Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. This study investigates izokibep in subjects with active non-infectious, intermediate-, posterior- or pan-uveitis requiring high-dose steroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Time to treatment failure defined as reaching treatment failure by meeting ≥ 1 of the 4 criteria specified in the protocol in at least 1 eye.
Time frame: Up to Week 52
Change in best corrected visual acuity (BCVA) from best state achieved
Time frame: Before Week 10 to Week 24
Change in the National Eye Institute (NEI) Visual Function Questionnarie-25 (VFQ-25) score from best state achieved
Time frame: Before Week 10 to Week 24
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline to Week 10
Change in central retinal thickness by Spectral-Domain Optical Coherence Tomography (SD-OCT) from best state achieved
Time frame: Week 10 up to Week 52
Proportion of subjects that achieve quiescence
Time frame: Week 10
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline up to Follow-up (Week 65)
Incidence of serious adverse events (SAEs)
Time frame: Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in laboratory values
Time frame: Baseline up to Follow-up (Week 65)
Incidence of clinically significant changes in vital signs
Time frame: Baseline up to Follow-up (Week 65)
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