Actively Recruiting
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-08
202
Participants Needed
5
Research Sites
167 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo. Intervention Form: Film-coated tablet.
CONDITIONS
Official Title
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Vaccinations are up to date according to local guidelines or recommendations; recombinant zoster vaccination is encouraged but not mandatory
- Diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE), with or without Systemic Lupus Erythematosus (SLE)
- Active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestation allowed if SLE is present and symptoms have lasted at least 6 weeks prior to screening
- Diagnosis of SLE meeting European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, with active DLE and/or SCLE and/or ACLE
- Disease duration of at least 6 months from diagnosis to screening for SLE and cutaneous disease
- Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score of 8 or higher at screening and Day 1
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Primary diagnosis of autoimmune rheumatic diseases other than CLE and SLE, such as systemic sclerosis or rheumatoid arthritis
- Dermatological diseases other than cutaneous lupus manifestations (e.g., psoriasis) or uncontrolled diseases like asthma, COPD, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension
- Life-threatening lupus manifestations such as active systemic vasculitis
- Drug-induced lupus (SLE or CLE)
- Active lupus nephritis on induction therapy or induction therapy completed within 3 months prior to screening; stable maintenance therapy allowed
- Urine Protein-to-Creatinine Ratio greater than 339 mg/mmol or estimated Glomerular Filtration Rate less than 40 mL/min/1.73 m²
- Active central nervous system lupus signs, symptoms, or diagnoses within the past 3 months, or history of uncontrolled seizures
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Dermatology Research Associates - 300204025
Los Angeles, California, United States, 90045
Actively Recruiting
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Actively Recruiting
3
Revival Research Institute, LLC
Troy, Michigan, United States, 48084
Actively Recruiting
4
Allen Arthritis
Allen, Texas, United States, 75013
Actively Recruiting
5
Arthritis and Rheumatology Research Institute PLLC
Allen, Texas, United States, 75013
Actively Recruiting
Research Team
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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