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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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 4

Conditions

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

Treatments

Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

NCT06875960
IM011-1263

Details and patient eligibility

About

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

Enrollment

35 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Administration of BMS-986165
Experimental group
Treatment:
Drug: BMS-986165

Trial contacts and locations

3

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Central trial contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; First line of the email MUST contain the NCT# and Site#

Data sourced from clinicaltrials.gov

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