Non-infectious, Intermediate-, Posterior- or Pan-uveitis MedDRA version: 22.1 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders MedDRA version: 20.1 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
ACELYRIN, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject(male and female) must be = 18 and = 75 years of age - 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: o 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). o = 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. - No known history of active tuberculosis (TB). - Subject has a negative TB test at screening, - Male and Female participants of childbearing potential must use effective methods of contraception For a complete overview of the inclusion criteria refer to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: - 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 - Planned (elective) eye surgery during the course of the study - History of prior refractive laser surgery, laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation), retinal laser photocoagulation, or neodymium-doped yttrium aluminum garnet posterior capsulotomy = 30 days before day 1 - History of any other prior ocular surgery = 3 months prior to day 1 except surgery for cosmetic reasons that is not expected to impact vision - 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 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 (eg, vitreomacular traction, epiretinal membranes) 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 - Active IBD within 3 years prior to enrollment - Active infection or history of infection - Candida infection requiring systemic treatment = 3 months prior to first dose of study drug - Uncontrolled, clinically significant system disease such as diabetes mellitus, hypertension, cardiovascular disease including moderate to severe heart failure (New York Heart Association class III/IV), moderate to severe renal disease, moderate to severe liver disease, as determined by investigator - History of demyelinating disease (including myelitis) or neurological symptoms suggestive of demyelinating disease - Malignancy within 5 years - History or evidence of any clinically significant disorder, condition, or disease that, in the opinion of the investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures or completion - Tuberculosis or fungal infection seen on available chest x-ray taken = 3 months of screening or at screening (Exception: documented evidence of completed treatment and clinically resolved) - Known history of human immunodeficiency virus (HIV). - Prior exposure to biologics that had a potential or known association with progressive multifocal leukoencephalopathy (ie, natalizumab [Tysabri®], rituximab [Rituxan®] or efalizumab [Raptiva®]) - Exposure to TNF-a inhibitors, IL-1, IL-12, IL-23, IL-12/23 receptor inhibitors or Janus kinase inhibitors within 5 half-lives prior to first dose of study drug - Positive hepatitis B surface antigen (HBsAg) or detected sensitivity on the hepatitis B virus DNA polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBcAb)/hepatitis B surface antibody (HBsAb) positive subjects OR positive hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that izokibep is efficacious compared to placebo, as measured by time to treatment failure occurring at or after week 10 and up to week 52;Secondary Objective: - To demonstrate that izokibep is efficacious, as measured by: • Proportion of subjects that achieve quiescence at week 10 • Change in BCVA from best state achieved before week 10 to week 24 • Change in the NEI VFQ-25 score from best state achieved before week 10 to week 24 • Change in central retinal thickness (by SD-OCT) from baseline to week 10 • Change in central retinal thickness (by SD-OCT) from best state achieved = week 10 up to week 52 -To assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of special interest, SAEs and clinically significant lab values and vital signs - To assess the immunogenicity of izokibep as measured by the presence of treatment-emergent ADAs;Primary end point(s): Time to treatment failure;Timepoint(s) of evaluation of this end point: At or after week 10 /time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quiescence - BCVA - NEI VFQ-25 - Central retinal thickness - TEAEs, events of special interest and SAEs - Laboratory values and vital signs - ADAs ;Timepoint(s) of evaluation of this end point: - Quiescence at week 10 - BCVA from best state achieved before week 10 to week 24 - NEI VFQ-25 score from best state achieved before week 10 to week 24 - Central retinal thickness (by SD-OCT) from baseline to week 10 - Central retinal thickness (by SD-OCT) from best state achieved = week 10 up to week 52 From start to end of study: - Incidence of TEAEs, events of special interest, SAEs - Laboratory values and vital signs at collected timepoints - ADAs | — |
Countries
Austria, Czechia, Czech Republic, France, Germany, Italy, Spain, United States
Contacts
Public ContactClinical Trial Information Desk
ACELYRIN, INC.
Outcome results
None listed