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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT06980805

Run by

Immunovant Sciences GmbH

People needed

56

Starts

2025-02-19

Expected to finish

2027-04-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
• Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
• Have active CLE despite an adequate trial of conventional therapies.
• Are positive for at least one autoantibody at Screening.

You may not qualify if…

• Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
• Have rapidly progressive nephritis.
• Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply

Where it is running

• Site Number - 1020 — Birmingham, Alabama, United States
• Site Number - 1038 — Phoenix, Arizona, United States
• Site Number - 1034 — Scottsdale, Arizona, United States
• Site Number - 1022 — Beverly Hills, California, United States
• Site Number - 1018 — Chula Vista, California, United States
• Site Number - 1039 — Corona, California, United States
• Site Number - 1005 — Fremont, California, United States
• Site Number - 1023 — Los Angeles, California, United States
• Site Number - 1000 — Aurora, Colorado, United States
• Site Number - 1033 — Castle Rock, Colorado, United States
• Site Number - 1021 — Farmington, Connecticut, United States
• Site Number - 1014 — Hialeah, Florida, United States
• Site Number - 1017 — Jacksonville, Florida, United States
• Site Number - 1028 — Miami, Florida, United States
• Site Number - 1024 — Miami, Florida, United States
• Site Number - 1027 — Miami, Florida, United States
• Site Number - 1011 — Miami Lakes, Florida, United States
• Site Number - 1025 — Orlando, Florida, United States
• Site Number - 1009 — Buford, Georgia, United States
• Site Number - 1030 — Brighton, Massachusetts, United States
• Site Number - 1019 — Auburn Hills, Michigan, United States
• Site Number - 1003 — Saint Clair Shores, Michigan, United States
• Site Number - 1013 — Troy, Michigan, United States
• Site Number - 1004 — Saint Joseph, Missouri, United States
• Site Number - 1010 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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