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

Inclusion Criteria:

General

• Subject has provided signed informed consent including consenting to comply with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

• 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 atleast 1 eye despite treatment with stable doses of corticosteroids for at least 2weeks prior to day 1:

• Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesionby dilated indirect ophthalmoscopy, fundus photography, fluorescein angiography (FA), and Spectral-Domain Optical Coherence Tomography (SD-OCT) to determinewhether a lesion is active or inactive (the central reading center assessmentusing FA, fundus photography and/or SD-OCT is required to confirm eligibilityprior to day 1).

• ≥ 2+ vitreous haze (National Eye Institute [NEI]/Standardization of UveitisNomenclature [SUN] criteria) by digital indirect ophthalmoscope and fundusphotography (the central reading center assessment using fundus photography isrequired to confirm eligibility prior to day 1).

• Currently receiving treatment with oral corticosteroids (≥ 7.5 mg/day to ≤ 40 mg/dayoral prednisone/prednisolone or corticosteroid equivalent) at a stable dose for atleast 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 orthat likely requires cataract surgery during the duration of the study

• Subject with intraocular pressure of ≥ 25 mmHg while on ≥ 2 glaucoma medications orevidence of glaucomatous optic nerve injury

• Subject with severe vitreous haze that precludes visualization of the fundus priorto first dose of study drug

• Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatedsufficiently well to permit good fundus visualization

• Subject with best corrected visual acuity (BCVA) < 20 letters (Early TreatmentDiabetic Retinopathy Study [ETDRS]) in at least 1 eye prior to first dose of studydrug

• Subject with proliferative or severe non-proliferative retinopathy or clinicallysignificant 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 formacular 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/Exclusion criteria may apply