UveitisPhase 2NCT05384249

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

A Phase 2 study testing Izokibep in people with Uveitis, run by ACELYRIN Inc. at 69 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Uveitis
What is being tested?: Izokibep
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 69 sitesin 7 countries
Study dates: 23 Aug 2022to 7 Feb 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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.

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

69 sites in 7 countries.

Country

City, postcode or hospital

69 sites in 7 countries

United States36 sites

Clinical Research Site
Austin, Texas, 78714
Clinical Research Site
Bakersfield, California, 93309
Clinical Research Site
Bellaire, Texas, 77401-3218
Clinical Research Site
Beverly Hills, California, 90211-1841
Clinical Research Site
Charleston, South Carolina, 29414
Clinical Research Site
Clearwater, Florida, 33761
Clinical Research Site
Cleveland, Ohio, 44106
Clinical Research Site
Cleveland, Ohio, 44195-0001
Clinical Research Site
Denver, Colorado, 80246
Clinical Research Site
Detroit, Michigan, 48201-1423
Clinical Research Site
Erie, Pennsylvania, 16507-1429
Clinical Research Site
Hagerstown, Maryland, 21740-5940
Clinical Research Site
Houston, Texas, 77025-1756
Clinical Research Site
Houston, Texas, 77030
Clinical Research Site
Houston, Texas, 77494-3286
Clinical Research Site
Indianapolis, Indiana, 46290
Clinical Research Site
Los Angeles, California, 90033-1036
Clinical Research Site
Los Angeles, California, 90095-7065
Clinical Research Site
Madison, Wisconsin, 53705-3644
Clinical Research Site
Marietta, Georgia, 30060-8935
Clinical Research Site
Nashville, Tennessee, 37232
Clinical Research Site
New York, New York, 10003
Clinical Research Site
Oak Park, Illinois, 60304-1096
Clinical Research Site
Palisades Park, New Jersey, 07650-2322
Clinical Research Site
Palo Alto, California, 94303
Clinical Research Site
Pasadena, California, 91107-3747
Clinical Research Site
Phoenix, Arizona, 85020-5505
Clinical Research Site
Pittsburgh, Pennsylvania, 15213
Clinical Research Site
Plano, Texas, 75075-5025
Clinical Research Site
Portland, Oregon, 97239
Clinical Research Site
Redlands, California, 92373
Clinical Research Site
Sacramento, California, 95825
Clinical Research Site
San Francisco, California, 94109
Clinical Research Site
Spokane, Washington, 99204-2509
Clinical Research Site
Waltham, Massachusetts, 02451
Clinical Research Site
Winston-Salem, North Carolina, 27157

Other trials in United States

Spain10 sites

Clinical Research Site
Barcelona, 8017
Clinical Research Site
Barcelona, 8028
Clinical Research Site
Barcelona, 835
Clinical Research Site
Barcelona, 8907
Clinical Research Site
Madrid, 28040
Clinical Research Site (4007)
Santiago de Compostela, 15706
Clinical Research Site (4008)
Santiago de Compostela, 15706
Clinical Research Site
Valencia, 46015
Clinical Research Site
Zaragoza, 28040
Clinical Research Site
Zaragoza, 50009

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Germany7 sites

Clinical Research Site
Berlin, 13355
Clinical Research Site
Bonn, 53127
Clinical Research Site
Hamburg, 20246
Clinical Research Site
Kiel, 24105
Clinical Research Site
Leipzig, 4103
Clinical Research Site
Münster, 48145
Clinical Research Site
Münster, 48149

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France5 sites

Clinical Research Site
Lyon, 69004
Clinical Research Site
Marseille, 13008
Clinical Research Site
Paris, 75013
Clinical Research Site
Paris, 75014
Clinical Research Site
Paris, 75019

Other trials in France

Czechia4 sites

Clinical Research Site
Brno, 625 00
Clinical Research Site
Pardubice, 530 02
Clinical Research Site
Prague, 128 08
Clinical Research Site
Prague, 140 52

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Italy4 sites

Clinical Research Site
Milan, 20122
Clinical Research Site
Milan, 20132
Clinical Research Site
Milan, 20157
Clinical Research Site
Reggio Emilia, 42123

Other trials in Italy

Austria3 sites

Clinical Research Site
Graz, 8036
Clinical Research Site
Salzburg, 5020
Clinical Research Site
Vienna, 1090

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About this study

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

Conditions: Uveitis
Being tested: Izokibep, Placebo
Keywords: Non-infectious uveitis, Intermediate-uveitis, Posterior-uveitis, Pan-uveitis
Medical subject headings: Uveitis, Uveitis, Intermediate, Uveitis, Posterior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05384249
Study group	Role	What they receive
Group 1: Placebo subcutaneous once weekly	Placebo comparator	Participants will receive placebo every week to week 51. Receives: Drug: Placebo
Group 2: Izokibep subcutaneous once weekly	Experimental	Participants will receive izokibep every week to week 51. Receives: Drug: Izokibep

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Week 52

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 20227 Feb 2025

First posted20 May 2022
Study start23 Aug 2022
Primary completion7 Feb 2025
Study completion7 Feb 2025

Why it stopped: Study primary and secondary endpoints did not achieve statistical significance.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for UveitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05384249
Sponsor's protocol ID: 21103
Other IDs: 2024-514975-16-00
Status last verified: Feb 2025
First submitted: 17 May 2022
Last updated: 21 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
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RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
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All Uveitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05384249
Acronym / sponsor ID: 21103
Conditions: Uveitis
Keywords: Non-infectious uveitis, Intermediate-uveitis, Posterior-uveitis, Pan-uveitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study primary and secondary endpoints did not achieve statistical significance.
Enrolment: 96 participants (actual)
Lead sponsor: ACELYRIN Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2022 (actual)
Primary completion: 7 Feb 2025 (actual)
Study completion: 7 Feb 2025 (actual)
First posted: 20 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1: Placebo subcutaneous once weekly	Placebo comparator	Drug: PlaceboParticipants will receive placebo every week to week 51.
Group 2: Izokibep subcutaneous once weekly	Experimental	Drug: IzokibepParticipants will receive izokibep every week to week 51.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IzokibepBiologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)	Drug	Group 2: Izokibep subcutaneous once weekly
PlaceboForm: Solution for injection Route of administration: Subcutaneous (SC)	Drug	Group 1: Placebo subcutaneous once weekly

Primary outcome

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.
Time frame: Up to Week 52

9 secondary outcomes

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

Results and safety

The study was stopped early (reason given: Study primary and secondary endpoints did not achieve statistical significance.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Individual participant dataSharing planned: Undecided

Related trials for Uveitis

RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruiting
Efficacy and Safety of Adalimumab for the Treatment of Ocular Inflammation
Non-infectious Anterior Uveitis, Non-infectious Intermediate Uveitis
RecruitingObservational study
A Study of Uveitis in Children <18 Years of Age
Uveitis
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
RecruitingPhase 1
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
Non Infectious Uveitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donald Betah study director

ACELYRIN Inc.

69 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Izokibep in people with Uveitis, run by ACELYRIN Inc. at 69 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Spain, Germany, France, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study primary and secondary endpoints did not achieve statistical significance.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384249.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.