ESK-001 for Uveitis (OPTYK-1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Alumis Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects for ESK-001 aren't listed here, common side effects for treatments targeting inflammation may include increased risk of infection, potential liver issues, possible impact on blood pressure and vision changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the efficacy between 2 ESK-001 treatment groups for the treatment of active NIU as measured by the proportion of patients failing treatment by Week 24

Secondary study objectives

To assess the safety and tolerability of ESK-001 in patients with active NIU by comparing the incidence and proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

To characterize the pharmacokinetics (PK) of ESK-001 (Cmax)

To characterize the pharmacokinetics (PK) of ESK-001 (Ctrough)

+1 more