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Monoclonal Antibodies

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

OPTYK-1 Trial Summary

This trial tests a new treatment for eye inflammation in patients with a specific type of eye disease.

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.Check my eligibility

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).See study design

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.

OPTYK-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

OPTYK-1 Trial Design

2Treatment groups

Experimental Treatment

Group I: ESK-001 Dose Level 2Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Group II: ESK-001 Dose Level 1Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ESK-001

2022

Completed Phase 2

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alumis IncLead Sponsor

5 Previous Clinical Trials

889 Total Patients Enrolled

Media Library

ESK-001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05953688 — Phase 2

Noninfectious Panuveitis Research Study Groups: ESK-001 Dose Level 1, ESK-001 Dose Level 2

Noninfectious Panuveitis Clinical Trial 2023: ESK-001 Highlights & Side Effects. Trial Name: NCT05953688 — Phase 2

ESK-001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05953688 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment criteria for this experiment limited to those under 70 years old?

"This medical trial is open to individuals who have surpassed 18 years of age and are yet to reach 70."

Answered by AI

Are there vacancies for volunteers to participate in this experiment?

"Affirmative, the information posted on clinicaltrials.gov affirms that this medical experiment is actively searching for patients. This was first published on June 14th 2023 and recently updated July 18th 2023. The team leading this study are hoping to find 30 people between two sites."

Answered by AI

What risks are associated with the administration of ESK-001 Dose Level 1?

"Our team has rated the safety of ESK-001 Dose Level 1 a 2, as it is currently undergoing testing in Phase 2 clinical trials. This implies that there exists some preliminary evidence for its safety but none regarding its efficacy yet."

Answered by AI

Does my profile meet the requirements to take part in this research trial?

"To partake in this clinical trial, prospective patients must have intermediate uveitis and be between 18-70 years of age. A maximum of 30 people can join the study."

Answered by AI

What is the total participant count for this medical experiment?

"Yes, the clinicaltrials.gov database indicates that this medical experiment has been actively seeking participants since June 14th 2023 and was last updated on July 18th 2023. 30 individuals need to be recruited from two different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU

2023. "POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05953688.

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