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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Period 1: Placebo 		Matching placebo for 12 weeks in Period 1
  • Drug: Placebo
    Matching Placebo SC QW
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
  • Drug: IMVT-1402
    Dose 1 or Dose 2 SC QW

Recruiting Locations

Site Number - 1010
Anniston 4830198, Alabama 4829764 36207-4780

Site Number - 1020
Birmingham 4049979, Alabama 4829764 35203-4050

Site Number - 1038
Phoenix 5308655, Arizona 5551752 85037

Site Number - 1034
Scottsdale 5313457, Arizona 5551752 85260

Site Number - 1022
Beverly Hills 5328041, California 5332921 90211

Site Number - 1018
Chula Vista 5336899, California 5332921 91910

Site Number - 1005
Fremont 5350734, California 5332921 94538

Site Number - 1023
Los Angeles 5368361, California 5332921 90045

Site Number - 1000
Aurora 5412347, Colorado 5417618 80045-2541

Site Number - 1033
Castle Rock 5416329, Colorado 5417618 80109-8034

Site Number - 1021
Farmington 4834272, Connecticut 4831725 06030-2840

Site Number - 1014
Hialeah 4158476, Florida 4155751 33012

Site Number - 1017
Jacksonville 4160021, Florida 4155751 32256

Site Number - 1028
Miami 4164138, Florida 4155751 33122

Site Number - 1024
Miami 4164138, Florida 4155751 33133

Site Number - 1027
Miami 4164138, Florida 4155751 33136

Site Number - 1011
Miami Lakes 4164186, Florida 4155751 33014-5602

Site Number - 1025
Orlando 4167147, Florida 4155751 32819

Site Number - 1009
Buford 4185110, Georgia 4197000 30518-8721

Site Number - 1030
Brighton 4931353, Massachusetts 6254926 02135

Site Number - 1019
Auburn Hills 4984565, Michigan 5001836 48326-3396

Site Number - 1003
Saint Clair Shores 5010978, Michigan 5001836 48081-1274

Site Number - 1013
Troy 5012639, Michigan 5001836 48084 3536

Site Number - 1004
Saint Joseph 4407010, Missouri 4398678 64506-2459

Site Number - 1026
St Louis 4407066, Missouri 4398678 63104

Site Number - 1007
Charlotte 4460243, North Carolina 4482348 28211-1064

Site Number - 1008
Durham 4464368, North Carolina 4482348 27713-8505

Site Number - 1006
Smithfield 4492168, North Carolina 4482348 27577-4664

Site Number - 1002
Hershey 5193342, Pennsylvania 6254927 17033

Site Number - 1015
Philadelphia 4560349, Pennsylvania 6254927 19103-4708

Site Number - 1035
Houston 4699066, Texas 4736286 77030

Site Number - 1012
Irving 4700168, Texas 4736286 75061

Site Number-1029
Caguas 4563008, Puerto Rico 00725-2443

Site Number - 1037
Ponce 4566880, Puerto Rico 00716-0377

Site Number - 1036
San Juan 4568127, Puerto Rico 918

More Details

NCT ID
NCT06980805
Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Central Study Contact
8007970414
clinicaltrials@immunovant.com

Detailed Description

The total study duration per participant is approximately 61 weeks.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center