Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers

NCT07791199
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Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
2,300
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Lead sponsor
Bristol-Myers Squibb
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Start date
2026-09-02
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Summary
This study is designed to provide treatment with deucravacitinib for participants with SLE/SjD (Systemic Lupus Erythematosus/Sjögren's Disease) and pediatric participants with PsO/PsA (Psoriasis/Psoriatic Arthritis) who have completed their qualified parent studies and/or long-term extension if applicable.
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Short title
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
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Official title
A Continuation Protocol for Deucravacitinib in Adult Patients With Systemic Lupus Erythematosus (SLE) or Sjögren's Disease (SjD) and Pediatric Patients With Psoriasis (PsO) or Psoriatic Arthritis (PsA) Who Have Completed Parent Studies
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-10-31
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First posted
2026-08-27
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Registry last updated
2026-08-27
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Primary completion date
2030-10-31
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Start date
2026-09-02
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Participants
2,300
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Participant count basis
Estimated
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Planned participants
2,300
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07791199
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ClinicalTrials.gov ID
NCT07791199
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants treated

    Timeframe: Up to approximately 28 days after last dose of deucravacitinib

Sources for outcomes
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Sex
All
Age groups
Children, Adults, Older adults
Minimum age
4 Years
Maximum age
75 Years
Healthy volunteers
No

  • Participants must have completed qualifying parent study through the protocol required treatment period. Qualifying studies include IM011-246, IM011-247, IM011-1069, IM011-126, IM011-1128, and IM011-1071.

  • Participants must not have any disease or medical condition that, in the opinion of the physician, would make them unsuitable for this protocol, would interfere with the interpretation of their safety or considered unsuitable by the physician for any other reason.

Other protocol-defined inclusion/exclusion criteria apply.

Sources for eligibility
clinicaltrials.gov

Other registry identifiers

  • 2026-527576-84
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)