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
Immunovant Sciences GmbH
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.
Description
The total study duration per participant is approximately 61 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 pr…
Interventions
- DrugIMVT-1402
Dose 1 or Dose 2 SC QW
- DrugPlacebo
Matching Placebo SC QW
Locations (86)
- Site Number - 1010Anniston, Alabama
- Site Number - 1020Birmingham, Alabama
- Site Number - 1038Phoenix, Arizona
- Site Number - 1034Scottsdale, Arizona
- Site Number - 1022Beverly Hills, California
- Site Number - 1018Chula Vista, California