A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]

Part of paid clinical trials in Billerica, Massachusetts.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT07840287
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Sep 1, 2031
Completion
Sep 1, 2031

Study Design

Enrollment
404 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Enpatoran

Primary Outcome Measure

Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI) [ Time Frame: From current LTE study Day 1 to Week 120 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBillericaMassachusetts01821-

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