A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
Sponsor: Immunovant Sciences GmbH
This observational or N/A phase trial investigates Chronic Cutaneous Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus and is currently actively recruiting participants. Immunovant Sciences GmbH leads this study, which shows 8 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)The total study duration per participant is approximately 61 weeks.
The total study duration per participant is approximately 61 weeks.
Status Flow
Change History
8 versions recorded-
Apr 21, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE2
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE2
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE2
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Oct 2025 — Dec 2025 [monthly]
Recruiting PHASE2
▶ Show 3 earlier versions
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Aug 2025 — Oct 2025 [monthly]
Recruiting PHASE2
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE2
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE2
First recorded
Feb 2025
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- Immunovant Sciences GmbH
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Anniston, United States , Athens, Greece , Attiki, Greece , Attiki, Greece , Auburn Hills, United States , Aurora, United States , Badalona, Spain , Belgrade, Serbia , Belgrade, Serbia , Beverly Hills, United States and 76 more locations