EUCTR2020-004964-25-IT进行中（未招募）1 期
A phase 2 trial of the efficacy and safety of the interleukin-17A inhibitor ABY-035 in the treatment and prevention of relapse/recurrence of non-infectious intermediate, posterior or pan-uveitis, including an initial pilot phase (LINNAEA) - LINNAEA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Affibody AB
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1] Signed informed consent and signed data protection declaration
- •2] >=18 years of age at SCR
- •3] Previously documented medical history with diagnosed unilateral or bilateral NIIPPU
- •4] 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:
- •a) active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion by dilated indirect ophthalmoscopy (DIO), fundus photography, and 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, fundus photography and/or SD-OCT is required to confirm eligibility).
- •b) >=2+ vitreous haze ( NEI/SUN criteria) by DIO and Fundus Photography (the central reader's assessment using Fundus Photography is required to confirm eligibility).
- •5] On treatment with oral corticosteroids (>=7 to <=40 mg/day oral prednisolone/pre dnisone or equivalent) at a stable dose for at least 2 weeks before BL
- •6] For females of non-childbearing potential: Post-menopausal or surgically sterile 7] For females of childbearing potential: Negative human chorionic gonadotropin (hCG) test at SCR visit AND practicing adequate contraception (see section 7.1.7) from SCR to FUpreg (section 6.2.6)
- •8] For males: if having a female partner, the partner should be of nonchildbearing potential (see inclusion criteria 6) OR using an adequate method of contraception (see section 7.1.7) from SCR to FUpreg (see 6.2.6)
- •9] Able and willing to comply with the trial directives (as per the investigator's judgment)
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1] History of hypersensitivity or allergy to ABY-035 or its excipients
- •2] History of hypersensitivity or allergy to fluorescein dye
- •3] Previous enrollment or randomization in the trial
- •4] Participation in another interventional clinical trial within 30 days before SCR or administration of another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is longer) before BL
- •5] Evidence or suspicion of social drug and/or alcohol abuse or dependence, according to the judgment of the investigator
- •6] Females who are currently pregnant, who intend to become pregnant during the trial, or who are breastfeeding
- •7] The subject is an investigator or belongs to the personnel of the trial site, the sponsor or involved service providers and/or their immediate families (partner, spouse, parent, child, or sibling, whether biological or legally adopted)
- •8] Subject with any medical or psychiatric condition which, in the investigator's opinion, would preclude the subject from adhering to the protocol or completing the clinical trial per protocol
- •9] The subject is considered to belong to a vulnerable population (e.g. placed under guardianship, imprisoned, other)
- •Criteria that relate to ocular conditions (and the etiology thereof)
- •10] Subject with isolated anterior uveitis
- •11] 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
- •12] 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
- •13] Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial
- •14] Planned (elective) eye surgery within 80 weeks after BL
- •15] History of prior refractive laser surgery, retinal laser photocoagulation, or neodymium-doped yttrium aluminium garnet posterior capsulotomy within 30 days before BL
- •16] History of any other prior ocular surgery within 90 days before BL
- •17] Subject with intraocular pressure (IOP) of >=25 mmHg while on >=2 glaucoma medications or evidence of glaucomatous optic nerve injury
- •18] Subject with severe vitreous haze that precludes visualization of the fundus at BL
- •19] Subject has a contraindication for mydriatic eye drops OR subject cannot be dilatated sufficiently well to permit good fundus visualization
- •20] Subject with BCVA <20 letters (ETDRS) in at least one eye at BL
- •21] 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
- •PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF EXCLUSION CRITERIA
研究者
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