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
Study objective:
To assess the safety, tolerability, and immunogenicity of izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
Study design:
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.
Inclusion criteria:
- 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.
Exclusion criteria:
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- 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
Contact Kelly Boyd with questions: 608-265-4589.
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