Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Open-Label Envudeucitinib
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...
Envudeucitinib is an investigational small molecule being studied for hepatic impairment, plaque psoriasis, and systemic lupus erythematosus (SLE). It is being developed by Alumis Inc. (NASDAQ: ALMS) and is currently in Phase 1 clinical development.
Envudeucitinib targets TYK2, a kinase enzyme involved in inflammatory signaling pathways. By inhibiting TYK2, the drug aims to modulate immune responses implicated in conditions like plaque psoriasis and SLE.
Envudeucitinib is being developed by Alumis Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALMS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Envudeucitinib is in Phase 1 clinical development. While some of its trials are in Phase 3, the drug itself is listed as Phase 1, indicating it is still in early-stage investigation and not yet approved by regulatory authorities.
Envudeucitinib has four clinical trials. NCT06952634 is a completed Phase 1 hepatic impairment study. NCT06846541 is an active Phase 3 long-term safety trial in plaque psoriasis. NCT06588738 and NCT06586112 are completed Phase 3 efficacy trials in moderate to severe plaque psoriasis.
Yes, envudeucitinib is also known as ESK-001. Clinical trial records refer to the drug as ESK-001 in study titles, such as the Phase 3 trials for plaque psoriasis and the hepatic impairment study.