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

Phase 2

Recruiting

• Conditions: Subacute Cutaneous Lupus Erythematosus; Chronic Cutaneous Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: IMVT-1402

• Registration Number: NCT06980805
• Lead Sponsor: Immunovant Sciences GmbH

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: eligible participants will be randomized 1:1 to IMVT-1402 600 mg or placebo SC QW for 12 weeks.

Period 2: participants who completed Period 1 will receive IMVT-1402 600 mg SC QW for 14 weeks.

Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 600 mg or 300 mg SC QW for 26 weeks.

Detailed Description

The total study duration per participant is up to 67 weeks including:

A screening period of up to 7 weeks.

A treatment period of up to 52 weeks.

A safety follow-up period of up to 8 weeks.

Study Timeline

• Study Start: 2025-02-19
• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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 (defined as either corticosteroids or an antimalarial agent used for at least 12-weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12-weeks OR the requirement to discontinue these agents due to side effects or poor tolerability.

• Are positive for at least one of the following as assessed at Screening:

  1. anti-nuclear antibody (ANA)
  2. elevated anti-double-stranded deoxyribose nucleic acid (DNA)
  3. anti-Sjögren's syndrome-related antigen A antibodies (anti-Ro/SSA)
  4. anti-La/SSB
  5. anti-Smith antibody (anti-Sm)
  6. anti-ribonucleoprotein 70 (anti-RNP70)
  7. positive direct immunofluorescence confirming immunoglobulin (IgG) deposition in a skin biopsy

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Period 1: Placebo	Placebo	Matching placebo for 12 weeks in Period 1
IMVT-1402 600 milligrams (mg) Subcutaneous (SC) Once weekly (QW)	IMVT-1402	* Period 1: IMVT-1402 600 mg SC QW for 12 weeks * Period 2: IMVT-1402 600 mg SC QW for 14 weeks * Period 3: IMVT-1402 600 mg SC QW for 26 weeks
IMVT-1402 300 mg SC QW	IMVT-1402	IMVT-1402 300 mg SC QW for 26 weeks in Period 3

Primary Outcome Measures

Name	Time	Method
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12	Baseline (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.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12	Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12	Baseline (Day 1) and Week 12
Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12	Baseline (Day 1) and Week 12

Trial Locations

Locations (13)

Site Number - 1010; 🇺🇸 Anniston, Alabama, United States

Site Number - 1020; 🇺🇸 Birmingham, Alabama, United States

Site Number - 1018; 🇺🇸 San Diego, California, United States

Site Number - 1014; 🇺🇸 Hialeah, Florida, United States

Site Number - 1011; 🇺🇸 Miami Lakes, Florida, United States

Site Number - 1009; 🇺🇸 Sugar Hill, Georgia, United States

Site Number - 1007; 🇺🇸 Charlotte, North Carolina, United States

Site Number - 1003; 🇺🇸 Saint Clair Shores, Michigan, United States

Site Number - 1004; 🇺🇸 Saint Joseph, Missouri, United States

Site Number - 1006; 🇺🇸 Smithfield, North Carolina, United States

Site Number - 1013; 🇺🇸 Southfield, Michigan, United States

Site Number - 1015; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Number - 1012; 🇺🇸 Grapevine, Texas, United States