Izokibep for Uveitis

Recruiting at 59 trial locations

Overseen By Donald Betah

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ACELYRIN Inc.

Must be taking: Corticosteroids

Disqualifiers: Anterior uveitis, Serpiginous choroidopathy, Infectious uveitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you continue taking stable doses of oral corticosteroids for at least 2 weeks before starting the study.

What data supports the effectiveness of the drug Izokibep for treating uveitis?

Research on similar treatments, like anti-TNFα drugs and other antibodies, shows they can be effective for uveitis, suggesting that Izokibep might also help. For example, studies on drugs like infliximab and certolizumab pegol have shown positive results in treating uveitis. ^{1 2 3 4 5}

How is the drug Izokibep different from other treatments for uveitis?

Izokibep is unique because it may offer a novel approach to treating uveitis by targeting specific immune pathways, potentially providing an alternative to traditional immunosuppressive drugs like corticosteroids and biological agents such as infliximab and adalimumab, which are commonly used in Japan. ^{3 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Donald Betah

Principal Investigator

ACELYRIN Inc.

Eligibility Criteria

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.

Inclusion Criteria

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

Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

My condition hasn't improved despite taking stable corticosteroid doses for 2 weeks.

Exclusion Criteria

I have wet age-related macular degeneration.

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

I have been diagnosed with serpiginous choroidopathy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either izokibep or placebo subcutaneously once weekly

51 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Izokibep

Trial Overview 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.

Participant Groups

Group I: Group 2: Izokibep subcutaneous once weekly Experimental Treatment 1 Intervention

Participants will receive izokibep every week to week 51.

Group II: Group 1: Placebo subcutaneous once weekly Placebo Group 1 Intervention

Participants will receive placebo every week to week 51.

Who Is Running the Clinical Trial?

ACELYRIN Inc.

Lead Sponsor

Trials

9

Recruited

1,100+

Findings from Research

In a study of 1702 patients with multiple sclerosis (MS), only 0.52% were found to have uveitis, with the most common types being panuveitis and intermediate uveitis, primarily affecting women.

Despite the low frequency, uveitis can lead to significant complications like cataracts and glaucoma, and after treatment, visual acuity improved in 11 out of 16 affected eyes, highlighting the need for careful assessment and potential surgical intervention in MS patients experiencing visual loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uveitis associated with multiple sclerosis: complications and visual prognosis. Kaya, D., Kaya, M., Özakbaş, S., et al.[2020]

In a study of 21 patients with longstanding uveitis, treatment with golimumab (GOL) or certolizumab pegol (CZP) significantly reduced the frequency of ocular flares from 128.6 to 42.9 events per 100 patients-year, indicating their efficacy as treatment options.

Both GOL and CZP demonstrated good long-term retention rates (54.5% for CZP and 50.0% for GOL) and had an excellent safety profile, making them viable alternatives for patients who had previously not responded to other TNF-α blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of certolizumab pegol and golimumab in the treatment of non-infectious uveitis. Tosi, GM., Sota, J., Vitale, A., et al.[2019]

References

1. China pubmed.ncbi.nlm.nih.gov

Uveitis associated with multiple sclerosis: complications and visual prognosis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Changing evidence over time: updated meta-analysis regarding anti-TNF efficacy in childhood chronic uveitis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Interleukin-1β-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behcet's disease: an open-label pilot study. [2017]

4. Italy pubmed.ncbi.nlm.nih.gov

Efficacy and safety of certolizumab pegol and golimumab in the treatment of non-infectious uveitis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Ten-year follow-up of infliximab treatment for uveitis in Behçet disease patients: A multicenter retrospective study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Chronic candida endophthalmitis as a cause of intermediate uveitis. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Recent developments in the treatment of posterior uveitis. [2012]

8. England pubmed.ncbi.nlm.nih.gov

Current standardized therapeutic approach for uveitis in Japan. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Changing patterns of intraocular inflammatory disease in Japan. [2022]