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

Waitlist Available

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

Must not have

Subject with neovascular/wet age-related macular degeneration

Subject with intraocular pressure of ≥ 25 mmHg while on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests izokibep, a small protein, in patients with severe eye inflammation who need high-dose steroids. By blocking certain molecules, izokibep aims to reduce inflammation and potentially lower the need for steroids.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have wet age-related macular degeneration.

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My eye pressure is high despite taking two or more glaucoma medications, or I have signs of glaucoma damage to my optic nerve.

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I have been diagnosed with serpiginous choroidopathy.

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I have severe vision problems due to diabetes.

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I have inflammation in the front part of my eye.

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I cannot use certain eye drops or have my pupils dilated for an eye exam.

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I can't see clearly due to severe cloudiness in my eye.

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I have had scleritis within the last year.

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I have or might have an eye infection causing inflammation.

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I have a condition in my eye that could damage my vision not related to inflammation.

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I have a clear eye condition that may need surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 2 trial • 205 Patients • NCT05355805

39%

Injection site erythema

12%

Injection site pruritus

10%

Headache

Nasopharyngitis

Injection site swelling

Injection site pain

Anxiety

Fatigue

Tonsillitis

Pyrexia

COVID-19

Abdominal pain

Muscle spasms

Upper respiratory tract infection

Herpes zoster

Nephrolithiasis

Transaminases increased

Gastroenteritis viral

Contusion

Gout

Abscess rupture

Injection site vesicles

Pain

Dysphagia

Candida infection

Chondropathy

Animal scratch

Drug-induced liver injury

Injection site urticaria

Abdominal discomfort

Depression

Blood pressure increased

Injection site reaction

Urinary tract infection bacterial

Dyspepsia

Hypertension

Gastritis

Hyperglycaemia

Toothache

Meniscus injury

Post-acute COVID-19 syndrome

Tooth fracture

Diarrhoea

Streptococcal infection

Injection site bruising

Injection site induration

Vomiting

Foot fracture

Skin candida

Subcutaneous abscess

Arthralgia

Blood cholesterol increased

Dental caries

Dermatitis contact

Obsessive-compulsive personality disorder

Abdominal pain upper

Urticaria

Skin lesion inflammation

100%

80%

60%

40%

20%

Study treatment Arm

Part B Izokibep 160 mg Q2W - Period 1

Part B Placebo QW/Q2W - Period 1

Part B Izokibep 160 mg QW - Period 1

Part A Izokibep 160 mg QW

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

~220

0 / 13Eligibility 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.