Phase I Study to Find the Safe Dose of F8IL10 Injected into Joints for Rheumatoid Arthritis Patients

What this Trial Is About

Researchers are evaluating the safety and tolerability of F8IL10 administered by intra-articular injection in patients with Rheumatoid Arthritis RA who experience arthritis flares despite stable treatment with disease-modifying anti-rheumatic drugs DMARDs. This phase I, open-label study aims to determine the maximum tolerated dose MTD and recommended dose RD of F8IL10 to inform future dosing strategies. The study involves sequential patient cohorts receiving escalating doses of F8IL10 to assess safety and tolerability. Participants will receive intra-articular injections of F8IL10 every 4 weeks for up to three doses. The study has two parts a dose escalation phase with increasing doses ranging from 25 to 1000 micrograms, followed by a dose expansion phase where 12 patients will receive the recommended dose identified during escalation. After treatment, patients will enter a follow-up period lasting up to 6 months to monitor response duration, health status, and any adverse events. During the study, participants will undergo various assessments including safety monitoring through adverse event tracking, laboratory tests, and injection site reaction evaluations up to 37 weeks. Measures of early efficacy like joint inflammation and disease activity indices will be assessed regularly. Pharmacokinetic and immunogenicity evaluations will also be performed. Participants will attend scheduled visits for injections and follow-up evaluations, with the study lasting several months from treatment start through follow-up.

A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis