Overview
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 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 SC QW for 26 weeks.
Description
The total study duration per participant is up to 67 weeks.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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