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Recruiting NCT07355218

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

Phase III Interventional Systematic Lupus Erythematosus Cutaneous Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enpatoran, Placebo, Standard of care (SoC).
Who it may be relevant to
Registry conditions: Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Drug Enpatoran
    Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
  • Drug Placebo
    Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.
  • Drug Standard of care (SoC)
    Participants will receive Investigator-recommended SoC.

Primary outcome measures

  • Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline [Time frame: At Week 24]
Secondary outcome measures (12)
  • Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response [Time frame: At Week 24]
  • Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [Time frame: From Day 1 to Week 24]
  • Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [Time frame: From Day 1 to Week 24]
  • Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24 [Time frame: At Week 24]
  • Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline [Time frame: At Weeks 4 and 24]
  • Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [Time frame: Day 1 up to Week 12 and thereafter upto Week 24]
  • Change from Baseline in Worst Itch Numeric Rating Scale (NRS) Score at Week 24 [Time frame: Baseline and at Week 24]
  • Change from Baseline in CLASI-A Erythema at Week 24 [Time frame: Baseline and at Week 24]
  • Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24 [Time frame: Baseline and at Week 24]
  • Change from Baseline in CLASI-A Alopecia at Week 24 [Time frame: Baseline and at Week 24]
  • Percentage of Participants With a Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R OMC) Score of 0 or 1 and at Least a 1-Point Reduction at Week 24 [Time frame: At Week 24]
  • Percentage of Participants with BILAG Moderate to Severe Flares [Time frame: up to Week 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Inland Rheumatology Clinical Trials, Inc. — Upland
  • Omega Research Debary, LLC — DeBary
  • South Florida Rheumatology — Hollywood
  • GTL Medical And Research Group — Miami
  • Bolanos Clinical Research — Pembroke Pines
  • Vantage Clinical Trials — Tampa
  • Dawes Fretzin Clinical Research Group, LLC — Indianapolis
  • Accurate Clinical Research Inc. - Lake Charles — Lake Charles
  • … and 4 more centers
Canada · 1 center
  • The Medical Arts Health Research Group - 300128547 — Kelowna

Identifiers

NCT: NCT07355218 · MS504908_0008 · 2025-524855-30-00 · 169831

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗