Actively Recruiting
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-11
202
Participants Needed
4
Research Sites
164 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 (ELOWEN-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
- Participants diagnosed with Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE), with or without Systemic Lupus Erythematosus (SLE).
- Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as the only skin manifestation allowed if present at least 6 weeks before Screening and with SLE.
- Participants with SLE meeting EULAR/ACR 2019 classification criteria, having active DLE and/or SCLE and/or ACLE.
- Participants with SLE diagnosis duration of at least 6 months before Screening.
- Participants with a CLASI-A score of 8 or higher at Screening and Day 1 visits.
- Other protocol-defined inclusion criteria may apply.
You will not qualify if you...
- Participants diagnosed primarily with autoimmune rheumatic diseases other than Cutaneous Lupus Erythematosus and SLE (e.g., systemic sclerosis, rheumatoid arthritis).
- Participants with dermatologic diseases other than lupus skin manifestations (e.g., psoriasis), uncontrolled diseases (e.g., asthma, COPD, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening lupus manifestations (e.g., active systemic vasculitis) considered risky.
- Participants with drug-induced lupus (SLE or CLE).
- Participants with active lupus nephritis receiving induction therapy or completed induction therapy within 3 months of Screening (stable maintenance therapy allowed).
- Participants with urine protein-to-creatinine ratio above 339 mg/mmol or estimated glomerular filtration rate below 40 mL/min/1.73 m².
- Participants with active central nervous system lupus symptoms within the past 3 months or history of uncontrolled seizures.
- Other protocol-defined exclusion criteria may apply.
AI-Screening
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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
CONTACT
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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