Enpatoran for adults with skin lupus, with or without systemic disease
A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)
This 24-week test will see if enpatoran tablets reduce active skin lesions in adults with cutaneous lupus, with or without systemic lupus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | EMD Serono Industry-sponsored |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT07332481 on ClinicalTrials.gov |
What this trial studies
This global, multicenter Phase 3 study gives participants either enpatoran tablets or placebo alongside standard of care for 24 weeks to measure effects on active cutaneous lupus manifestations. Participants are followed for up to 35 weeks with clinic visits every four weeks and a telemedicine contact at Week 2. The trial enrolls adults with documented discoid, subacute, or acute cutaneous lupus, including those with systemic lupus who meet EULAR/ACR 2019 criteria. Safety and skin-specific outcomes will be compared between groups to determine whether TLR7/8 inhibition by enpatoran improves skin disease.
Who should consider this trial
Good fit: Adults with active discoid, subacute, or acute cutaneous lupus (with or without SLE), documented in their medical history and meeting trial entry requirements including up-to-date vaccinations, are the intended participants.
Not a fit: People without active cutaneous lupus lesions, children, pregnant people, or those with medical exclusions for the study drug are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, enpatoran could shrink active skin lesions and reduce flares, improving symptoms and quality of life for people with cutaneous lupus.
How similar studies have performed: TLR7/8 inhibition is a relatively novel approach in lupus with limited published late-phase successes, so this Phase 3 trial is building on earlier-stage work rather than a long track record of proven benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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. Exclusion Criteria * 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.
Where this trial is running
Los Angeles, California and 4 other locations
- Dermatology Research Associates - 300204025 — Los Angeles, California, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Revival Research Institute, LLC — Troy, Michigan, United States (Recruiting)
- Allen Arthritis — Allen, Texas, United States (Recruiting)
- Arthritis and Rheumatology Research Institute PLLC — Allen, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.