Last updated 14 days ago
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
202 patients around the world
Available in Brazil, United States
EMD Serono Research & Development Institute, Inc.
5Research sites
202Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Cutaneous lupus erythematosus
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.For participants with SLE.Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.Participants with disease duration (cutaneous disease and, where applicable, SLE) of >= 6 months from time of diagnosis to Screening.Participants with CLASI-A score >= 8 at Screening and Day 1 visits.Other protocol-defined inclusion criteria may apply.
- Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.Participants with drug-induced lupus (SLE or CLE).Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.Other protocol-defined exclusion criteria may apply.
Sites
Hospital Universitário Walter Cantídio - Universidade Federal do Ceará - Fortaleza, Ceara
Recruiting
SER da Bahia - Serviços Especializados em Reumatologia
Recruiting
IPC - Instituto de Pesquisa Clinica de Mato Grosso
Recruiting
Freire Pesquisa Clínica
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII (Hospital de AMOR)
Recruiting
StudyELOWEN-1
SponsorEMD Serono Research & Development Institute, Inc.
Study typeInterventional
Conditions
Systemic lupus erythematosusCutaneous lupus erythematosus
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07332481
