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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523871-44-00
Enrollment
16
Registered
2026-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Brief summary

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

Detailed description

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) [ Time Frame: From Day 1 to Week 24 ]., Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [ Time Frame: From Day 1 to Week 24 ]., Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24., Percentage of Participants WithCLASI-50 Response, Defined as>=50% Decrease in CLASI-A Score From Baseline at Weeks 4 and 24., Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [ Time Frame: Day 1 up to Week 12 and thereafter upto Week 24 ].

Interventions

Sponsors

Merck Healthcare KGaA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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) [ Time Frame: From Day 1 to Week 24 ]., Number of Participants With Abnormal (greater than and equal to [>=] Grade 3) laboratory parameters [ Time Frame: From Day 1 to Week 24 ]., Percentage of Participants With CLASI-A less than and equal to (<=) 3 at Week 24., Percentage of Participants WithCLASI-50 Response, Defined as>=50% Decrease in CLASI-A Score From Baseline at Weeks 4 and 24., Percentage of Participants With Clinically Meaningful Corticosteroid (CS) Reduction [ Time Frame: Day 1 up to Week 12 and thereafter upto Week 24 ].

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 1, 2026