Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06846541 | Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis | PHASE3 | ACTIVE NOT_RECRUITING | 1,680 | — | — | Jan 8, 2025 | Nov 1, 2028 | Apr 13, 2026 | 268 | United States, Australia +14 |
| NCT06588738 | A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 | PHASE3 | COMPLETED | 862 | — | — | Aug 20, 2024 | Dec 18, 2025 | Apr 13, 2026 | 124 | United States, Austria +10 |
| NCT06586112 | A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis | PHASE3 | COMPLETED | 912 | — | — | Jul 25, 2024 | Nov 20, 2025 | Apr 13, 2026 | 156 | United States, Australia +8 |
| NCT05739435 | Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis | PHASE2 | ACTIVE NOT_RECRUITING | 165 | — | — | Jan 17, 2023 | Dec 30, 2026 | Apr 1, 2026 | 38 | United States, Canada |
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Proportion of patients achieving ≥75% reduction in PASI score. Proportion of patients achieving a score of 0 or 1 on sPGA.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Open-Label ESK-001 | EXPERIMENTAL | Open-Label ESK-001 administered as an oral tablet |
| Blinded ESK-001 | EXPERIMENTAL | Blinded ESK-001 administered as an oral tablet |
| Placebo | PLACEBO_COMPARATOR | Matching placebo administered as an oral tablet |
| ESK-001 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| Apremilast | ACTIVE_COMPARATOR | Apremilast administered as an oral capsule |
| envudeucitinib Dose Level 1 | EXPERIMENTAL | envudeucitinib administered as an oral tablet |
| envudeucitinib Dose Level 2 | EXPERIMENTAL | envudeucitinib administered as an oral tablet |
| Name | Type | Description |
|---|---|---|
| Open-Label Envudeucitinib | DRUG | Open-Label ESK-001 |
| Blinded Envudeucitinib | DRUG | Blinded ESK-001 during Randomized Treatment Withdrawal Period |
| Placebo | DRUG | Placebo during Randomized Treatment Withdrawal Period |
| Envudeucitinib | DRUG | ESK-001 |
| Apremilast | DRUG | Apremilast |
Inclusion Criteria: 1. Males or females, age ≥18 years 2. Completed either of the two previous (parent) studies of ESK-001 (ESK-001-016 or ESK-001-017) 3. ESK-001 safety and tolerability were acceptable in the parent study 4. Women of childbearing potential (WOCBP) and males who are sexually active...