NCT06980805
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentImmunovant Sciences GmbH
~56 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IMVT-1402Placebo
At a glance
Recruiting sites
0 of 86 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
Measured over Baseline (Day 1) and Week 12
Conditions
Where it's being run
86 sites across 42 statesFlorida7
California5
Argentina5
Bulgaria5
Chile5
Georgia3
Michigan3
North Carolina3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.
What this trial measures
- Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12Baseline (Day 1) and Week 12
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.