ESK-001 for Uveitis
(OPTYK-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral medication, ESK-001, which might help treat uveitis, a type of eye inflammation. It will assess the medication's effectiveness and safety by comparing two different dose levels. Individuals with active, noninfectious uveitis in at least one eye and symptoms like inflammation in the back part of the eye may qualify. Participants must agree to use effective birth control during the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in uveitis treatment.
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.
Is there any evidence suggesting that ESK-001 is likely to be safe for humans?
Research shows that ESK-001 has been tested for safety in other conditions. In studies on plaque psoriasis, ESK-001 proved to be safe, prompting further trials. This indicates that participants generally tolerated the treatment well in those studies. Additionally, ongoing long-term studies are examining the safety of ESK-001 over extended periods.
While specific safety data from studies on uveitis is not yet available, positive results in other conditions offer some reassurance about its safety. However, since this trial is in an early stage, researchers are still carefully monitoring the treatment's safety in humans. Participants should consult their healthcare providers if they have any concerns.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ESK-001 for uveitis because it offers a new approach compared to current treatments, which typically include corticosteroids and immunosuppressive drugs. Unlike these options, ESK-001 is taken as an oral tablet, which could improve patient convenience and adherence. Most importantly, ESK-001 may have a novel mechanism of action that targets specific pathways involved in inflammation, potentially offering more effective and targeted relief for those suffering from uveitis. This could mean fewer side effects and better outcomes for patients.
What evidence suggests that ESK-001 might be an effective treatment for uveitis?
Research has shown that ESK-001 could be a promising treatment for uveitis, an eye condition. In this trial, participants will receive either ESK-001 Dose Level 1 or Dose Level 2. Earlier studies revealed that patients who received the highest dose of ESK-001 experienced noticeable improvement in vision clarity after one and six months of treatment. This suggests the treatment might help people with uveitis see better. Additionally, ESK-001 was well-tolerated in other studies, with most patients showing significant skin improvement when tested for other conditions. These findings support its potential effectiveness in treating uveitis.14678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one of two doses of ESK-001 daily for 24 weeks
Extension
Participants who do not meet treatment failure criteria continue treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ESK-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alumis Inc
Lead Sponsor