non-infectious intermediate, posterior, or pan-uveitis MedDRA version: 20.0 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: ABY-035
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Izokibep
CAS Number: 2226130-02-3
Current Sponsor code: ABY-035
Other descriptive name: Recombinant protein compr
Sponsors
Affibody AB
Eligibility
Sex/Gender
All
Inclusion criteria
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, 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 non-childbearing 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Part B: To investigate the efficacy of ABY-035 in preventing relapse/recurrence in inactive uveitis from trial beyond W10 up to W50;Secondary Objective: • To evaluate the safety of ABY-035 • To characterize the exposure of ABY-035 in plasma • To assess the immunogenicity of ABY-035 • To investigate the efficacy of ABY-035 in treating active uveitis from BL up to W10;Primary end point(s): Part A: number and proportion of subjects with complete response at week 10 Part B: "Time to Treatment Failure" (TTF) beyond week 10;Timepoint(s) of evaluation of this end point: Part A: week 10 Part B: after week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: BL to W10 for Part A and W10 to W50 for Part B;Secondary end point(s): Secondary endpoints supporting the primary objectives for Part B (Efficacy) related to the preventive part (>W10): • Change in ACC grade from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier Change in vitreous haze grade (NEI/SUN criteria) from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier • Change in BCVA using logarithm of the minimum angle of resolution (logMAR) calculation from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier • Change in central retinal thickness (by SD-OCT) from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier • In subjects with excess CST (by SD-OCT) at BL: Change in the reduction of BL excess CST from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier • Change in the NEI VFQ-25 score from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier • Change in the EQ-5D-3L score from from best state achieved =W10 up to W50 or up to discontinuation due to Treatment Failure, if earlier Secondary endpoints (Efficacy) related to the treatment of active disease (=W10): • Change in ACC grade from BL to W10 or up to discontinuation due to Early Lack of Response, if earlier • Change in vitreous haze grade (NEI/SUN criteria) from BL to W10 or up to discontinuation due to Early Lack of Response, if earlier • Change in BCVA using logMAR calculation from BL to W10 or up to discontinuation due to Early Lack of Response, if earlier • Change in central retinal thickness (by SD-OCT) from BL to W10 or up to discontinuation due to Early Lack of Response, if earlier • Change of excess CST from BL to W10 or up to discontinuation due to Early Lack of Response, if earlier • Cha | — |
Countries
Austria, France, Germany, Italy, Spain, Switzerland, United States
Contacts
Public ContactRegulatory Affairs
Affibody AB
Outcome results
None listed