A Phase 2 interventional study of Izokibep and Placebo in Uveitis, sponsored by ACELYRIN Inc.. Terminated at 69 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by ACELYRIN Inc. · Phase 2, Interventional, and Treatment
Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 96 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →ACELYRIN Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General
Type of Subject and Disease Characteristics
Active disease defined by the presence of at least 1 of the following criteria in at least 1 eye despite treatment with stable doses of for at least 2 weeks prior to day 1:
Exclusion Criteria:
Disease-related Medical Conditions
Other protocol defined Inclusion/Exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo every week to week 51.
Drug: Placebo
Participants will receive izokibep every week to week 51.
Drug: Izokibep
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
Form: Solution for injection Route of administration: Subcutaneous (SC)
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.
Time frame: Up to Week 52
Change in best corrected visual acuity (BCVA) from best state achieved
Time frame: Before Week 10 to Week 24
Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved
Time frame: Before Week 10 to Week 24
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline to Week 10
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved
Time frame: Week 10 up to Week 52
Proportion of subjects that achieve quiescence
Time frame: Week 10
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline up to Follow-up (Week 65)
Incidence of serious adverse events (SAEs)
Time frame: Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in laboratory values
Time frame: Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in vital signs
Time frame: Baseline up to Follow-up (Week 65)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Izokibep
ACELYRIN Inc.