A Trial of the Efficacy and Safety of Izokibep in the Treatment of Non-anterior Uveitis

NCT04706741 | Completed Phase 2 FDA Drug

• 1 other identifier: ABY-035-203
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicenter, phase 2 trial to explore the efficacy and safety of Izokibep (ABY-035) in treating disease activity in patients with non-Infectious Intermediate, Posterior, Pan-Uveitis with significant disease activity at BL despite treatment with stable doses of corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent).

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

• Complete Response

  Complete Response is defined as Yes/No by visit by meeting at least 1 of the following criteria in at least one eye: 1. Inflammatory, chorioretinal and/or inflammatory retinal vascular lesions - No such active lesions; all prior lesions appear inactive 2. ACC Count - Trace or absent (0.5+ or 0) 3. Vitreous Haze - Trace or absent (0.5+ or 0)

  BL to Week 10

Study Arms (1)

Izokibep and maintenance corticosteroid dose

EXPERIMENTAL

Izokibep+ Prednisolon/Prednisone

Drug: Izokibep; Drug: Prednisone/Prednisolone

Interventions

Izokibep DRUG

Izokibep is an Interleukin-17 Inhibitor that will be administered subcutaneously

Also known as: ABY-035

Izokibep and maintenance corticosteroid dose

Prednisone/Prednisolone DRUG

Background Corticosteroid

Also known as: Prednisone

Izokibep and maintenance corticosteroid dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age at SCR
• Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
• Active disease at BL defined by the presence of at least 1 of the following criteria in at least one eye despite treatment with stable doses of corticosteroids for at least 2 weeks:
• Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by Dilated Indirect Ophthalmoscopy (DIO), Fundus Photography, Fluorescein angiography (FA), spectral-domain optical coherence tomography (SD-OCT) to determine whether a lesion is active or inactive (the central reader's assessment using FA, FP, and or SD-OCT is required to confirm eligibility).
• ≥2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
• On treatment with oral corticosteroids (≥7 to ≤40 mg/day oral prednisolon or equivalent) at a stable dose for at least 2 weeks before BL

You may not qualify if:

• Subject with isolated anterior uveitis
• Subject with Occlusive Behçet's disease, Acute Posterior Multifocal Placoid Pigment Epitheliopathy, Acute Posterior Pigment Epithelitis, Multiple Evanescent White Dot Syndrome, Punctate Inner Choroiditis or serpiginous choroidopathy
• Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, syphilis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 infection, Whipple's disease, herpes zoster virus, and herpes simplex virus
• Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
• Planned (elective) eye surgery within 80 weeks after BL
• History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
• History of any other prior ocular surgery within 90 days before BL
• Subject with intraocular pressure (IOP) 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 at BL
• Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently well to permit good fundus visualization
• Subject with BCVA \<20 letters (ETDRS) in at least one eye at BL
• Subject with intermediate uveitis or panuveitis who has presence or history of whitish exudates on the inferior pars plana (snowbanking) or vitreal inflammatory aggregates (snowballs) in combination with a medical history or signs or symptoms suggestive of a demyelinating disease such as multiple sclerosis
• Subject with proliferative or severe non-proliferative diabetic 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 (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process

Sponsors & Collaborators

• ACELYRIN Inc.: lead

Study Sites (4)

Research Site

Los Angeles, California, 90211, United States

Location

Research Site

Palo Alto, California, 94303, United States

Location

Research Site

Hagerstown, Maryland, 21740, United States

Location

Research Site

Plano, Texas, 75075, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols

Study Officials

• Donald Betah, MD

  ACELYRIN Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The primary purpose of the study is treatment of active Noninfectious Intermediate, Posterior or Pan-uveitis The study includes one treatment arm, into which 10 patients are planned to be enrolled

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: January 6, 2022
• Primary Completion: August 25, 2022
• Study Completion: November 14, 2022
• Last Updated: February 12, 2024

Record last verified: 2023-08

Locations

US (4)