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.
- Conditions
- non-infectious intermediate, posterior, or pan-uveitisMedDRA version: 20.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-004964-25-DE
- Lead Sponsor
- Affibody AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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 and/or 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 FU PK/ADA/preg (section 6.2.6)
8] For males: if having a female partner, the partner should be of non-childbearing potential (see
inclusion criteria 6) OR using an adequate method of contraception (see section 7.1.7) from SCR to
FU PK/ADA/preg (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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
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
22] Subject with proliferative or severe non-proliferative diabetic retinopathy or clinically significant
macular edema due to diabetic retinopathy
23] Subject with neovascular/wet age-related macular degeneration
24] Subject with an abnormality of the vitreo-retinal interface (i.e., vitreomacular traction, epiretinal
membranes, etc.) with the potential for macular structural damage independent of the inflammatory
process
25] Subject with a history of active scl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method