What side effects are associated with this type of intervention?

Common treatments for uveitis, particularly those involving interleukin-17A inhibition like Izokibep, include biologics such as secukinumab and ixekizumab. Known side effects of these treatments can include nasopharyngitis, upper respiratory tract infections, and injection site reactions. Broader treatments for uveitis, such as corticosteroids and immunosuppressive agents, may cause side effects like increased intraocular pressure, cataracts, and systemic effects such as hypertension and hyperglycemia.

What prior FDA approvals exist?

Izokibep is being studied for the treatment of non-infectious uveitis by targeting interleukin-17A. While the provided context does not mention specific FDA-approved drugs for uveitis that act on interleukin-17A, it does highlight the use of biologic agents in similar inflammatory conditions. For instance, drugs like secukinumab and ixekizumab, which also inhibit interleukin-17A, have been approved for conditions such as plaque psoriasis and psoriatic arthritis. These approvals suggest a potential therapeutic role for interleukin-17A inhibitors in treating uveitis.

What other types of research exist?

Promising alternatives to Izokibep for Uveitis patients include: 1) Ustekinumab, an IL-12/23 inhibitor, which has shown efficacy in various inflammatory conditions. 2) Risankizumab, an IL-23 inhibitor, which has demonstrated positive results in inflammatory diseases. 3) Secukinumab, another IL-17A inhibitor, which could be considered if not previously tried. These alternatives target similar inflammatory pathways and have shown efficacy in related conditions.

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Interleukin-17A Inhibitor

Izokibep for Uveitis

Phase 2

Recruiting

Research Sponsored by ACELYRIN Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosed with non-infectious intermediate-, posterior- or pan-uveitis

Aged between 18 to 75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10 up to week 52

Awards & highlights

Study Summary

This trial is testing izokibep, a small protein molecule, as a possible treatment for active non-infectious uveitis, a condition which causes inflammation in the eye.

Who is the study for?

Adults aged 18-75 with non-infectious intermediate, posterior, or pan-uveitis needing high-dose steroids can join. They must have active disease despite current steroid treatment and give informed consent. Excluded are those with certain eye conditions like serpiginous choroidopathy, high intraocular pressure, very poor vision in one eye, wet macular degeneration, isolated anterior uveitis, suspected infectious uveitis or other specific eye issues.Check my eligibility

What is being tested?

The trial is testing Izokibep—a molecule that targets interleukin-17A to reduce inflammation—against a placebo in patients with active non-infectious uveitis who require steroids. The goal is to see if Izokibep can control the inflammation better than a placebo.See study design

What are the potential side effects?

Potential side effects of Izokibep may include reactions at the injection site, increased risk of infections due to immune system suppression and possibly other inflammatory responses since it affects the immune system's activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10 up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10 up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10 up to week 52 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to treatment failure defined as reaching treatment failure by meeting ≥ 1 of the 4 criteria specified in the protocol in at least 1 eye.

Secondary outcome measures

Change in best corrected visual acuity (BCVA) from best state achieved

Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)

Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 2: Izokibep subcutaneous once weeklyExperimental Treatment1 Intervention

Participants will receive izokibep every week to week 51.

Group II: Group 1: Placebo subcutaneous once weeklyPlacebo Group1 Intervention

Participants will receive placebo every week to week 51.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Izokibep

2022

Completed Phase 2

~190

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Izokibep, a selective inhibitor of interleukin-17A (IL-17A), targets a key cytokine involved in the inflammatory response associated with uveitis. IL-17A promotes the recruitment and activation of immune cells, leading to inflammation and tissue damage in the eye. By inhibiting IL-17A, Izokibep reduces this inflammatory cascade, potentially decreasing the severity and frequency of uveitis flares. This is particularly important for uveitis patients as it can help preserve vision and reduce the need for high-dose steroids, which have significant side effects. Other common treatments for uveitis include corticosteroids, which broadly suppress inflammation, and immunosuppressive agents like methotrexate and cyclosporine, which inhibit various aspects of the immune response to control inflammation.