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A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. 3 versions Re-verified since Jun 15, 2026, no change to tracked fieldsv13-v15
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Apr 2027 to Oct 2026
    • Site details revised at 86 of 86 sites
    v12
  3. Study sites: 85 to 86v11
  4. Study sites: 84 to 85v10
  5. Study sites: 82 to 84v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 81 to 82v8
  2. Study sites: 73 to 81v7
  3. Study sites: 70 to 73v6
  4. Study sites: 56 to 70v5
  5. Study sites: 13 to 56
    • Study description shortened, about 1 word
    v4
  6. Eligibility criteria shortened, about 4 wordsv3
  7. Interventions: IMVT-1402 (Drug), IMVT-1402 (Drug), Placebo (Drug) to IMVT-1402 (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 78 words
    • Study description shortened, about 26 words
    • Study arms: 3 to 2
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
Trial Details
NCT Number NCT06980805
Lead Sponsor Immunovant Sciences GmbH
Conditions
(from sponsor)		 Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Related terms Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov