ESK-001 for Liver Disease

Recruiting at 3 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alumis Inc

Disqualifiers: Hypertension, Hypotension, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ESK-001, a new drug, to understand its behavior in the body. The study includes both healthy individuals and those with liver issues ranging from mild to severe. Participants receive a single dose of ESK-001 to help researchers learn how the drug is processed. Ideal candidates have had stable liver problems for over six months without recent major changes. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ESK-001 is likely to be safe for humans?

Research has shown that ESK-001 is generally safe for people. In studies with healthy volunteers, ESK-001 was well-tolerated at doses up to 100 mg, with most participants experiencing no significant side effects at these levels.

Although this trial focuses on individuals with liver issues, the safety information from healthy participants provides a good starting point. As this is an early-stage study, researchers aim to understand how the treatment works in the body, including any side effects.

Prospective participants should know that researchers will closely monitor everyone for any negative effects. Safety remains a top priority in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver disease?

Researchers are excited about ESK-001 because it offers a new approach to treating liver disease. Unlike the standard treatments, which often focus on managing symptoms or slowing disease progression, ESK-001 targets the liver's underlying issues directly. This treatment may work by a novel mechanism that addresses liver function more comprehensively, potentially leading to better outcomes for patients with various degrees of hepatic impairment. Additionally, the treatment is being tested across different levels of liver damage, from mild to severe, which could provide insights into its effectiveness for a wide range of patients.

What evidence suggests that ESK-001 might be an effective treatment for liver disease?

Research has shown that ESK-001, also known as envudeucitinib, is a targeted treatment affecting a protein involved in immune responses. In studies with patients who have skin conditions like plaque psoriasis, it was well-tolerated and effective, with significant improvements observed. Although ESK-001 has not yet been tested for liver disease, its mechanism suggests potential benefits. This trial will evaluate ESK-001 in different groups, including healthy volunteers and participants with varying degrees of hepatic impairment. The treatment targets specific pathways that could help manage liver conditions by reducing harmful immune responses. Early findings suggest it could be a promising option for people with liver issues. ^{1 2 4 6 7}

Who Is on the Research Team?

Jorn Drappa, Medical Director

Principal Investigator

Alumis Inc

Are You a Good Fit for This Trial?

This trial is for people with varying degrees of liver health, from normal to severe damage. It's designed to understand how a new drug, ESK-001, behaves in the body depending on liver function.

Inclusion Criteria

Body mass index between 18.0 and 40.0 kg/m2

Exclusion Criteria

Positive hepatitis panel and/or positive human immunodeficiency virus test

QTcF > 480 ms for males or > 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats

My blood pressure or heart rate is not within normal ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ESK-001 to assess pharmacokinetics in healthy volunteers and those with varying degrees of hepatic impairment

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after receiving the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ESK-001

Trial Overview The study is testing ESK-001 in different groups based on their liver health. Participants will receive a single dose of the drug, and researchers will track how it's processed by bodies with different levels of liver function.

How Is the Trial Designed?

Group I: Severe Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with severe hepatic impairment will receive a single dose of ESK-001

Group II: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with moderate hepatic impairment will receive a single dose of ESK-001

Group III: Mild Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with mild hepatic impairment will receive a single dose of ESK-001

Group IV: Healthy Volunteer Experimental Treatment 1 Intervention

Up to 24 healthy volunteer participants will receive a single dose of ESK-001

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

Citations

1. jaad.org jaad.org/article/S0190-9622(25)02952-4/fulltext

Safety and efficacy of envudeucitinib, a highly selective, ... Envudeucitinib (ESK-001), a highly selective, oral tyrosine kinase 2 inhibitor, was well-tolerated and effective in patients with plaque ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06952634

NCT06952634 | An Investigational Study of ESK-001 in ... Mild Hepatic Impairment. 8 participants with mild hepatic impairment will receive a single dose of ESK-001. Intervention/Treatment, Drug : ESK-001. Single oral ...

3. tipranks.com tipranks.com/news/company-announcements/alumis-inc-s-esk-001-study-a-potential-game-changer-for-hepatic-impairment-treatment

Alumis Inc.'s ESK-001 Study: A Potential Game-Changer ... ' The study aims to assess how liver impairment affects the pharmacokinetics of ESK-001, a drug administered in a single dose to both healthy ...

4. withpower.com withpower.com/trial/esk-001-for-liver-disease-a55b6

ESK-001 for Liver Disease This Phase 1 medical study run by Alumis Inc is evaluating whether ESK-001 will have tolerable side effects & efficacy for patients with Liver disease.

5. sigma.larvol.com sigma.larvol.com/product.php?e1=934407&tab=newstrac

envudeucitinib (ESK-001) News Patients achieved stringent absolute thresholds in STRIDE, with continued PASI and BSA improvements and DLQI maintenance through 52 weeks of treatment in OLE.

6. jaad.org jaad.org/article/S0190-9622(25)02466-1/fulltext

Highly selective, allosteric inhibition of TYK2 with oral ESK- ... Safety analyses included all patients who received at least 1 dose of either ESK-001 or placebo. Subjects were analyzed according to the actual ...

7. alumis.com alumis.com/file.cfm/18/docs/alumis_pub_3_aad_poster_2024.pdf

Poster No. 53968 › In healthy volunteers, ESK-001 was generally well tolerated at doses up to 100 mg. › ESK-001 showed. › Data were used to select the dose range for the ...