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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-25

Study Completion Date

2029-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Enpatoran

Group Type EXPERIMENTAL

Enpatoran

Intervention Type DRUG

Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.

Standard of care (SoC)

Intervention Type DRUG

Participants will receive Investigator-recommended SoC.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.

Standard of care (SoC)

Intervention Type DRUG

Participants will receive Investigator-recommended SoC.

Interventions

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Enpatoran

Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.

Intervention Type DRUG

Placebo

Participants will receive a single oral dose of a placebo matching Enpatoran tablet twice daily from Day 1 to Day 168.

Intervention Type DRUG

Standard of care (SoC)

Participants will receive Investigator-recommended SoC.

Intervention Type DRUG

Other Intervention Names

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M5049

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No