Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ESK-001 · 4 trials · 4 indications
Proportion of patients with moderate to severe psoriasis achieving ≥75% reduction in PASI score
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms
| Arm | Type | Description |
|---|---|---|
| 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 |
| ESK-001 Dose Level 4 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| ESK-001 Dose Level 5 | EXPERIMENTAL | ESK-001 administered as an oral tablet |
| Placebo | PLACEBO_COMPARATOR | Placebo administered as an oral tablet |
| Healthy Volunteer | EXPERIMENTAL | Up to 24 healthy volunteer participants will receive a single dose of ESK-001 |
| Mild Renal Impairment | EXPERIMENTAL | 8 participants with mild renal impairment will receive a single dose of ESK-001 |
| Moderate Renal Impairment | EXPERIMENTAL | 8 participants with moderate renal impairment will receive a single dose of ESK-001 |
| Severe Renal Impairment | EXPERIMENTAL | 8 participants with severe Renal impairment will receive a single dose of ESK-001 |
| Treatment 1: (Therapeutic dose) | EXPERIMENTAL | 1 oral dose of ESK-001 |
| Treatment 2: (Supratherapeutic dose) | EXPERIMENTAL | 1 oral dose of ESK-001 |
| Treatment 3: ESK-001-matched placebo | PLACEBO_COMPARATOR | - |
| Treatment 4: (positive control) | ACTIVE_COMPARATOR | Moxifloxacin 400 mg tablet |
| ESK-001 Liquid | EXPERIMENTAL | ESK-001 administered as an oral liquid |
| ESK-001 Tablet Fasted | EXPERIMENTAL | ESK-001 administered as an oral tablet in the fasted state |
| ESK-001 Tablet Fed | EXPERIMENTAL | ESK-001 administered as an oral tablet in the fed state |
| ESK-001 and Rabeprazole | EXPERIMENTAL | ESK-001 administered as an oral tablet with rabeprazole |
| Name | Type | Description |
|---|---|---|
| ESK-001 | DRUG | Oral tablet |
| Placebo | DRUG | Oral tablet |
| Moxifloxacin (400 mg) | DRUG | positive control |
| Rabeprazole | DRUG | Oral Tablet |
Inclusion Criteria: * Total body weight \>40 kg (88 lb) * Men and woman age 18-75 * Men and Women must use highly effective methods of contraception for the entirety of the study Exclusion Criteria: * History of malignancy within the last 5 years * Positive for HIV, Hepatitis B or C * History of ...
ESK-001 is an investigational small molecule being studied for plaque psoriasis. It has also been evaluated in healthy volunteers for pharmacokinetics, renal impairment, and cardiac safety. Clinical trials have assessed its efficacy and safety in patients with plaque psoriasis.
ESK-001 is being developed by Alumis Inc., a biopharmaceutical company. Alumis is publicly traded under the ticker symbol ALMS.
ESK-001 is in clinical development. It has completed Phase 1 trials in healthy volunteers and a Phase 2 trial in patients with plaque psoriasis. It is not yet FDA approved and remains investigational.
ESK-001 has been studied in several completed trials. NCT05330858 evaluated tablet versus liquid bioavailability in healthy participants. NCT05600036 assessed efficacy and safety in plaque psoriasis. NCT06962774 studied renal impairment, and NCT07378579 evaluated cardiac safety.
ESK-001 is the primary name for this investigational drug. No alternative names have been reported in clinical trial records.