A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

NCT06875960 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IM011-1263
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132

Conditions

Systemic Lupus Erythematosus (SLE); Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Outcome Measures

Primary Outcomes (1)

• Number of participants treated with BMS-986165

  Up to 2 years

Study Arms (1)

Administration of BMS-986165

EXPERIMENTAL

Drug: BMS-986165

Interventions

BMS-986165 DRUG

Specified dose on specified days

Administration of BMS-986165

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period.
• Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.
• Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.

You may not qualify if:

• Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason.
• Participants must not have any evidence of active Tuberculosis (TB).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Local Institution - 0001

Farmington, Connecticut, 06030, United States

WITHDRAWN

New York University School Of Medicine

New York, New York, 10155, United States

RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Local Institution - 0003

Jackson, Tennessee, 38305, United States

WITHDRAWN

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 14, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (4)