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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
Select...
I have been diagnosed with a type of eye inflammation that is not caused by an infection.
Select...
I am between 18 and 75 years old.

Timeline

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

Find a Location

Who is running the clinical trial?

ACELYRIN Inc.Lead Sponsor
8 Previous Clinical Trials
958 Total Patients Enrolled
1 Trials studying Uveitis
7 Patients Enrolled for Uveitis
Donald BetahStudy DirectorACELYRIN Inc.
Paul M Peloso, MD, MSc.Study DirectorACELYRIN Inc.
1 Previous Clinical Trials
176 Total Patients Enrolled

Media Library

Izokibep (Interleukin-17A Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05384249 — Phase 2
Uveitis Research Study Groups: Group 1: Placebo subcutaneous once weekly, Group 2: Izokibep subcutaneous once weekly
Uveitis Clinical Trial 2023: Izokibep Highlights & Side Effects. Trial Name: NCT05384249 — Phase 2
Izokibep (Interleukin-17A Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384249 — Phase 2
Uveitis Patient Testimony for trial: Trial Name: NCT05384249 — Phase 2

Frequently Asked Questions

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

Are there any available openings for patients who wish to enroll in this clinical trial?

"The trial is still enrolling patients, according to the information provided on clinicaltrials.gov. This particular study was initially posted on 8/23/2022 and received its most recent update 11/1/2022."

Answered by AI

Who meets the requirements to enroll in this clinical trial?

"This study is looking for 120 individuals, aged 18 to 75, who currently suffer from uveitis. Furthermore, it is essential that potential patients meet the following requirements: Be able and willing to provide informed consent, be of legal age (18 or older), have a diagnosis of non-infectious intermediate-, posterior-, or pan-uveitis active enough to show visible inflammatory retinal lesions under examination by dilation indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and spectral domain optical coherence tomography (SD-OCT). There must also be evidence of ≥ 2+ vitre"

Answered by AI

Does this research project have sites in multiple states?

"This study is enrolling patients at 16 sites. The sites are located in Detroit, Los Angeles and Hagerstown as well as 14 other locations. It is important to select the clinic closest you to minimize travel demands if you enroll."

Answered by AI

How many people will be taking part in this experiment at most?

"That is accurate. The clinicaltrials.gov website does show that this research trial is currently looking for subjects to enroll. This experiment was originally posted on 8/23/2022 and has had 1 update, which occurred on 11/1/2022. There are a total of 120 spots available for volunteers at 16 different sites."

Answered by AI

Are there any life-threatening risks associated with taking Izokibep?

"As this is a Phase 2 trial, meaning that while there is some data supporting safety, none supports efficacy, our team at Power rates the safety of Izokibep as a 2."

Answered by AI

Does this research study limit its participants to those under 50 years old?

"The age limit for participants in this clinical trial is 75 years old. All patients that meet this criteria and are older than 18 years old are encouraged to enroll."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have reoccurring uveitis.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

- How frequently do I need to travel to the clinical site?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis
2022. "Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05384249.
All > Uveitis
~20 spots leftby Oct 2024
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