EUCTR2020-004964-25-DE
Active, not recruiting
Phase 1
A phase 2 trial of the efficacy and safety of the interleukin-17A inhibitor ABY-035 inthe treatment and prevention of relapse/recurrence of non-infectious intermediate,posterior or pan-uveitis (LINNAEA) - LINNAEA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- non-infectious intermediate, posterior, or pan-uveitis
- Sponsor
- Affibody AB
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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).
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
Outcomes
Primary Outcomes
Not specified
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