Status:
RECRUITING
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The total study duration per participant is approximately 61 weeks.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06980805
Start Date
February 19 2025
End Date
April 1 2027
Last Update
December 26 2025
Active Locations (81)
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1
Site Number - 1010
Anniston, Alabama, United States, 36207-4780
2
Site Number - 1020
Birmingham, Alabama, United States, 35203-4050
3
Site Number - 1038
Phoenix, Arizona, United States, 85037
4
Site Number - 1034
Scottsdale, Arizona, United States, 85260