Status:
TERMINATED
Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis
Lead Sponsor:
ACELYRIN Inc.
Conditions:
Uveitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-i...
Eligibility Criteria
Inclusion
- General
- 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
- 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
Key Trial Info
Start Date :
August 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05384249
Start Date
August 23 2022
End Date
February 7 2025
Last Update
February 21 2025
Active Locations (69)
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1
Clinical Research Site
Phoenix, Arizona, United States, 85020-5505
2
Clinical Research Site
Bakersfield, California, United States, 93309
3
Clinical Research Site
Beverly Hills, California, United States, 90211-1841
4
Clinical Research Site
Los Angeles, California, United States, 90033-1036