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

Last updated: June 4, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Lupus Erythematosus

Lupus

Cutaneous Lupus Erythematosus

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT06980805
IMVT-1402-2701
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with orwithout systemic LE manifestations.

  • Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with aCLASI-A score of ≥8 and <10 are eligible if the score does not include alopeciaand/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

Exclusion Criteria:

  • Have known or suspected drug-induced CLE anti-phospholipid disease, orneuropsychiatric SLE.

  • Have rapidly progressive nephritis.

  • Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion ofthe Investigator, could interfere with the inflammatory skin assessments or confoundthe disease activity assessments.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 19, 2025
Estimated Completion Date:
April 30, 2027

Study Description

The total study duration per participant is up to 67 weeks.

Connect with a study center

  • Site Number - 1010

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Site Number - 1020

    Birmingham, Alabama 35203
    United States

    Active - Recruiting

  • Site Number - 1018

    San Diego, California 92108
    United States

    Active - Recruiting

  • Site Number - 1014

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Site Number - 1011

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Site Number - 1009

    Sugar Hill, Georgia 30518
    United States

    Active - Recruiting

  • Site Number - 1003

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Site Number - 1013

    Southfield, Michigan 48034
    United States

    Active - Recruiting

  • Site Number - 1004

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Site Number - 1007

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Site Number - 1006

    Smithfield, North Carolina 27577
    United States

    Active - Recruiting

  • Site Number - 1015

    Philadelphia, Pennsylvania 19013
    United States

    Active - Recruiting

  • Site Number - 1012

    Grapevine, Texas 76051
    United States

    Active - Recruiting

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