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

NCT05384249 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: 211032024-514975-16-00
• Study Type: interventional
• Target: 96
• Locations: 7 countries
• Sites: 69

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.

Conditions

Uveitis

Keywords

Non-infectious uveitis; Intermediate-uveitis; Posterior-uveitis; Pan-uveitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Group 1: Placebo subcutaneous once weekly

PLACEBO COMPARATOR

Participants will receive placebo every week to week 51.

Drug: Placebo

Group 2: Izokibep subcutaneous once weekly

EXPERIMENTAL

Participants will receive izokibep every week to week 51.

Drug: Izokibep

Interventions

Izokibep DRUG

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

Group 2: Izokibep subcutaneous once weekly

Placebo DRUG

Form: Solution for injection Route of administration: Subcutaneous (SC)

Group 1: Placebo subcutaneous once weekly

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ACELYRIN Inc.: lead

Study Sites (69)

Clinical Research Site

Phoenix, Arizona, 85020-5505, United States

Location

Clinical Research Site

Bakersfield, California, 93309, United States

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Clinical Research Site

Beverly Hills, California, 90211-1841, United States

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Clinical Research Site

Los Angeles, California, 90033-1036, United States

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Los Angeles, California, 90095-7065, United States

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Palo Alto, California, 94303, United States

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Clinical Research Site

Pasadena, California, 91107-3747, United States

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Redlands, California, 92373, United States

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Sacramento, California, 95825, United States

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San Francisco, California, 94109, United States

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Denver, Colorado, 80246, United States

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Clearwater, Florida, 33761, United States

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Marietta, Georgia, 30060-8935, United States

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Oak Park, Illinois, 60304-1096, United States

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Indianapolis, Indiana, 46290, United States

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Hagerstown, Maryland, 21740-5940, United States

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Waltham, Massachusetts, 02451, United States

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Detroit, Michigan, 48201-1423, United States

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Palisades Park, New Jersey, 07650-2322, United States

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New York, New York, 10003, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195-0001, United States

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Portland, Oregon, 97239, United States

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Erie, Pennsylvania, 16507-1429, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Charleston, South Carolina, 29414, United States

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Nashville, Tennessee, 37232, United States

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Austin, Texas, 78714, United States

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Clinical Research Site

Bellaire, Texas, 77401-3218, United States

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Houston, Texas, 77025-1756, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77494-3286, United States

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Plano, Texas, 75075-5025, United States

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Spokane, Washington, 99204-2509, United States

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Madison, Wisconsin, 53705-3644, United States

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Graz, 8036, Austria

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Salzburg, 5020, Austria

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Vienna, 1090, Austria

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Brno, 625 00, Czechia

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Pardubice, 530 02, Czechia

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Prague, 128 08, Czechia

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Clinical Research Site

Prague, 140 52, Czechia

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Lyon, 69004, France

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Marseille, 13008, France

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Paris, 75013, France

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Paris, 75014, France

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Paris, 75019, France

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Berlin, 13355, Germany

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Bonn, 53127, Germany

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Hamburg, 20246, Germany

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Kiel, 24105, Germany

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Leipzig, 4103, Germany

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Münster, 48145, Germany

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Clinical Research Site

Münster, 48149, Germany

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Clinical Research Site

Milan, 20122, Italy

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Clinical Research Site

Milan, 20132, Italy

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Clinical Research Site

Milan, 20157, Italy

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Clinical Research Site

Reggio Emilia, 42123, Italy

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Clinical Research Site

Barcelona, 8017, Spain

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Clinical Research Site

Barcelona, 8028, Spain

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Clinical Research Site

Barcelona, 835, Spain

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Clinical Research Site

Barcelona, 8907, Spain

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Clinical Research Site

Madrid, 28040, Spain

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Clinical Research Site (4007)

Santiago de Compostela, 15706, Spain

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Clinical Research Site (4008)

Santiago de Compostela, 15706, Spain

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Clinical Research Site

Valencia, 46015, Spain

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Clinical Research Site

Zaragoza, 28040, Spain

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Clinical Research Site

Zaragoza, 50009, Spain

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MeSH Terms

Conditions

Uveitis; Uveitis, Intermediate; Uveitis, Posterior

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Panuveitis

Study Officials

• Donald Betah

  ACELYRIN Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: August 23, 2022
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

DE (7); IT (4); ES (10); AU (3); CZ (4); US (36); FR (5)