Enpatoran for cutaneous lupus with or without systemic disease (ELOWEN-2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multicenter Phase 3 trial compares oral enpatoran to placebo alongside standard-of-care in adults with active cutaneous lupus manifestations. Participants take film-coated enpatoran tablets or matching placebo for 24 weeks, attend clinic visits every four weeks with a Week 2 televisit, and are followed for up to 35 weeks in total. Eligible participants have documented discoid, subacute, or acute cutaneous lupus (ACLE allowed if present ≥6 weeks and, when applicable, in the setting of SLE) and meet local vaccination guidance. Safety data and measures of skin response will be collected throughout treatment to determine whether enpatoran provides superior benefit to placebo.

Why it matters

Who can join: the full rules

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 it's running

• Inland Rheumatology Clinical Trials, Inc.
  Upland, California, United States Recruiting
• Omega Research Debary, LLC
  DeBary, Florida, United States Recruiting
• Centre for Rheumatology, Immunology and Arthritis
  Fort Lauderdale, Florida, United States Recruiting
• South Florida Rheumatology
  Hollywood, Florida, United States Recruiting
• GTL Medical And Research Group
  Miami, Florida, United States Recruiting
• Bolanos Clinical Research
  Pembroke Pines, Florida, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.