Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. Izokibep has been investigated in non-clinical and clinical studies including healthy subjects and patients with psoriasis and psoriatic arthritis and is currently being studied in uveitis, axial spondyloarthritis and hidradenitis suppurativa. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ACELYRIN Inc.

Criteria

Inclusion Criteria:

General

• Subject or legally authorized representative 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 intervention

• 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 intervention

• 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 intervention

Other protocol defined Inclusion/Exclusion criteria may apply