Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Open-Label Envudeucitinib, Blinded 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 oral small molecule developed by Alumis Inc. (ticker ALMS). It is being studied in hepatic impairment, plaque psoriasis, and systemic lupus erythematosus (SLE). It is a kinase inhibitor that has not been approved by the FDA and remains in clinical development.
Envudeucitinib targets TYK2, a kinase involved in inflammatory signaling. It belongs to the -tinib kinase inhibitor class. By targeting TYK2, the drug is designed to modulate immune pathways relevant to inflammatory conditions such as plaque psoriasis and SLE.
Envudeucitinib is developed by Alumis Inc., which trades under the ticker ALMS. Alumis is running the clinical program, including Phase 1 and Phase 3 studies of the drug across hepatic impairment and plaque psoriasis.
Envudeucitinib is in clinical development, with Phase 1 and Phase 3 trials conducted. It is investigational and has not been approved by the FDA. The program includes four trials in total, of which two are active and two are completed, with 3,619 participants enrolled overall.
Envudeucitinib trials include NCT06952634, a completed Phase 1 study in hepatic impairment with 32 participants, and three Phase 3 plaque psoriasis studies: NCT06846541, which is active and not recruiting with 1,680 participants, plus completed trials NCT06588738 and NCT06586112.
Yes. Envudeucitinib is also known as ESK-001, and trial records use both names. Searches for open-label Envudeucitinib or blinded Envudeucitinib refer to the same Alumis Inc. TYK2 inhibitor program in hepatic impairment, plaque psoriasis, and SLE.