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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384249
• Other study ID #: 21103
• Secondary ID: 2021-006498-49
• Status: Recruiting
• Phase: Phase 2
• Start date: August 23, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: ACELYRIN Inc.
• Contact: Donald Betah
• Phone: 805-730-0327
• Email: clinicaltrials[@]acelyrin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• 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

Related Conditions & MeSH terms

• Panuveitis
• Uveitis

Intervention

Drug:
• Izokibep
Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)
• Placebo
Form: Solution for injection Route of administration: Subcutaneous (SC)

Locations

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 Orleans	Louisiana
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

Sponsors (1)

Lead Sponsor	Collaborator
ACELYRIN Inc.

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  France,  Germany,  Italy,  Spain, 

Outcome

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)