Last updated 3 days ago
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
56 patients around the world
Available in Puerto Rico, Argentina, United States
The total study duration per participant is approximately 61 weeks.
Immunovant Sciences GmbH
5Research sites
56Patients around the world
This study is for people with
Lupus
Cutaneous lupus erythematosus
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
Sites
Centro de Investigaciones Médicas Tucumán
Recruiting
STAT Research - CABA
Recruiting
Clínica Mayo de UMCB SRL
Recruiting
Aprillus Asistencia e Investigación
Recruiting
Swiss Medical Center Barrio Parque - CABA
Recruiting
SponsorImmunovant Sciences GmbH
Study typeInterventional
Conditions
Cutaneous lupus erythematosus
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06980805
