Evaluation of IMVT-1402 Efficacy and Safety in Active Subacute and Chronic Cutaneous Lupus Erythematosus: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate the **efficacy** of IMVT-1402 compared to placebo in participants with **cutaneous lupus erythematosus** (CLE), as assessed by changes in the CLASI-A score. This objective is clinically relevant as it aims to determine the potential therapeutic benefit of IMVT-1402 in improving skin manifestations associated with CLE, which can significantly impact patients' quality of life.

Secondary objectives include evaluating the efficacy of IMVT-1402 compared to placebo in participants with CLE, as assessed by improvements in the CLASI-A score. This further assessment will provide additional insights into the therapeutic potential of IMVT-1402 in managing CLE symptoms.

The clinical trial involves a total of **10 participants** diagnosed with **cutaneous lupus erythematosus** (CLE). The study population includes both male and female subjects, with an age range that spans from **18 to 65 years**. Participants were selected based on specific criteria, including a documented diagnosis of subacute cutaneous lupus erythematosus (SCLE) or chronic cutaneous lupus erythematosus (CCLE) confirmed by biopsy, and a CLASI-A score of 10 or higher at screening and on Day 1. The trial does not include a vulnerable population. Participants are required to have active CLE despite an adequate trial of conventional therapies or a documented failure to respond to these agents. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The selection process ensures that participants have a positive result for at least one specific autoantibody or a positive direct immunofluorescence confirming IgG deposition in a skin biopsy.

The clinical trial is a **Phase 2b**, randomized, double-blind, placebo-controlled study designed 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. The trial aims to evaluate the efficacy of IMVT-1402 compared to placebo by measuring changes in the CLASI-A score. The study is expected to commence recruitment on July 31, 2025, and conclude by April 1, 2027, with a maximum treatment period of 52 weeks.

Participants will be randomly assigned to receive either IMVT-1402 or a placebo, both administered as a **solution for injection** via the subcutaneous route. The trial will include several key visits: an initial screening visit to confirm eligibility based on criteria such as a documented diagnosis of SCLE or CCLE and a CLASI-A score of ≥10, followed by regular follow-up visits to monitor safety and efficacy. The primary endpoint is the percent change from baseline in the CLASI-A score at Week 12, with secondary endpoints including the proportion of participants achieving significant reductions in the CLASI-A score.

The expected length of participant involvement is up to 52 weeks, with conditions for early termination including adverse events, withdrawal of consent, or non-compliance with the study protocol. Participants must have active cutaneous lupus erythematosus despite prior conventional therapies or documented failure to respond to such treatments. The study will ensure rigorous monitoring to maintain the integrity of the double-blind design, with neither participants nor investigators aware of the treatment assignments.

The clinical trial involves the administration of **IMVT-1402**, an investigational medicinal product developed by Immunovant Sciences GmbH. IMVT-1402 is formulated as a **solution for injection** and is administered via the **subcutaneous** route. The maximum daily dose of IMVT-1402 is 600 mg, with a total maximum dose of 31,200 mg over a treatment period of up to 52 weeks. The active substance in IMVT-1402 is a protein of other origin, specifically designed for this study. The administration schedule and participant compliance are closely monitored to ensure adherence to the dosing regimen.

The study also includes a **placebo** group, which receives an injection identical in appearance to the investigational product but contains no active substance. The placebo is used to maintain the double-blind nature of the trial, ensuring that neither the participants nor the investigators are aware of the treatment assignments. The placebo is administered following the same route and schedule as IMVT-1402 to provide a valid comparison for assessing the efficacy and safety of the investigational product.

The efficacy of IMVT-1402 in the clinical trial will be assessed by evaluating changes in the **Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity** (CLASI-A) score. The primary endpoint is the percent change from the baseline in the CLASI-A score at Week 12. Secondary endpoints include the proportion of participants who achieve a reduction in the CLASI-A score of at least 5 points, 50%, and 70% from the baseline at Week 12. These assessments will be conducted using validated scales to ensure accuracy and reliability in measuring the efficacy of the treatment.