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A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
NCT06980805 · Immunovant Sciences GmbH
In plain English
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Official title
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
About this study
The total study duration per participant is approximately 61 weeks.
Eligibility 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
Study design
Enrollment target: 56 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-02-19
Estimated completion: 2027-04
Last updated: 2026-03-25
Interventions
Drug: IMVT-1402Drug: Placebo
Primary outcomes
- • 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)
Sponsor
Immunovant Sciences GmbH · industry
Contacts & investigators
ContactCentral Study Contact · contact · clinicaltrials@immunovant.com · 8007970414
All locations (85)
Site Number - 1010Recruiting
Anniston, Alabama, United States
Site Number - 1020Recruiting
Birmingham, Alabama, United States
Site Number - 1038Recruiting
Phoenix, Arizona, United States
Site Number - 1034Recruiting
Scottsdale, Arizona, United States
Site Number - 1022Recruiting
Beverly Hills, California, United States
Site Number - 1018Recruiting
Chula Vista, California, United States
Site Number - 1039Recruiting
Corona, California, United States
Site Number - 1005Recruiting
Fremont, California, United States
Site Number - 1023Recruiting
Los Angeles, California, United States
Site Number - 1000Recruiting
Aurora, Colorado, United States
Site Number - 1033Recruiting
Castle Rock, Colorado, United States
Site Number - 1021Recruiting
Farmington, Connecticut, United States
Site Number - 1014Recruiting
Hialeah, Florida, United States
Site Number - 1017Recruiting
Jacksonville, Florida, United States
Site Number - 1028Recruiting
Miami, Florida, United States
Site Number - 1024Recruiting
Miami, Florida, United States
Site Number - 1027Recruiting
Miami, Florida, United States
Site Number - 1011Recruiting
Miami Lakes, Florida, United States
Site Number - 1025Recruiting
Orlando, Florida, United States
Site Number - 1009Recruiting
Buford, Georgia, United States
Site Number - 1030Recruiting
Brighton, Massachusetts, United States
Site Number - 1019Recruiting
Auburn Hills, Michigan, United States
Site Number - 1003Recruiting
Saint Clair Shores, Michigan, United States
Site Number - 1013Recruiting
Troy, Michigan, United States
Site Number - 1004Recruiting
Saint Joseph, Missouri, United States
Site Number - 1026Recruiting
St Louis, Missouri, United States
Site Number - 1007Recruiting
Charlotte, North Carolina, United States
Site Number - 1008Recruiting
Durham, North Carolina, United States
Site Number - 1006Recruiting
Smithfield, North Carolina, United States
Site Number - 1002Recruiting
Hershey, Pennsylvania, United States
Site Number - 1015Recruiting
Philadelphia, Pennsylvania, United States
Site Number - 1035Recruiting
Houston, Texas, United States
Site Number - 1012Recruiting
Irving, Texas, United States
Site Number -5004Recruiting
CABA, Argentina
Site Number - 5000Recruiting
CABA, Argentina
Site Number - 5001Recruiting
CABA, Argentina
Site Number - 5002Recruiting
San Miguel de Tucumán, Argentina
Site Number - 5003Recruiting
San Miguel de Tucumán, Argentina
Site Number - 5601Recruiting
Sofia, Bulgaria
Site Number - 5603Recruiting
Sofia, Bulgaria
Site Number - 5600Recruiting
Sofia, Bulgaria
Site Number - 5605Recruiting
Sofia, Bulgaria
Site Number - 5606Recruiting
Sofia, Bulgaria
Site Number - 2000Recruiting
Calgary, Alberta, Canada
Site Number - 2003Recruiting
Sarnia, Ontario, Canada
Site Number - 5702Recruiting
Independencia, Chile
Site Number - 5704Recruiting
Santiago, Chile
Site Number - 5703Recruiting
Santiago, Chile
Site Number - 5701Recruiting
Temuco, Chile
Site Number - 5700Recruiting
Victoria, Chile
Site Number - 8002Recruiting
Tbilisi, Georgia
Site Number - 8000Recruiting
Tbilisi, Georgia
Site Number - 6502Recruiting
Tübingen, Baden-Wurttemberg, Germany
Site Number - 6500Recruiting
Erlangen, Bavaria, Germany
Site Number - 6501Recruiting
Oldenburg, Lower Saxony, Germany
Site Number - 6503Recruiting
Bochum, North Rhine-Westphalia, Germany
Site Number - 3902Recruiting
Attiki, Athens, Greece
Site Number - 3901Recruiting
Athens, Attica, Greece
Site Number - 3903Recruiting
Thessaloniki, Central Macedonia, Greece
Site Number - 3905Recruiting
Thessaloniki, Central Macedonia, Greece
Site Number - 3906Recruiting
Heraklion, Crete, Greece
Site Number - 3900Recruiting
Attiki, Greece
Site Number - 3904Recruiting
Larissa, Greece
Site Number - 3004Recruiting
Poznan, Greater Poland Voivodeship, Poland
Site Number - 3005Recruiting
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
Site Number - 3000Recruiting
Warsaw, Masovian Voivodeship, Poland
Site Number - 3001Recruiting
Warsaw, Masovian Voivodeship, Poland
Site Number - 3006Recruiting
Rzeszów, Pakistan, Poland
Site Number - 3002Recruiting
Rzeszów, Podkarpackie Voivodeship, Poland
Site Number - 3003Recruiting
Lodz, Poland
Site Number-1029Recruiting
Caguas, Puerto Rico
Site Number - 1037Recruiting
Ponce, Puerto Rico
Site Number - 1036Recruiting
San Juan, Puerto Rico
Site Number - 9000Recruiting
Belgrade, Serbia
Site Number - 9001Recruiting
Belgrade, Serbia
Site Number - 9003Recruiting
Novi Sad, Serbia
Site Number - 7104Recruiting
Badalona, Catalonia, Spain
Site Number - 7105Recruiting
Pamplona, Navarre, Spain
Site Number - 7101Recruiting
Burjassot, Valencia, Spain
Site Number - 7100Recruiting
Madrid, Spain
Site Number - 7102Recruiting
Madrid, Spain
Site Number - 7103Recruiting
Málaga, Spain
Site Number - 7002Recruiting
Leeds, West Yorkshire, United Kingdom
Site Number - 7003Recruiting
London, United Kingdom
Site Number - 7000Recruiting
Manchester, United Kingdom