Authorised Therapeutic exploratory (Phase II) Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

A Phase 2 Clinical Study to Assess the Safety and Efficacy of Deucravacitinib in Participants with Active DLE and/or SCLE

EU CTIS ID: 2023-504161-22-00

What this study is testing

To evaluate the effect of two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo on CLASI-A score at Week 16

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participants must have a diagnosis of DLE/SCLE
  • Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (CLASI-A) score ≥ 8
  • Participants must currently be receiving stable treatment regimen for CLE
  • For optional long term extension treatment period: Completion of Study IM011132 through the protocol-required active treatment period (ie up to and including week 52 treatment visit).
  • For optional long-term extension treatment period: Participant is, based on the invesigators medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.

You likely can't join if

  • Participants with forms of drug-induced CLE and/or drug-induced SLE
  • Participants with other non-SLE driven inflammatory conditions that will significantly impact the assessment of CLE/SLE disease manifestations and activity

The study team makes the final eligibility decision.

Where it's taking place

  • Canada
  • Australia
  • Argentina
  • United States
  • United Kingdom
  • Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Canada; Australia; Argentina; United States; United Kingdom; Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.