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NCT04857034 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 2
Development phase
74
Enrollment target
20
Study locations

NCT04857034: Active Phase 2 study of Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous, sponsored by Bristol-Myers Squibb.

NCT04857034 is a Phase 2 study of Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 74 participants, above the 51-participant average among 3 other Lupus Erythematosus, Discoid trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04857034, a Phase 2 study of Lupus Erythematosus, Discoid and Lupus Erythematosus, Subacute Cutaneous, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
74 participants
Enrollment target
20
Study locations

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.

Primary Outcome

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

Conditions Studied

Lupus Erythematosus, Discoid Lupus Erythematosus, Subacute Cutaneous

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
Bristol-Myers Squibb

1,025 total trials

What the registry record for NCT04857034 still lists

NCT04857034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 51-participant average among 3 other Lupus Erythematosus, Discoid trials with a reported enrollment target (45% higher).

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.

NCT04857034 names 20 study sites across 16 states, led by Victoria, California, New South Wales.

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.

What interventions are being tested in trial NCT04857034?

The interventions under investigation include: Placebo (DRUG), Deucravacitinib (DRUG).

Who is sponsoring clinical trial NCT04857034?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

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.

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Related registry views

Source: ClinicalTrials.gov NCT04857034, the US trial registry maintained by the National Library of Medicine. NCT04857034 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.