Clinical Trial

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

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-27
notable Primary completion moved earlier: 2027-04 -> 2026-10 2026-05-27
Trial Details
NCT Number NCT06980805
Lead Sponsor Immunovant Sciences GmbH
Conditions Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Enrollment 56 participants
Start Date 2025-02-19
Primary Completion 2026-10 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-10