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

Launched by IMMUNOVANT SCIENCES GMBH · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMVT-1402 for people with a type of skin condition known as Cutaneous Lupus Erythematosus (CLE). The trial aims to find out how safe and effective this treatment is for participants who have either Subacute or Chronic forms of CLE. If you are between the ages of 65 and 74 and have been diagnosed with CLE that hasn't improved with standard treatments like corticosteroids or certain antimalarials, you may be eligible to participate.

During the trial, participants will go through three different phases. In the first phase, you'll receive either IMVT-1402 or a placebo (a harmless substance that looks like the treatment but has no active ingredients) for 12 weeks. If you complete this phase, you'll continue with IMVT-1402 for another 14 weeks. Finally, in the last phase, you’ll be randomly assigned to receive either a higher or lower dose of IMVT-1402 for 26 weeks. Throughout the study, your health will be closely monitored to assess how well the treatment works and how well you tolerate it. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could help improve treatment options for people with CLE.

Gender

ALL

Eligibility criteria

• 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 of the following as assessed 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