Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-08
202
Participants Needed
5
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 effectiveness and safety of enpatoran in adults with active skin symptoms of lupus erythematosus, with or without systemic disease. This global, multicenter Phase 3 study aims to understand how well enpatoran works over 24 weeks compared to a placebo, while participants continue their standard care for lupus. The study is sponsored by EMD Serono Research & Development Institute, Inc. Participants will be randomly assigned to receive either enpatoran tablets or placebo tablets taken orally twice daily from Day 1 through Day 168. The study treatment lasts 24 weeks, with visits scheduled every 4 weeks, except for a Week 2 telemedicine visit. Standard of care treatment will be provided alongside the study medication during this period. During the study, participants will have regular visits to assess their skin lupus disease activity using the CLASI score and other lupus activity measures. Researchers will monitor safety by tracking adverse events and laboratory tests. The main outcome is the percentage of participants achieving a 70% improvement in their skin lupus severity after 24 weeks. Overall participation can last up to 35 weeks, including screening and follow-up assessments.
CONDITIONS
Brief 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; recombinant zoster vaccination is encouraged but not required
- 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 skin manifestation allowed if present for at least 6 weeks before screening and in presence of SLE
- Diagnosis of SLE meeting EULAR/ACR 2019 criteria with active DLE, SCLE, and/or ACLE
- Disease duration of 6 months or more from diagnosis to screening
- CLASI-A score of 8 or higher at screening and Day 1 visits
- Aged between 18 and 75 years
You will not qualify if you...
- Primary 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 like active systemic vasculitis
- Drug-induced lupus (SLE or CLE)
- Active lupus nephritis on induction therapy or completed within 3 months before screening (stable maintenance therapy allowed)
- Urine Protein-to-Creatinine Ratio greater than 339 mg/mmol or eGFR less than 40 mL/min/1.73 m2
- Active central nervous system lupus signs or uncontrolled seizures within past 3 months
- Other exclusion criteria as defined by protocol
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 - 168 days
Participants receive Enpatoran or placebo orally twice daily along with standard of care from Day 1 to Day 168.
Multiple visits during treatment period as per study schedule
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
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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