Uveitis Clinical Trial
Official title:
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Non-infectious, Intermediate-, Posterior- or Pan-uveitis
Verified date | February 2024 |
Source | ACELYRIN Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 96 |
Est. completion date | August 7, 2025 |
Est. primary completion date | August 7, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 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 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Clinical Research Site | Graz | |
Austria | Clinical Research Site | Salzburg | |
Austria | Clinical Research Site | Vienna | |
Czechia | Clinical Research Site | Brno | |
Czechia | Clinical Research Site | Pardubice | |
Czechia | Clinical Research Site | Prague | |
Czechia | Clinical Research Site | Praha | |
France | Clinical Research Site | Lyon | |
France | Clinical Research Site | Marseille | |
France | Clinical Research Site | Paris | |
France | Clinical Research Site | Paris | |
France | Clinical Research Site | Paris | |
Germany | Clinical Research Site | Berlin | |
Germany | Clinical Research Site | Bonn | |
Germany | Clinical Research Site | Hamburg | |
Germany | Clinical Research Site | Kiel | |
Germany | Clinical Research Site | Leipzig | |
Germany | Clinical Research Site | Munster | |
Germany | Clinical Research Site | Münster | |
Italy | Clinical Research Site | Milan | |
Italy | Clinical Research Site | Milano | |
Italy | Clinical Research Site | Milano | |
Italy | Clinical Research Site | Reggio Emilia | |
Spain | 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 | |
United States | Clinical Research Site | Austin | Texas |
United States | Clinical Research Site | Bakersfield | California |
United States | Clinical Research Site | Bellaire | Texas |
United States | Clinical Research Site | Beverly Hills | California |
United States | Clinical Research Site | Charleston | South Carolina |
United States | Clinical Research Site | Clearwater | Florida |
United States | Clinical Research Site | Cleveland | Ohio |
United States | Clinical Research Site | Cleveland | Ohio |
United States | Clinical Research Site | Detroit | Michigan |
United States | Clinical Research Site | Erie | Pennsylvania |
United States | Clinical Research Site | Hagerstown | Maryland |
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 | Indianapolis | Indiana |
United States | Clinical Research Site | Lakewood | Colorado |
United States | Clinical Research Site | Los Angeles | California |
United States | Clinical Research Site | Los Angeles | California |
United States | Clinical Research Site | Madison | Wisconsin |
United States | Clinical Research Site | Marietta | Georgia |
United States | Clinical Research Site | Nashville | Tennessee |
United States | Clinical Research Site | New York | New York |
United States | Clinical Research Site | Oak Park | Illinois |
United States | Clinical Research Site | Palisades Park | New Jersey |
United States | Clinical Research Site | Palo Alto | California |
United States | Clinical Research Site | Pasadena | California |
United States | Clinical Research Site | Phoenix | Arizona |
United States | Clinical Research Site | Pittsburgh | Pennsylvania |
United States | Clinical Research Site | Plano | Texas |
United States | Clinical Research Site | Portland | Oregon |
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 | Spokane | Washington |
United States | Clinical Research Site | Waltham | Massachusetts |
United States | Clinical Research Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
ACELYRIN Inc. |
United States, Austria, Czechia, France, Germany, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to treatment failure defined as reaching treatment failure by meeting = 1 of the 4 criteria specified in the protocol in at least 1 eye. | Week 10 and up to Week 52 | ||
Secondary | Proportion of subjects that achieve quiescence | Week 10 | ||
Secondary | Change in best corrected visual acuity (BCVA) from best state achieved | Before Week 10 to Week 24 | ||
Secondary | Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved | Before Week 10 to Week 24 | ||
Secondary | Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) | Baseline to Week 10 | ||
Secondary | Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved | Week 10 up to Week 52 | ||
Secondary | Incidence of treatment-emergent adverse events (TEAEs) | Baseline up to Follow-up (Week 65) | ||
Secondary | Incidence of serious adverse events (SAEs) | Baseline up to Follow-up (Week 65) | ||
Secondary | Incidence of clinically significant changes in laboratory values | Baseline up to Follow-up (Week 65) | ||
Secondary | Incidence of clinically significant changes in vital signs | Baseline up to Follow-up (Week 65) |
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