A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Non-infectious, Intermediate-, Posterior- or Pan-uveitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514975-16-00

Acronym

21103

Enrollment

Registered

2024-08-19

Start date

2022-12-22

Completion date

2025-01-07

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-infectious, Intermediate-, Posterior- or Pan-uveitis

Brief summary

Time to treatment failure

Detailed description

• Quiescence • BCVA • NEI-VFQ-25 score • Central retinal thickness • Central retinal thickness • TEAEs, events of special interest and SAEs • Laboratory values and vital signs at collected timepoints • ADAs"

Interventions

DRUGThe ABY-035 Formulation Buffer (FB) 10 mM Sodium Phosphate

DRUG150 mM NaCl

DRUGand 0.5 mM EDTA at pH 7.0 is intended to be used for parenteral administration as Placebo of izokibep (ABY-035) in clinical trials.

DRUGIzokibep

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to treatment failure	—

Secondary

Measure	Time frame
• Quiescence • BCVA • NEI-VFQ-25 score • Central retinal thickness • Central retinal thickness • TEAEs, events of special interest and SAEs • Laboratory values and vital signs at collected timepoints • ADAs"	—

Countries

Austria, Czechia, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026