Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
envudeucitinib · 6 trials · 7 indications
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 |
| ESK-001 Dose Level 1 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 2 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 3 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| envudeucitinib Dose Level 1 | EXPERIMENTAL | envudeucitinib administered as an oral tablet |
| envudeucitinib Dose Level 2 | EXPERIMENTAL | envudeucitinib administered as an oral tablet |
| Healthy Volunteer | EXPERIMENTAL | Up to 24 healthy volunteer participants will receive a single dose of ESK-001 |
| Mild Hepatic Impairment | EXPERIMENTAL | 8 participants with mild hepatic impairment will receive a single dose of ESK-001 |
| Moderate Hepatic Impairment | EXPERIMENTAL | 8 participants with moderate hepatic impairment will receive a single dose of ESK-001 |
| Severe Hepatic Impairment | EXPERIMENTAL | 8 participants with severe hepatic impairment will receive a single dose of ESK-001 |
| 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...