Uveitis
Conditions
Keywords
Non-infectious uveitis, Intermediate-uveitis, Posterior-uveitis, Pan-uveitis
Brief summary
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.
Interventions
DRUGIzokibep
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
DRUGPlacebo
Form: Solution for injection Route of administration: Subcutaneous (SC)
Sponsors
ACELYRIN Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General * 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. * 18 years to 75 years of age Type of Subject and Disease Characteristics * Subject is diagnosed with non-infectious intermediate-, posterior- or pan-uveitis * 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 corticosteroids for at least 2 weeks prior to day 1: * Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and Spectral-Domain Optical Coherence Tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reading center assessment using FA, fundus photography and/or SD-OCT is required to confirm eligibility prior to day 1). * ≥ 2+ vitreous haze (National Eye Institute \[NEI\]/Standardization of Uveitis Nomenclature \[SUN\] criteria) by digital indirect ophthalmoscope and fundus photography (the central reading center assessment using fundus photography is required to confirm eligibility prior to day 1). * Currently receiving treatment with oral corticosteroids (≥ 7.5 mg/day to ≤ 40 mg/day oral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for at least 2 weeks prior to day 1.
Exclusion criteria
Disease-related Medical Conditions * Subject with isolated anterior uveitis * Subject with serpiginous choroidopathy * Subject with confirmed or suspected infectious uveitis * Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the study * Subject with intraocular pressure of ≥ 25 mmHg while on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury * Subject with severe vitreous haze that precludes visualization of the fundus prior to first dose of study drug * Subject has a contraindication for mydriatic eye drops OR subject cannot be dilated sufficiently well to permit good fundus visualization * Subject with best corrected visual acuity (BCVA) \< 20 letters (Early Treatment Diabetic Retinopathy Study \[ETDRS\]) in at least 1 eye prior to first dose of study drug * Subject with proliferative or severe non-proliferative retinopathy or clinically significant macular edema due to diabetic retinopathy * Subject with neovascular/wet age-related macular degeneration * Subject with an abnormality of the vitreo-retinal interface with the potential for macular structural damage independent of the inflammatory process * Subject with a history of active scleritis ≤ 12 months of first dose of study drug Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Up to Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved | Before Week 10 to Week 24 |
| Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) | Baseline to Week 10 |
| Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved | Week 10 up to Week 52 |
| Proportion of subjects that achieve quiescence | Week 10 |
| Change in best corrected visual acuity (BCVA) from best state achieved | Before Week 10 to Week 24 |
| Incidence of serious adverse events (SAEs) | Baseline up to Follow-up (Week 65) |
| Incidence of clinically significant changes in laboratory values | Baseline up to Follow-up (Week 65) |
| Incidence of clinically significant changes in vital signs | Baseline up to Follow-up (Week 65) |
| Incidence of treatment-emergent adverse events (TEAEs) | Baseline up to Follow-up (Week 65) |
Countries
Austria, Czechia, France, Germany, Italy, Spain, United States
Outcome results
None listed