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

NCT05622175 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622175 on ClinicalTrials.gov