RECRUITING

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

Conditions

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus IMVT-1402

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-02-19

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06980805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Central Study Contact

CONTACT

8007970414

clinicaltrials@immunovant.com

Study Locations (Sites)

Site Number - 1010

Anniston, Alabama, 36207-4780

United States

Site Number - 1020

Birmingham, Alabama, 35203-4050

United States

Site Number - 1038

Phoenix, Arizona, 85037

United States

Site Number - 1022

Beverly Hills, California, 90211

United States

Site Number - 1018

Chula Vista, California, 91910

United States

Site Number - 1005

Fremont, California, 94538

United States

Site Number - 1023

Los Angeles, California, 90045

United States

Site Number - 1000

Aurora, Colorado, 80045-2541

United States

Site Number - 1033

Castle Rock, Colorado, 80109-8034

United States

Site Number - 1021

Farmington, Connecticut, 06030-2840

United States

Site Number - 1014

Hialeah, Florida, 33012

United States

Site Number - 1028

Miami, Florida, 33122

United States

Site Number - 1024

Miami, Florida, 33133

United States

Site Number - 1011

Miami Lakes, Florida, 33014-5602

United States

Site Number - 1025

Orlando, Florida, 32819

United States

Site Number - 1009

Buford, Georgia, 30518-8721

United States

Site Number - 1030

Brighton, Massachusetts, 02135

United States

Site Number - 1019

Auburn Hills, Michigan, 48326-3396

United States

Site Number - 1003

Saint Clair Shores, Michigan, 48081-1274

United States

Site Number - 1013

Troy, Michigan, 48084 3536

United States

Site Number - 1004

Saint Joseph, Missouri, 64506-2459

United States

Site Number - 1007

Charlotte, North Carolina, 28211-1064

United States

Site Number - 1006

Smithfield, North Carolina, 27577-4664

United States

Site Number - 1015

Philadelphia, Pennsylvania, 19103-4708

United States

Site Number - 1012

Irving, Texas, 75061

United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-19

Study Completion Date2027-04

Study Record Updates

Study Start Date2025-02-19

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Chronic Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus
IMVT-1402

Additional Relevant MeSH Terms

Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus