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Recruiting NCT06875960

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986165.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus (SLE), Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

Overview

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

Interventions

  • Drug BMS-986165
    Specified dose on specified days

Primary outcome measures

  • Number of participants treated with BMS-986165 [Time frame: Up to 2 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Local Institution - 0001 — Farmington
  • New York University School Of Medicine — New York
  • Oklahoma Medical Research Foundation — Oklahoma City
  • Local Institution - 0003 — Jackson

Identifiers

NCT: NCT06875960 · IM011-1263

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗