Phase 2b Pivotal Study of Izokibep in Non-infectious, Intermediate-, Posterior- or Pan-uveitis
NCT ID: NCT05384249
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
96 participants
INTERVENTIONAL
2022-08-23
2025-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Placebo subcutaneous once weekly
Participants will receive placebo every week to week 51.
Placebo
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Group 2: Izokibep subcutaneous once weekly
Participants will receive izokibep every week to week 51.
Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Interventions
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Izokibep
Biologic: IL-17A inhibitor
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Placebo
Form: Solution for injection
Route of administration: Subcutaneous (SC)
Eligibility Criteria
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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
* 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
18 Years
75 Years
ALL
No
Sponsors
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ACELYRIN Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Betah
Role: STUDY_DIRECTOR
ACELYRIN Inc.
Locations
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Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Bakersfield, California, United States
Clinical Research Site
Beverly Hills, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Palo Alto, California, United States
Clinical Research Site
Pasadena, California, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Sacramento, California, United States
Clinical Research Site
San Francisco, California, United States
Clinical Research Site
Denver, Colorado, United States
Clinical Research Site
Clearwater, Florida, United States
Clinical Research Site
Marietta, Georgia, United States
Clinical Research Site
Oak Park, Illinois, United States
Clinical Research Site
Indianapolis, Indiana, United States
Clinical Research Site
Hagerstown, Maryland, United States
Clinical Research Site
Waltham, Massachusetts, United States
Clinical Research Site
Detroit, Michigan, United States
Clinical Research Site
Palisades Park, New Jersey, United States
Clinical Research Site
New York, New York, United States
Clinical Research Site
Winston-Salem, North Carolina, United States
Clinical Research Site
Cleveland, Ohio, United States
Clinical Research Site
Cleveland, Ohio, United States
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Portland, Oregon, United States
Clinical Research Site
Erie, Pennsylvania, United States
Clinical Research Site
Pittsburgh, Pennsylvania, United States
Clinical Research Site
Charleston, South Carolina, United States
Clinical Research Site
Nashville, Tennessee, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Bellaire, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
Plano, Texas, United States
Clinical Research Site
Spokane, Washington, United States
Clinical Research Site
Madison, Wisconsin, United States
Clinical Research Site
Graz, , Austria
Clinical Research Site
Salzburg, , Austria
Clinical Research Site
Vienna, , Austria
Clinical Research Site
Brno, , Czechia
Clinical Research Site
Pardubice, , Czechia
Clinical Research Site
Prague, , Czechia
Clinical Research Site
Prague, , Czechia
Clinical Research Site
Lyon, , France
Clinical Research Site
Marseille, , France
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Paris, , France
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Paris, , France
Clinical Research Site
Paris, , France
Clinical Research Site
Berlin, , Germany
Clinical Research Site
Bonn, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
Clinical Research Site
Münster, , Germany
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Münster, , Germany
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Milan, , Italy
Clinical Research Site
Milan, , Italy
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Milan, , Italy
Clinical Research Site
Reggio Emilia, , Italy
Clinical Research Site
Barcelona, , Spain
Clinical Research Site
Barcelona, , Spain
Clinical Research Site
Barcelona, , Spain
Clinical Research Site
Barcelona, , Spain
Clinical Research Site
Madrid, , Spain
Clinical Research Site (4007)
Santiago de Compostela, , Spain
Clinical Research Site (4008)
Santiago de Compostela, , Spain
Clinical Research Site
Valencia, , Spain
Clinical Research Site
Zaragoza, , Spain
Clinical Research Site
Zaragoza, , Spain
Countries
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Other Identifiers
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2024-514975-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
21103
Identifier Type: -
Identifier Source: org_study_id
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