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NotableLead sponsor: EMD Serono Research & Development Institute, Inc. to EMD Serono Research & Development Institute, Inc.Primary endpoints: details revised at 1 of 1 entry · Trial sites expanded: 45 → 60 locations · Eligibility criteria expanded, about 15 words · 1 moreShow 4 more changesShow less
Primary endpoints: details revised at 1 of 1 entry
Trial sites expanded: 45 → 60 locations
Eligibility criteria expanded, about 15 words
Secondary endpoints: details revised at 12 of 14 entries
MinorTrial sites expanded: 18 → 45 locationsv11
MinorTrial sites expanded: 13 → 18 locationsv10
MinorStudy sites: 11 to 13v9
MinorTrial sites expanded: 5 → 11 locationsv8
Show 2 earlier versionsHide 2 earlier versions
MinorStudy sites: 3 to 5v7
MinorStudy sites: 2 to 3v6
NotableRecruitment openedStudy sites: 1 to 2 · Start date changed from estimate of Mar 27, 2026 to Mar 10, 2026 · Collaborator revisedv5Show 3 more changesShow less
Study sites: 1 to 2
Start date changed from estimate of Mar 27, 2026 to Mar 10, 2026
NotableLead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany to EMD Serono Research & Development Institute, Inc.Collaborator revisedv4Show 1 more changeShow less
NotableStart date: Feb 25, 2026 to Mar 27, 2026Primary and study completion dates: Mar 19, 2029 to May 24, 2029v3Show 1 more changeShow less
Primary and study completion dates: Mar 19, 2029 to May 24, 2029
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.