Open Actively Recruiting

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


Brief Summary

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age
75 Years

Inclusion Criteria:


  • Subject 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 drug
  • 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 drug
  • 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 drug

Other protocol defined Inclusion/Exclusion criteria may apply

Join this Trial

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Study Stats
Protocol No.
Eye/Ocular Disorders
Principal Investigator
Joseph Privratsky
  • UCLA Westwood
For Providers
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