristol-Myers Squibb Services Unlimited Company

Study Sites (60)

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