A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)

Part of paid clinical trials in Upland, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT07355218
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cutaneous Lupus Erythematosus
  • Systematic Lupus Erythematosus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Enpatoran — DRUG
    Participants will receive a dose of Enpatoran orally twice daily from Day 1 to Day 168.
  • Placebo — 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) — DRUG
    Participants will receive Investigator-recommended SoC.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
May 2026
Primary completion
May 25, 2029
Completion
May 25, 2029

Study Design

Enrollment
202 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enpatoran
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 [ Time Frame: At Week 24 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Inland Rheumatology Clinical Trials, Inc.UplandCalifornia91786-
Omega Research Debary, LLCDeBaryFlorida32713-
Bolanos Clinical ResearchPembroke PinesFlorida33026-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-

Find similar trials in Upland, CA

By research site
Inland Rheumatology Clinical Trials, Inc.· Upland, CAOmega Research Debary, LLC· DeBary, FLBolanos Clinical Research· Pembroke Pines, FLDawes Fretzin Clinical Research Group, LLC· Indianapolis, IN

Related Studies