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
Status: Recruiting
Location: See all (70) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Site Number - 1010
RECRUITING
Anniston
Site Number - 1020
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Birmingham
Arizona
Site Number - 1038
RECRUITING
Phoenix
Site Number - 1034
RECRUITING
Scottsdale
California
Site Number - 1022
RECRUITING
Beverly Hills
Site Number - 1018
RECRUITING
Chula Vista
Site Number - 1005
RECRUITING
Fremont
Site Number - 1023
RECRUITING
Los Angeles
Colorado
Site Number - 1000
RECRUITING
Aurora
Site Number - 1033
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Castle Rock
Connecticut
Site Number - 1021
RECRUITING
Farmington
Florida
Site Number - 1014
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Hialeah
Site Number - 1024
RECRUITING
Miami
Site Number - 1028
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Miami
Site Number - 1011
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Miami Lakes
Site Number - 1025
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Orlando
Georgia
Site Number - 1009
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Buford
Massachusetts
Site Number - 1030
RECRUITING
Brighton
Michigan
Site Number - 1019
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Auburn Hills
Site Number - 1003
RECRUITING
Saint Clair Shores
Site Number - 1013
RECRUITING
Troy
Missouri
Site Number - 1004
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Saint Joseph
North Carolina
Site Number - 1007
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Charlotte
Site Number - 1006
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Smithfield
Pennsylvania
Site Number - 1002
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Hershey
Site Number - 1015
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Philadelphia
Texas
Site Number - 1012
RECRUITING
Irving
Other Locations
Argentina
Site Number - 5000
RECRUITING
Caba
Site Number - 5001
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Caba
Site Number -5004
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Caba
Site Number - 5003
RECRUITING
San Miguel De Tucumán
Bulgaria
Site Number - 5600
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Sofia
Site Number - 5601
RECRUITING
Sofia
Site Number - 5603
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Sofia
Site Number - 5605
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Sofia
Site Number - 5606
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Sofia
Georgia
Site Number - 8000
RECRUITING
Tbilisi
Site Number - 8002
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Tbilisi
Germany
Site Number - 6503
RECRUITING
Bochum
Site Number - 6500
RECRUITING
Erlangen
Site Number - 6501
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Oldenburg
Site Number - 6502
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Tübingen
Greece
Site Number - 3901
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Athens
Site Number - 3900
RECRUITING
Attiki
Site Number - 3902
RECRUITING
Attiki
Site Number - 3906
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Heraklion
Site Number - 3904
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Larissa
Site Number - 3903
RECRUITING
Thessaloniki
Site Number - 3905
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Thessaloniki
Poland
Site Number - 3005
RECRUITING
Gorzów Wielkopolski
Site Number - 3003
RECRUITING
Lodz
Site Number - 3004
RECRUITING
Poznan
Site Number - 3002
RECRUITING
Rzeszów
Site Number - 3006
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Rzeszów
Site Number - 3000
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Warsaw
Site Number - 3001
RECRUITING
Warsaw
Puerto Rico
Site Number-1029
RECRUITING
Caguas
Site Number - 1037
RECRUITING
Ponce
Site Number - 1036
RECRUITING
San Juan
Serbia
Site Number - 9000
RECRUITING
Belgrade
Site Number - 9003
RECRUITING
Novi Sad
Spain
Site Number - 7104
RECRUITING
Badalona
Site Number - 7101
RECRUITING
Burjassot
Site Number - 7100
RECRUITING
Madrid
Site Number - 7102
RECRUITING
Madrid
Site Number - 7103
RECRUITING
Málaga
Site Number - 7105
RECRUITING
Pamplona
United Kingdom
Site Number - 7002
RECRUITING
Leeds
Site Number - 7000
RECRUITING
Liverpool
Site Number - 7003
RECRUITING
London
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
8007970414
Time Frame
Start Date:2025-02-19
Estimated Completion Date:2027-04
Participants
Target number of participants:56
Treatments
Placebo_comparator: Period 1: Placebo
Matching placebo for 12 weeks in Period 1
Experimental: 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