EUCTR2021-006498-49-DE进行中（未招募）1 期
A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep inSubjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
研究者
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