Complete Announced during: Premarket · announced Tue 8:30a ET (premarket); before = Mon close; first trade Tue 9:00a ET; time = SEC 8-K acceptance
Alumis (Nasdaq: ALMS) reported topline results from a Phase 2 trial of envudeucitinib in systemic lupus erythematosus (SLE) on September 1, 2026. The company said the trial did not meet its primary endpoint. ClinicalTrials.gov lists 408 enrolled participants (NCT05966480).
Trial details
- Drug
- EnvudeucitinibType Drug Route oral
- Treats
- Studied as a treatment for systemic lupus erythematosus (SLE) (registry condition: SLE).Condition SLE
- Patients
- 408 patients (actual enrollment)4 arms · 169 sites in 21 countries
- Phase
- Phase 2
- Design
- Randomized, triple-blind, placebo-controlled, parallel-group
- Primary endpoint
- To 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 (Week 48)
- Key secondary endpoints
- To assess the safety and tolerability of multiple dose levels of ESK-001
- To compare the effect on disease activity measured by the proportion of patients achieving an SLE Responder Index of ≥4 (SRI[4]) response at Week 48
- To compare corticosteroid use in patients at Week 48
- Result
- Missed endpoint
- Safety
- In LUMUS, envudeucitinib was well tolerated and demonstrated a favorable safety profile with no new safety signals.
- Sponsor
- Alumis Nasdaq: ALMS
- Dates
- Study start Jun 26, 2023Primary completion Jun 23, 2026Announced Sep 1, 2026, 8:30 AM ET (SEC 8-K filing time)
- Trial ID
- NCT05966480 ClinicalTrials.gov
About this trial
This randomized, triple-blind, placebo-controlled, parallel-group Phase 2 trial (NCT05966480) tested Envudeucitinib in SLE. Studied as a treatment for systemic lupus erythematosus (SLE) (registry condition: SLE). It enrolled 408 patients across 4 arms at 169 sites in 21 countries. The primary endpoint was To 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 (Week 48). Alumis reported that the trial did not meet its primary endpoint. The study started on Jun 26, 2023 and reached primary completion on Jun 23, 2026.
Sources
- Source: SEC EDGAR 8-K (EX-99.1)
- ClinicalTrials.gov record: NCT05966480
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