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Assessing a new treatment for skin lupus

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

PHASE2 · Immunovant Sciences GmbH · NCT06980805

This study is testing a new treatment called IMVT-1402 to see if it can help people with skin lupus feel better and manage their symptoms.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment56 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH (industry)
Locations86 sites (Anniston, Alabama and 85 other locations)
Trial IDNCT06980805 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and efficacy of IMVT-1402 in participants diagnosed with Cutaneous Lupus Erythematosus (CLE). It consists of three periods: an initial 12-week randomized phase comparing IMVT-1402 to a placebo, followed by a 14-week treatment phase with IMVT-1402 for all participants, and a final 26-week phase where participants are re-randomized to receive either 600 mg or 300 mg of IMVT-1402. The total duration for each participant can be up to 67 weeks, including screening, treatment, and safety follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are individuals with a confirmed diagnosis of subacute or chronic cutaneous lupus erythematosus who have not responded adequately to conventional therapies.

Not a fit: Patients who do not have a documented diagnosis of cutaneous lupus erythematosus or those who have not previously tried conventional therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from Cutaneous Lupus Erythematosus.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Anniston, Alabama and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus, IMVT-1402, Imeroprubart

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.