NCT07840287

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\_0001) (NCT07332481) and Elowen-2 (MS504908\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include: Study Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120). Study Intervention: Enpatoran. Intervention Form: Film-coated tablet.

Trial Health

67
Monitor

Trial Health Score

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

Enrollment
404

participants targeted

Target at P50-P75 for phase_3

Timeline
59mo left

Started Oct 2026

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

4.9 years

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

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

Keywords

Toll-like receptor 7Toll-like receptor 8WILLOWElowen-1Elowen-2AdultsSystemic lupus erythematosusCutaneous lupus erythematosusDiscoid lupus erythematosusSubacute cutaneous lupus erythematosusAcute cutaneous lupus erythematosusInterferon-gene signature

Outcome Measures

Primary Outcomes (1)

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

    From current LTE study Day 1 to Week 120

Secondary Outcomes (18)

  • Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)

    From current LTE study Day 1 to Week 120

  • Number of Participants With Abnormalities in Vital Signs

    From current LTE study Day 1 to Week 120

  • Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter

    From current LTE study Day 1 to Week 120

  • 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 Elowen-1/Elowen-2 study Baseline

    Elowen-1/Elowen-2 study Baseline, current LTE study Week 108

  • Percentage of Participants With CLASI-50 Response, Defined as >= 50% Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline

    Elowen-1/Elowen-2 study Baseline, current LTE study Week 108

  • +13 more secondary outcomes

Study Arms (1)

Enpatoran

EXPERIMENTAL
Drug: Enpatoran

Interventions

EnpatoranDRUG

Participants will receive a dose of Enpatoran orally for 108 weeks.

Also known as: M5049
Enpatoran

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
  • Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit.

You may not qualify if:

  • Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study.
  • Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study.
  • Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.
  • All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result.
  • Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor).
  • Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
  • Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.
  • Planned major elective medical or surgical procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Billerica, Massachusetts, 01821, United States

Location

Research Site

Darmstadt, Germany

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLupus Erythematosus, CutaneousLupus Erythematosus, Discoid

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSkin Diseases

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

September 25, 2026

Record last verified: 2026-09

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 researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.
More information

Locations

US(1)DE(1)