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

Официальное название

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)

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: At Week 24]

Вторичные конечные точки (12)

• Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response [Срок оценки: At Week 24]
• Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [Срок оценки: From Day 1 to Week 24]
• Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [Срок оценки: From Day 1 to Week 24]
• Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24 [Срок оценки: At Week 24]
• Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline [Срок оценки: At Weeks 4 and 24]
• Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [Срок оценки: 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 [Срок оценки: Baseline and at Week 24]
• Change from Baseline in CLASI-A Erythema at Week 24 [Срок оценки: Baseline and at Week 24]
• Change from Baseline in CLASI-A Scale/Hypertrophy at Week 24 [Срок оценки: Baseline and at Week 24]
• Change from Baseline in CLASI-A Alopecia at Week 24 [Срок оценки: 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 [Срок оценки: At Week 24]
• Percentage of Participants with BILAG Moderate to Severe Flares [Срок оценки: up to Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 12 центров

• 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
• … и ещё 4 центра

Канада · 1 центр

• The Medical Arts Health Research Group - 300128547 — Kelowna

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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