NCT07791199

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for phase_3

Timeline
51mo left

Started Sep 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 2, 2026

Expected
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4.2 years

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

SLESJDSJSPSOPSAPOETYKPOETYK-1POETYK-2POETK-SJSjPSAPediatricJuvenileDeucravacitinibSOTYKTU

Outcome Measures

Primary Outcomes (1)

  • Number of participants treated

    Up to approximately 28 days after last dose of deucravacitinib

Study Arms (1)

Deucravacitinib Arm

EXPERIMENTAL
Drug: Deucravacitinib

Interventions

Specified dose on specified days

Deucravacitinib Arm

Eligibility Criteria

Age4 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, SystemicSjogren's SyndromePsoriasisArthritis, Psoriatic

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesSkin Diseases, PapulosquamousSkin DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start (Estimated)

September 2, 2026

Primary Completion (Estimated)

October 31, 2030

Study Completion (Estimated)

October 31, 2030

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information