drugset
drugset / Trial / NCT05622175

Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment

NCT05622175 ↗

Phase 1 Withdrawn Philogen S.p.A.
NaSequentialOpen-labelTreatment

Summary

This multicenter, prospective Phase I study is aimed at testing the safety of F8IL10 via i.a. administration once every 4 weeks over 8 weeks in patients with RA who, despite treatment with stable doses (at least 3 months) of DMARDs (conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for i.a. injections.

Timeline

Start
2023-03-31
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject F8IL10 Monoclonal antibody 0.5 mg Other
Subject F8IL10 Monoclonal antibody 1 mg Other
Subject F8IL10 Monoclonal antibody 2.5 mg Other
Subject F8IL10 Monoclonal antibody 5 mg Other
Subject F8IL10 Monoclonal antibody 10 mg Other

Indications

rheumatoid arthritis