A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis (NCT04706741) | Clinical Trial Compass
CompletedPhase 2
A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis
United States7 participantsStarted 2022-01-06
Plain-language summary
This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age at SCR
✓. Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
✓. Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids for at least 2 weeks:
✓. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by Dilated Indirect Ophthalmoscopy (DIO), Fundus Photography, Fluorescein angiography (FA), spectral-domain optical coherence tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reader's assessment using FA, FP, and or SD-OCT is required to confirm eligibility).
✓. ≥2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
✓. On treatment with oral corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent) at a stable dose for at least 2 weeks before BL
Exclusion criteria
✕. Subject with isolated anterior uveitis
✕. Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome, Punctate Inner Choroiditis or serpiginous choroidopathy
✕. Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
✕. Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
✕. Planned (elective) eye surgery within 80 weeks after BL
✕. History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
✕. History of any other prior ocular surgery within 90 days before BL
✕. Subject with intraocular pressure (IOP) of ≥25 mmHg while on ≥2 glaucoma medications or evidence of glaucomatous optic nerve injury