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Not yet recruitingNCT07791199Updated Sep 3, 2026

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

A Phase 3 interventional study of Deucravacitinib in Systemic Lupus Erythematosus, Sjögren's Disease and Psoriasis, sponsored by Bristol-Myers Squibb. Not yet recruiting. Open to participants aged 4 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,300
Allocation
Not applicable
Ages
4 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Lupus Erythematosus
  • Sjögren's Disease
  • Psoriasis
  • Psoriatic Arthritis

Keywords

  • SLE
  • SJD
  • SJS
  • PSO
  • PSA
  • POETYK
  • POETYK-1
  • POETYK-2
  • POETK-SJS
  • jPSA
  • Pediatric
  • Juvenile
  • Deucravacitinib
  • SOTYKTU
03

In context

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

This study's planned enrollment of 2,300 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.

Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,300 participants (estimated)

Study arms

  • Experimental
    Deucravacitinib Arm

    Drug: Deucravacitinib

Interventions

06

What researchers measure

Primary outcomes

  1. Number of participants treated

    Time frame: Up to approximately 28 days after last dose of deucravacitinib

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791199
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Dec 31, 2026 (estimated)
Primary completion
Oct 31, 2030 (estimated)
Completion
Oct 31, 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Deucravacitinib

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