Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Sponsor: Immunovant Sciences GmbH
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-02-19
Completion Date
2027-04
Last Updated
2026-03-25
Healthy Volunteers
No
Interventions
IMVT-1402
Dose 1 or Dose 2 SC QW
Placebo
Matching Placebo SC QW
Locations (85)
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 - 1039
Corona, 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 - 1017
Jacksonville, Florida, United States
Site Number - 1028
Miami, Florida, United States
Site Number - 1024
Miami, Florida, United States
Site Number - 1027
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 - 1026
St Louis, 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 - 1035
Houston, Texas, 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 - 2000
Calgary, Alberta, Canada
Site Number - 2003
Sarnia, Ontario, Canada
Site Number - 5702
Independencia, Chile
Site Number - 5704
Santiago, Chile
Site Number - 5703
Santiago, Chile
Site Number - 5701
Temuco, Chile
Site Number - 5700
Victoria, Chile
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 - 7002
Leeds, West Yorkshire, United Kingdom
Site Number - 7003
London, United Kingdom
Site Number - 7000
Manchester, United Kingdom