A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease

Purpose

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.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Cutaneous Lupus Erythematosus (CLE)

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Enpatoran
  • Drug: Enpatoran
    Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
    Other names:
    • M5049
  • Drug: Standard of care (SoC)
    Participants will receive Investigator-recommended SoC.
Placebo Comparator
Placebo
  • 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.

Recruiting Locations

Dermatology Research Associates - 300204025
Los Angeles, California 90045

Revival Research Institute, LLC
Troy, Michigan 48084

Arthritis and Rheumatology Research Institute PLLC
Allen, Texas 75013

More Details

Status
Recruiting
Sponsor
EMD Serono Research & Development Institute, Inc.

Study Contact

Communication Center
+49 6151 72 5200
service@emdgroup.com