RightFit
RecruitingPhase 3

A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

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-2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 35 weeks
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study details include: Study Duration: Up to 35 weeks."
  • "Intervention Form: Film-coated tablet."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well enpatoran works and how safe it is for people with active lupus skin problems, with or without lupus affecting other parts of the body. It compares enpatoran tablets with placebo tablets over 24 weeks. The study lasts up to 35 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your vaccines must be up to date under local guidelines. The recommended shingles vaccine is encouraged but not required.
  • Your medical record must show discoid lupus or subacute cutaneous lupus, two forms of skin lupus, with or without systemic lupus, which can affect other parts of the body.
  • If acute cutaneous lupus is your only form of skin lupus, you must also have systemic lupus. These skin problems must be present for at least 6 weeks before screening.
  • If you have systemic lupus, you must meet the 2019 EULAR/ACR rules for classifying it and have active lupus skin problems.
  • For people with systemic lupus: skin lupus and systemic lupus must have been diagnosed at least 6 months before screening.
  • For people with systemic lupus: your CLASI-A score, which measures skin lupus activity, must be at least 8 at screening and on Day 1.
  • Other study rules may apply.

Who can't join

  • Your main diagnosis is another disease in which the immune system attacks the body, such as rheumatoid arthritis or systemic sclerosis.
  • You have another skin condition, an uncontrolled illness, or life-threatening lupus problems that the study team believes make joining unsafe.
  • Your lupus was caused by a medicine.
  • You have active lupus kidney disease and are getting its starting treatment, or finished that treatment within 3 months before screening. Stable ongoing treatment with certain medicines is allowed.
  • Your urine protein-to-creatinine ratio, a test of protein in urine, is above 339 mg/mmol, or your eGFR, a measure of kidney filtering, is below 40 mL/min/1.73 m².
  • You have had signs, symptoms, or a diagnosis of lupus affecting the brain or spinal cord in the past 3 months, or have ever had uncontrolled seizures.
  • Other study rules may apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (14)

CA

FL

IN

LA

MI

NC

TX