ESK-001 for Uveitis

(OPTYK-1 Trial)

Recruiting at 17 trial locations

Overseen By Alumis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alumis Inc

Must not be taking: Live vaccines

Disqualifiers: Infectious uveitis, Glaucoma, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ESK-001, a medication for treating specific non-infectious eye inflammations. It aims to help patients whose conditions are not caused by infections by reducing immune response and inflammation.

Do I need to stop my current medications to join the trial?

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.

What data supports the effectiveness of the drug ESK-001 for treating uveitis?

The research mentions certolizumab pegol, a drug similar to ESK-001, which has been studied for its effectiveness in treating active uveitis. This suggests that drugs targeting inflammation, like ESK-001, may also be effective in managing uveitis. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults aged 18-70 with active noninfectious uveitis, which is an eye inflammation affecting the middle or back parts of the eye. Participants must not have severe glaucoma, recent cancer, substance abuse history, planned surgeries during the study, or certain infections like HIV or tuberculosis.

Inclusion Criteria

Able and willing to provide consent

I have been diagnosed with a type of eye inflammation that is not caused by an infection.

I will use effective birth control during the study.

Exclusion Criteria

History of chronic drug or alcohol abuse

I have been diagnosed with an eye infection called uveitis.

I do not have active HIV, Hepatitis B or C, or tuberculosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Treatment

Participants receive one of two doses of ESK-001 daily for 24 weeks

24 weeks

Extension

Participants who do not meet treatment failure criteria continue treatment

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ESK-001

Trial Overview The trial tests ESK-001's effectiveness and safety in treating different types of noninfectious uveitis. It's a multi-center study where patients are randomly assigned to receive ESK-001 while researchers and participants don't know who gets the actual drug versus a placebo (double-masked).

Participant Groups

Group I: ESK-001 Dose Level 2 Experimental Treatment 1 Intervention

ESK-001 administered as an oral tablet

Group II: ESK-001 Dose Level 1 Experimental Treatment 1 Intervention

ESK-001 administered as an oral tablet

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

Findings from Research

In a study of 7 patients with chronic-relapsing uveitis who had previously failed other treatments, 71.4% achieved quiescence after 10.4 months of treatment with certolizumab pegol (CZP).

Visual acuity improved significantly after 1 and 6 months of treatment, and no adverse events were reported, indicating that CZP is a safe and effective option for refractory uveitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol, a New Anti-TNF-α in the Armamentarium against Ocular Inflammation. Llorenç, V., Mesquida, M., Sainz de la Maza, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Certolizumab Pegol, a New Anti-TNF-α in the Armamentarium against Ocular Inflammation. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Uveitis. A status assessment]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Understanding uveitis: the impact of research on visual outcomes. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Structural Endpoints and Outcome Measures in Uveitis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Review of Ocular Drug Delivery Platforms and Drugs for Infectious and Noninfectious Uveitis: The Past, Present, and Future. [2021]