NCT05622175

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

A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	F8IL10	The study consists of a dose escalation of F8IL10 to determine the MTD and the RD when administered intra-articular. Patients with arthritis flare(s) in "large joints" (shoulders, elbows, knees and ankles, with the exception of hip) and "small joints" (metacarpophalangeal joints, proximal interphalangeal joints, second through fifth metatarsal-phalangeal joints, thumb interphalangeal joints, and wrists) defined as per "2010 Rheumatoid Arthritis Classification Criteria" \[1\] will be treated with increasing dose of F8IL10 according to the schedule detailed below: Cohort 1: 0.5 mg F8IL10 Cohort 2: 1 mg F8IL10 Cohort 3: 2.5 mg F8IL10 Cohort 4: 5 mg F8IL10 Cohort 5: 10 mg F8IL10

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-11-18
• Last updated: 2025-12-02