NCT07355218

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
34mo left

Started Apr 2026

Typical duration for phase_3

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026May 2029

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2029

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

3.2 years

First QC Date

January 12, 2026

Last Update Submit

July 16, 2026

Conditions

Systematic Lupus ErythematosusCutaneous Lupus Erythematosus

Keywords

Toll-like Receptor 7Toll-like Receptor 8AdultsSLECLELupusDiscoid lupus erythematosusSubacute cutaneous lupus erythematosusM5049EnpatoranCutaneous manifestationsLupus erythematosusAcute cutaneous lupus erythematosusSystemic lupus erythematosusInterferon gene signature

Outcome Measures

Primary Outcomes (1)

  • 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

    At Week 24

Secondary Outcomes (14)

  • Percentage of Participants With British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response

    At Week 24

  • Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)

    From Day 1 to Week 24

  • Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters

    From Day 1 to Week 24

  • Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24

    At Week 24

  • Percentage of Participants With CLASI-50 Response, Defined as >=50% Decrease in CLASI-A Score From Baseline

    At Weeks 4 and 24

  • +9 more secondary outcomes

Study Arms (2)

Enpatoran

EXPERIMENTAL
Drug: EnpatoranDrug: Standard of care (SoC)

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: Standard of care (SoC)

Interventions

EnpatoranDRUG

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

Also known as: M5049
Enpatoran
PlaceboDRUG

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

Placebo
Standard of care (SoC)DRUG

Participants will receive Investigator-recommended SoC.

EnpatoranPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Inland Rheumatology Clinical Trials, Inc.

Upland, California, 91786, United States

RECRUITING

Omega Research Debary, LLC

DeBary, Florida, 32713, United States

RECRUITING

South Florida Rheumatology

Hollywood, Florida, 33026, United States

RECRUITING

GTL Medical And Research Group

Miami, Florida, 33173, United States

RECRUITING

Bolanos Clinical Research

Pembroke Pines, Florida, 33026, United States

RECRUITING

Vantage Clinical Trials

Tampa, Florida, 33603, United States

RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

RECRUITING

Accurate Clinical Research Inc. - Lake Charles

Lake Charles, Louisiana, 70605, United States

RECRUITING

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

RECRUITING

Arthritis and Osteoporosis Consultants of the Carolinas II, LLC

Charlotte, North Carolina, 28207, United States

RECRUITING

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States

RECRUITING

Accurate Clinical Research

Humble, Texas, 77346, United States

RECRUITING

The Medical Arts Health Research Group - 300128547

Kelowna, British Columbia, V1Y 4Z5, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, DiscoidLupus Erythematosus, Systemic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Medical Responsible

    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Central Study Contacts

US Medical Information

CONTACT

888-275-7376eMediUSA@emdserono.com

Communication Center

CONTACT

+49 6151 72 5200service@emdgroup.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 25, 2029

Study Completion (Estimated)

May 25, 2029

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

IPD supporting publicly available results will be evaluated for sharing.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
IPD from completed trials will be publicly available within 6 months after all of the following events: * Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions * Public results via primary manuscript or trial registry disclosure * Legal authority to share data * Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21
Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
More information

Locations

US(12)CA(1)