Multinational, multicenter, phase 2 study of the efficacy and safety of ABY-035 in treating and preventing relapse/recurrence of disease activity in subjects with non-infectious intermediate, posterior or pan-uveitis.

Phase 1

Conditions: non-infectious intermediate, posterior, or pan-uveitis
MedDRA version: 20.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2020-004964-25-IT

Lead Sponsor: Affibody AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part A: To evaluate the efficacy of ABY-035 in treating active uveitis from Baseline (BL) up to week 10 (W10) with subsequent possible adaptation of the design in Part B<br>Part B: To investigate the efficacy of ABY-035 in preventing relapse/recurrence in inactive uveitis from trial beyond W10 up to W5;Secondary Objective: To evaluate the safety of ABY-035<br>To characterize the exposure of ABY-035 in plasma<br>To assess the immunogenicity of ABY-035<br>To investigate the efficacy of ABY-035 in treating active uveitis from BL up to W10;Primary end point(s): Part A: Numero e percentuale di soggetti con risposta completa alla S10 <br>Part B: tempo al fallimento del trattamento (Time to Treatment Failure, TTF) dopo la S10);Timepoint(s) of evaluation of this end point: Part A: week 10<br>Part B: after week 10

Secondary Outcome Measures

Name	Time	Method

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