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

Phase 2

Active, not recruiting

• Conditions: Uveitis
• Interventions: Drug: Placebo; Drug: Izokibep

• Registration Number: NCT05384249
• Lead Sponsor: ACELYRIN Inc.

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-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations
|
Related News

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Study Start: 2022-08-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-08-07
• Study Completion: 2025-08-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Placebo subcutaneous once weekly	Placebo	Participants will receive placebo every week to week 51.
Group 2: Izokibep subcutaneous once weekly	Izokibep	Participants will receive izokibep every week to week 51.

Primary Outcome Measures

Name	Time	Method
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.	Up to Week 52

Secondary Outcome Measures

Name	Time	Method
Change in best corrected visual acuity (BCVA) from best state achieved	Before Week 10 to Week 24
Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved	Before Week 10 to Week 24
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)	Baseline to Week 10
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved	Week 10 up to Week 52
Proportion of subjects that achieve quiescence	Week 10
Incidence of treatment-emergent adverse events (TEAEs)	Baseline up to Follow-up (Week 65)
Incidence of serious adverse events (SAEs)	Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in laboratory values	Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in vital signs	Baseline up to Follow-up (Week 65)

Trial Locations

Locations (3)

Clinical Research Site; 🇪🇸 Zaragoza, Spain

Clinical Research Site (4007); 🇪🇸 Santiago De Compostela, Spain

Clinical Research Site (4008); 🇪🇸 Santiago De Compostela, Spain