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

NCT06980805 · tracked via the Priya Life Science UK tracker

Sponsor

Immunovant Sciences GmbH

Phase

Phase 2

Started

2025-02-19

Last updated

2026-08-28

Condition(s) studied

Subacute Cutaneous Lupus ErythematosusChronic Cutaneous Lupus Erythematosus

Investigational drug(s) / intervention(s)

IMVT-1402Placebo

IMVT-1402: Dose 1 or Dose 2 SC QW

Placebo: Matching Placebo SC QW

Study 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 Dose 1 or placebo SC QW for 12 weeks.

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

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (86)

Facility	City	Region
Site Number - 1010	Anniston	Alabama
Site Number - 1020	Birmingham	Alabama
Site Number - 1038	Phoenix	Arizona
Site Number - 1034	Scottsdale	Arizona
Site Number - 1022	Beverly Hills	California
Site Number - 1018	Chula Vista	California
Site Number - 1039	Corona	California
Site Number - 1005	Fremont	California
Site Number - 1023	Los Angeles	California
Site Number - 1000	Aurora	Colorado
Site Number - 1033	Castle Rock	Colorado
Site Number - 1021	Farmington	Connecticut
Site Number - 1014	Hialeah	Florida
Site Number - 1017	Jacksonville	Florida
Site Number - 1028	Miami	Florida
Site Number - 1024	Miami	Florida
Site Number - 1027	Miami	Florida
Site Number - 1011	Miami Lakes	Florida
Site Number - 1025	Orlando	Florida
Site Number - 1009	Buford	Georgia
Site Number - 1030	Brighton	Massachusetts
Site Number - 1019	Auburn Hills	Michigan
Site Number - 1003	Saint Clair Shores	Michigan
Site Number - 1013	Troy	Michigan
Site Number - 1004	Saint Joseph	Missouri
Site Number - 1026	St Louis	Missouri
Site Number - 1007	Charlotte	North Carolina
Site Number - 1008	Durham	North Carolina
Site Number - 1006	Smithfield	North Carolina
Site Number - 1002	Hershey	Pennsylvania
Site Number - 1015	Philadelphia	Pennsylvania
Site Number - 1035	Houston	Texas
Site Number - 1012	Irving	Texas
Site Number -5004	CABA	Argentina
Site Number - 5000	CABA	Argentina
Site Number - 5001	CABA	Argentina
Site Number - 5002	San Miguel de Tucumán	Argentina
Site Number - 5003	San Miguel de Tucumán	Argentina
Site Number - 5601	Sofia	Bulgaria
Site Number - 5603	Sofia	Bulgaria

+ 46 more sites — see the full list on the official registry below.

More Immunovant Sciences GmbH trials in the UK

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis Recruiting

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Active, not recruiting

Other trials for the same condition

A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus Active, not recruiting

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980805 on ClinicalTrials.gov ↗ ← All trials in the UK