Izokibep for Uveitis

No longer recruiting at 61 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called izokibep for individuals with uveitis, a type of eye inflammation. The goal is to determine if izokibep can reduce inflammation in cases requiring high doses of steroids. Participants will receive either izokibep or a placebo (a substance with no active medication) once a week for about a year. This trial targets those diagnosed with active non-infectious intermediate-, posterior-, or pan-uveitis who are on stable doses of oral corticosteroids. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that izokibep is likely to be safe for humans?

Research has shown that izokibep is generally safe for use. In a study on non-infectious uveitis, an eye inflammation, izokibep's safety profile matched that of other drugs targeting IL-17A, a protein associated with inflammation. Another study involving individuals with psoriatic arthritis, a type of joint inflammation, found no deaths, new cases of eye inflammation, or suicidal thoughts linked to izokibep. While izokibep remains under investigation, it has demonstrated a consistent safety record in past trials for various conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for uveitis?

Unlike the standard treatments for uveitis, which often include corticosteroids and immunosuppressive drugs, Izokibep is unique because it specifically targets the interleukin-17A (IL-17A) protein. This protein plays a significant role in inflammatory responses, and by inhibiting it, Izokibep aims to reduce inflammation more effectively. Additionally, Izokibep is administered subcutaneously once a week, which could offer a more convenient and potentially more consistent treatment regimen compared to some existing therapies. Researchers are excited about Izokibep because it represents a targeted approach that might offer better control of inflammation with fewer side effects.

What evidence suggests that izokibep might be an effective treatment for uveitis?

In this trial, participants will receive either izokibep or a placebo. Research shows that izokibep, a small protein, blocks interleukin-17A, a protein believed to cause inflammation. In a previous study on non-infectious uveitis, 45% of patients using izokibep experienced treatment failure after 24 weeks, compared to 50.7% of those given a placebo. Although this difference wasn't statistically significant, it suggests some effectiveness. Other studies have shown promising results for izokibep; for instance, in a trial for hidradenitis suppurativa (a skin condition), 40% of patients experienced significant improvement, twice the rate of those on a placebo. These findings suggest that izokibep might help reduce inflammation in uveitis patients as well. ^{2 3 5 6 7}

Who Is on the Research Team?

Donald Betah

Principal Investigator

ACELYRIN Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05384249

NCT05384249 | Phase 2b Pivotal Study of Izokibep in Non- ...

This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

2.

ard.bmj.com

ard.bmj.com/content/83/suppl_1/235

LBA0005 EFFICACY AND SAFETY OF IZOKIBEP, A ...

Serious AEs were reported at low rates (2%, 3%, and 1%). Rates of ulcerative colitis (1%, 1%, and 0%) and candidiasis (0%, 1%, and 1%) were also low. No deaths, ...

3.

modernretina.com

modernretina.com/view/phase-2b-3-trial-of-izokibep-in-non-infectious-non-anterior-uveitis-does-not-meet-primary-endpoint

Phase 2b/3 trial of izokibep in non-infectious, non-anterior ...

In the trial, the treatment failure rate at 24 weeks was 45.0% (p-value: 0.4914) for izokibep and 50.7% for placebo. Statistical significance ...

4.

dermatologytimes.com

dermatologytimes.com/view/izokibep-reaches-key-efficacy-endpoints-in-phase-3-hs-trial

Izokibep Reaches Key Efficacy Endpoints in Phase 3 HS ...

The trial revealed that 40% of patients on izokibep achieved HiSCR75 by week 16, a notable improvement over the 20% on placebo.

5.

druganddeviceworld.com

druganddeviceworld.com/2025/09/12/affibodys-izokibep-shows-phase-iii-success-after-past-setbacks/

Affibody's izokibep shows Phase III success after past ...

Affibody reports strong hidradenitis suppurativa (HS) trial data for izokibep, following Acelyrin's failed efforts in uveitis.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04706741

Study Details | NCT04706741 | A Trial of the Efficacy and ...

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0003496725008155

Psoriatic arthritis Efficacy and safety of izokibep in patients ...

This randomised, double-blind, phase 2 study is the first evaluation of izokibep, a small protein therapeutic designed to inhibit IL-17A, in patients with PsA.