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Clinical trials
catalyst calendar across sponsors →Studies where ALMS is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
13 interventional · 1 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque PsoriasisNCT06846541To assess the long-term safety and tolerability of ESK-001 throughout the duration of the studyRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Open-Label Envudeucitinib, Blinded Envudeucitinib, Placebo | Plaque Psoriasis, Psoriasis (PsO), Psoriasis, Moderate Psoriasis, Severe Psoriasis | 1,680 | Nov 2028 | ≤ 834 d | 2026-04-13 |
| Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque PsoriasisNCT05739435To assess the safety and tolerability of long-term ESK-001 treatmentRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: envudeucitinib | Plaque Psoriasis | 165 | 2027-12-01 | in 469 d | 2026-07-28 |
| Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus ErythematosusNCT05966480To 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 placeboRandomized · Triple-masked · Treatment | Phase 2 | Active, not recruiting | Drug: Envudeucitinib, Placebo | SLE | 408 | 2026-06-23actual | — | 2026-07-21 |
| An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver DamageNCT06952634Maximum observed plasma concentration (Cmax)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: envudeucitinib | Hepatic Impairment | 32 | 2026-03-24actual | — | 2026-05-12 |
| A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001NCT06588738To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placeboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Envudeucitinib, Placebo, Apremilast | Plaque Psoriasis | 862 | 2025-09-23actual | — | 2026-08-10 |
| A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque PsoriasisNCT06586112To determine whether ESK-001 reduces the severity of psoriasis by 75% (using the PASI) or by at least 2 points (using sPGA score) compared to placeboRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Envudeucitinib, Apremilast, Placebo | Plaque Psoriasis | 912 | 2025-09-19actual | — | 2026-08-10 |
| An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal FunctionNCT06962774Maximum observed plasma concentration (Cmax)Non-randomized · Single-masked · Treatment | Phase 1 | Completed | Drug: ESK-001 | Renal Impairment | 16 | 2025-08-01actual | — | 2025-12-10 |
| An Investigational Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of A-005NCT07442149Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE in single oral dose administration of A-005 in healthy adult subjects.Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: A-005, A-005, Placebo | Healthy Volunteer | 135 | 2024-12-18actual | — | 2026-03-02 |
| An Investigational Study to Evaluate the Cardiac Safety Assessment (TQTc Study) of ESK-001NCT07378579Change from baseline in placebo-adjusted QTcF (∆∆QTcF)Randomized · Triple-masked · Treatment | Phase 1 | Completed | Drug: ESK-001, Moxifloxacin (400 mg), Placebo | Healthy Volunteer | 52 | 2024-08-31actual | — | 2026-01-30 |
| POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIUNCT05953688To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24Randomized · Quadruple-masked · Treatment | Phase 2 | Terminatedsponsor's stated reason: Terminated based on interim efficacy data that did not meet the Sponsor's criteria. | Drug: ESK-001 | Uveitis Posterior Non-Infectious, Uveitis, Intermediate, Noninfectious Panuveitis | 36 | 2024-08-13actual | — | 2024-08-28 |
| A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque PsoriasisNCT05600036results2024-07-23To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and PlaceboRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ESK-001, Placebo | Plaque Psoriasis | 228 | 2023-06-29actual | — | 2025-06-18 |
| Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy ParticipantsNCT05431634Incidence of Adverse Events (AEs)Randomized · Double-masked · Treatment | Phase 1 | Completed | Drug: Experimental drug: ESK-001 · Other: Placebo | Safety and Tolerability | 49 | 2022-12-01actual | — | 2023-05-09 |
| Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy ParticipantsNCT05330858Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: ESK-001, Rabeprazole | Pharmacokinetics | 14 | 2022-06-30actual | — | 2023-05-09 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19