Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
408actual
Sites
169
Countries
Argentina, Bulgaria, Chile +18
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-26 | actual | When the study began enrolling |
| Primary completion | 2026-06-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-01 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- SLE
Interventions
- Drug: Envudeucitinib
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTo compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo
measured Week 48
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