Actively Recruiting // Clinical Trials // Laura Kopplin // Non-Infectious // Uveitis // Oct 07 2022
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis
Sponsor: ACELYRIN Inc.
Principal Investigator: Laura Kopplin, MD, PhD
Study Coordinator: Kelly Boyd
To assess the safety, tolerability, and immunogenicity of izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
The study consists of a 28-day screening period, a 51-week treatment period and a follow-up period with visits at 8 weeks and 14 weeks after the last dose of study intervention to assess safety and immunogenicity. Eligible subjects will be randomized into 1 of 4 groups in a 1:1:2:2 ratio as follows: Group 1: placebo SC QW, Group 2: placebo SC Q2W, Group 3: izokibep SC 160 mg QW, Group 4: izokibep SC 160 mg Q2W.
18 years to 75 years of age
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.
Subject with isolated anterior uveitis
Subject with serpiginous choroidopathy
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 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