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

Affibody AB0 sites110 target enrollmentOctober 18, 2021

Conditionsnon-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]

DrugsDecortin H

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: non-infectious intermediate, posterior, or pan-uveitis
Sponsor: Affibody AB
Enrollment: 110
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Affibody AB

Eligibility 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, 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)

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)