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ACTIVE NOT RECRUITING Phase 2

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

NCT04857034 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.

Interventions

  • DRUG Placebo
  • DRUG Deucravacitinib

Study Locations (20)

Victoria

  • Local Institution - 0002 — Camberwell
  • Local Institution - 0007 — Clayton
  • Local Institution - 0078 — Melbourne

California

  • Local Institution - 0076 — Irvine
  • Local Institution - 0046 — Los Angeles

New South Wales

  • Local Institution - 0003 — Botany
  • Local Institution - 0001 — Kogarah

Arizona

  • Local Institution - 0077 — Scottsdale

Connecticut

  • Local Institution - 0073 — Farmington

Florida

  • Local Institution - 0082 — Orlando

Michigan

  • Local Institution - 0060 — Ann Arbor

Missouri

  • Local Institution - 0059 — St Louis

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2021-07-12
Est. Completion 2028-02-28
Phase Phase 2

Sponsor

Bristol-Myers Squibb

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04857034

The ClinicalTrials.gov registry entry for NCT04857034 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Lupus Erythematosus, Discoid appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04857034 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Victoria, California, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04857034 about?

NCT04857034 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)". The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and ...

What is the current status of trial NCT04857034?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2021-07-12. Estimated completion is 2028-02-28.

What conditions does trial NCT04857034 study?

This clinical trial studies the following conditions: Lupus Erythematosus, Discoid, Lupus Erythematosus, Subacute Cutaneous. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04857034?

The interventions under investigation include: Placebo (DRUG), Deucravacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04857034?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04857034 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial