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

NCT ID: NCT06875960

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-29

Study Completion Date

2026-12-01

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Administration of BMS-986165

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986165

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Farmington, Connecticut, United States

Site Status WITHDRAWN

New York University School Of Medicine

New York, New York, United States

Site Status RECRUITING

Local Institution - 0003

Jackson, Tennessee, United States

Site Status WITHDRAWN

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

855-907-3286

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

Role: CONTACT

Facility Contacts

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Amit Saxena, Site 0002

Role: primary

646-501-7387

Related Links

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Other Identifiers

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IM011-1263

Identifier Type: -

Identifier Source: org_study_id

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