RecruitingPhase 1NCT07245992

A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

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


Sponsor

Philogen S.p.A.

Enrollment

42 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial tests F8IL10, a new drug that delivers an anti-inflammatory protein (interleukin-10) directly into inflamed joints, as a treatment for rheumatoid arthritis. Rather than suppressing the entire immune system, this targeted approach aims to reduce joint inflammation locally with fewer whole-body side effects. **You may be eligible if...** - You are 18 to 80 years old - You have a confirmed rheumatoid arthritis (RA) diagnosis for more than 6 months - You have active joint flare(s) in a knee, ankle, shoulder, wrist, or elbow that are suitable for an injection, despite your current treatment - You are on stable RA medication **You may NOT be eligible if...** - You have active joint infection or recent joint surgery - You have certain serious infections (HIV, hepatitis, active tuberculosis) - You are pregnant or breastfeeding - You have significant liver, kidney, or blood disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGF8IL10

Intra-articular treatment


Locations(2)

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, Italy

Azienda Ospedaliera Universitaria Integrata Verona c/o Policlinico GB Rossi (Borgo Roma), Dep. Reumatologia

Verona, VR, Italy

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NCT07245992


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