A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
NCT ID: NCT06980805
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2025-02-19
2027-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Period 1: Placebo
Matching placebo for 12 weeks in Period 1
Placebo
Matching Placebo SC QW
IMVT-1402 Subcutaneous (SC) Once weekly (QW)
* Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks
* Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks
* Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks
IMVT-1402
Dose 1 or Dose 2 SC QW
Interventions
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IMVT-1402
Dose 1 or Dose 2 SC QW
Placebo
Matching Placebo SC QW
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1010
Anniston, Alabama, United States
Site Number - 1020
Birmingham, Alabama, United States
Site Number - 1038
Phoenix, Arizona, United States
Site Number - 1034
Scottsdale, Arizona, United States
Site Number - 1022
Beverly Hills, California, United States
Site Number - 1018
Chula Vista, California, United States
Site Number - 1005
Fremont, California, United States
Site Number - 1023
Los Angeles, California, United States
Site Number - 1000
Aurora, Colorado, United States
Site Number - 1033
Castle Rock, Colorado, United States
Site Number - 1021
Farmington, Connecticut, United States
Site Number - 1014
Hialeah, Florida, United States
Site Number - 1028
Miami, Florida, United States
Site Number - 1024
Miami, Florida, United States
Site Number - 1011
Miami Lakes, Florida, United States
Site Number - 1025
Orlando, Florida, United States
Site Number - 1009
Buford, Georgia, United States
Site Number - 1030
Brighton, Massachusetts, United States
Site Number - 1019
Auburn Hills, Michigan, United States
Site Number - 1003
Saint Clair Shores, Michigan, United States
Site Number - 1013
Troy, Michigan, United States
Site Number - 1004
Saint Joseph, Missouri, United States
Site Number - 1007
Charlotte, North Carolina, United States
Site Number - 1008
Durham, North Carolina, United States
Site Number - 1006
Smithfield, North Carolina, United States
Site Number - 1002
Hershey, Pennsylvania, United States
Site Number - 1015
Philadelphia, Pennsylvania, United States
Site Number - 1012
Irving, Texas, United States
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
Site Number - 5600
Sofia, , Bulgaria
Site Number - 5605
Sofia, , Bulgaria
Site Number - 5606
Sofia, , Bulgaria
Site Number - 8002
Tbilisi, , Georgia
Site Number - 8000
Tbilisi, , Georgia
Site Number - 6502
Tübingen, Baden-Wurttemberg, Germany
Site Number - 6500
Erlangen, Bavaria, Germany
Site Number - 6501
Oldenburg, Lower Saxony, Germany
Site Number - 6503
Bochum, North Rhine-Westphalia, Germany
Site Number - 3902
Attiki, Athens, Greece
Site Number - 3901
Athens, Attica, Greece
Site Number - 3903
Thessaloniki, Central Macedonia, Greece
Site Number - 3905
Thessaloniki, Central Macedonia, Greece
Site Number - 3906
Heraklion, Crete, Greece
Site Number - 3900
Attiki, , Greece
Site Number - 3904
Larissa, , Greece
Site Number - 3004
Poznan, Greater Poland Voivodeship, Poland
Site Number - 3005
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
Site Number - 3000
Warsaw, Masovian Voivodeship, Poland
Site Number - 3001
Warsaw, Masovian Voivodeship, Poland
Site Number - 3006
Rzeszów, Pakistan, Poland
Site Number - 3002
Rzeszów, Podkarpackie Voivodeship, Poland
Site Number - 3003
Lodz, , Poland
Site Number-1029
Caguas, , Puerto Rico
Site Number - 1037
Ponce, , Puerto Rico
Site Number - 1036
San Juan, , Puerto Rico
Site Number - 9000
Belgrade, , Serbia
Site Number - 9001
Belgrade, , Serbia
Site Number - 9003
Novi Sad, , Serbia
Site Number - 7104
Badalona, Catalonia, Spain
Site Number - 7105
Pamplona, Navarre, Spain
Site Number - 7101
Burjassot, Valencia, Spain
Site Number - 7100
Madrid, , Spain
Site Number - 7102
Madrid, , Spain
Site Number - 7103
Málaga, , Spain
Site Number - 7000
Liverpool, Merseyside, United Kingdom
Site Number - 7002
Leeds, West Yorkshire, United Kingdom
Site Number - 7003
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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IMVT-1402-2701
Identifier Type: -
Identifier Source: org_study_id