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 kinase inhibitor being developed for plaque psoriasis, systemic lupus erythematosus (SLE), and hepatic impairment. It is currently in Phase 2 clinical development for these indications.
Envudeucitinib is a small molecule that belongs to the -tinib class of kinase inhibitors. It is being studied for its effects in immunology-related conditions, specifically plaque psoriasis and SLE.
Envudeucitinib is being developed by Alumis Inc., a biopharmaceutical company. Alumis Inc. is publicly traded under the ticker symbol ALMS.
Envudeucitinib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy.
Envudeucitinib is being studied in four clinical trials. Two are active: NCT05739435, an open-label extension in plaque psoriasis, and NCT05966480, a placebo-controlled study in SLE. Two Phase 3 trials, NCT06588738 and NCT06846541, are listed as completed or active, though the drug is still in Phase 2.
Envudeucitinib is also known as ESK-001. Clinical trial records refer to the drug as ESK-001, and it is being evaluated under this name in studies for plaque psoriasis and SLE.