Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Enpatoran for Active Cutaneous Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-11
202
Participants Needed
4
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of Enpatoran in adults with active skin symptoms of lupus erythematosus, including those with or without systemic disease. This global, multicenter Phase 3 study aims to better understand how Enpatoran affects the severity of cutaneous lupus over 24 weeks of treatment. The study is sponsored by EMD Serono Research & Development Institute, Inc., and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either Enpatoran or a matching placebo, taken orally twice daily for 24 weeks, alongside standard care recommended by their investigators. The study includes regular visits every 4 weeks, with one televisit at Week 2. The study medication is in the form of film-coated tablets. The total study duration can last up to 35 weeks, including treatment and follow-up. During the study, participants will undergo assessments of their skin disease severity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and other lupus activity measures. Researchers will monitor adverse events, changes in laboratory tests, and symptom changes such as itch severity and skin inflammation. The main outcome measured is the percentage of participants achieving at least a 70% improvement in cutaneous lupus symptoms at Week 24. Safety and tolerability will also be carefully observed throughout the study period.
CONDITIONS
Brief Title
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Vaccinations are up to date according to local guidelines; recombinant zoster vaccination is encouraged but not mandatory
- Diagnosis of Discoid Lupus Erythematosus and/or Subacute Cutaneous Lupus Erythematosus with or without Systemic Lupus Erythematosus
- Active Acute Cutaneous Lupus Erythematosus present for at least 6 weeks prior to screening if sole cutaneous manifestation with SLE
- Diagnosis of Systemic Lupus Erythematosus fulfilling EULAR/ACR 2019 criteria with active DLE, SCLE, or ACLE
- Disease duration of at least 6 months from diagnosis to screening for participants with SLE
- 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...
- Diagnosis of autoimmune rheumatic diseases other than CLE and SLE (e.g., systemic sclerosis, rheumatoid arthritis)
- Presence of dermatological diseases other than lupus skin manifestations (e.g., psoriasis)
- Uncontrolled diseases such as asthma, COPD, interstitial lung disease, bronchiectasis, or 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
- Urine Protein-to-Creatinine Ratio greater than 339 mg/mmol or estimated Glomerular Filtration Rate below 40 mL/min/1.73 m²
- Active central nervous system lupus signs or symptoms within past 3 months or history of uncontrolled seizures
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (168 days)
Participants receive oral doses of Enpatoran or placebo twice daily along with standard of care for active cutaneous lupus erythematosus.
Regular visits during treatment period
Trial Site Locations
Total: 4 locations
1
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States, 91786
Actively Recruiting
2
Omega Research Debary, LLC
DeBary, Florida, United States, 32713
Actively Recruiting
3
Bolanos Clinical Research
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
4
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
Research Team
U
US Medical Information
C
Communication Center
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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