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Clinical Trials in Poland / NCT06980805
Active, not recruiting Phase 2

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 Poland 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-1402 →Placebo

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
No
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)

FacilityCityRegionStatus
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 Poland

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity Active, not recruiting
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis 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
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting

Other trials for the same condition

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
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
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 Poland