A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Non-infectious, Intermediate-, Posterior- or Pan-uveitis

  • STATUS
    Recruiting
  • End date
    Aug 22, 2024
  • participants needed
    120
  • sponsor
    ACELYRIN Inc.
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Updated on 22 October 2022
See if I qualify
angiography
corticosteroids
prednisone
fluorescein angiography
fundus photography
optical coherence tomography
retinal vascular

Summary

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. Izokibep has been investigated in non-clinical and clinical studies including healthy subjects and patients with psoriasis and psoriatic arthritis and is currently being studied in uveitis, axial spondyloarthritis and hidradenitis suppurativa. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

Details
Condition Uveitis
Treatment Placebo, Izokibep
Clinical Study IdentifierNCT05384249
SponsorACELYRIN Inc.
Last Modified on22 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

General
Subject or legally authorized representative 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
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 intervention
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 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
Other protocol defined Inclusion/Exclusion criteria may apply
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