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A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

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 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 SC QW for 26 weeks.

Conditions

Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: 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 of the following as assessed 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

Arm	Description	Assigned 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 SC QW for 12 weeks - Period 2: IMVT-1402 SC QW for 14 weeks - Period 3: IMVT-1402 SC QW for 26 weeks	Drug: IMVT-1402 SC QW

Recruiting Locations

Site Number - 1010
Anniston, Alabama 36207

Site Number - 1020
Birmingham, Alabama 35203

Site Number - 1018
San Diego, California 92108

Site Number - 1014
Hialeah, Florida 33012

Site Number - 1011
Miami Lakes, Florida 33014

Site Number - 1009
Sugar Hill, Georgia 30518

Site Number - 1003
Saint Clair Shores, Michigan 48081

Site Number - 1013
Southfield, Michigan 48034

Site Number - 1004
Saint Joseph, Missouri 64506

Site Number - 1007
Charlotte, North Carolina 28211

Site Number - 1006
Smithfield, North Carolina 27577

Site Number - 1015
Philadelphia, Pennsylvania 19013

Site Number - 1012
Grapevine, Texas 76051

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 up to 67 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.