Actively Recruiting
A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
Led by Philogen S.p.A. · Updated on 2026-01-09
42
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of F8IL10 when given by intra-articular injection in patients with Rheumatoid Arthritis (RA). This study aims to find the maximum tolerated dose (MTD) and establish the recommended dose (RD) for F8IL10 treatment in adults aged 18 to 80 years who have RA and experience arthritis flares despite stable treatment with disease-modifying antirheumatic drugs (DMARDs). The study involves two parts: a dose escalation phase where participants receive increasing doses of F8IL10 in their affected joint every 4 weeks for up to three injections, followed by a dose expansion phase treating additional patients at the recommended dose. Dose levels range from 25 to 1000 micrograms. After treatment, participants enter a follow-up period lasting up to 6 months to monitor treatment response, safety, and any changes in disease symptoms. Participants will have regular assessments including safety monitoring for adverse events, injection site reactions, laboratory tests, joint inflammation evaluations, and questionnaires about health and function. Blood samples will be collected to study how the drug moves through the body and immune responses. The main goal is to determine safety and dosing limits, while also observing early signs of effectiveness. The total study duration for each participant, including follow-up, is up to 37 weeks.
CONDITIONS
Brief Title
A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Diagnosis of Rheumatoid Arthritis according to ACR/EULAR criteria with disease duration over 6 months
- Arthritis flare suitable for intra-articular injection in knee, ankle, shoulder, wrist, or elbow despite stable DMARD therapy
- Stable or no NSAIDs and/or oral corticosteroids (≤ 10 mg/day prednisone equivalent) for at least 2 weeks prior
- All acute toxic effects of prior therapy resolved or mild (grade 1)
- Adequate blood counts, liver and kidney function per specified lab values
- Negative tuberculosis test
- Negative tests for HIV, HBV, and HCV with specific criteria for past exposures
- Use of effective contraception for females and males of childbearing potential
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Additional RA flares likely to require local treatment during the study
- Active infections or severe concurrent diseases
- Pregnancy, lactation, or unwillingness to use contraception
- Other inflammatory arthritis or active autoimmune diseases besides RA
- RA therapies outside allowed background treatments within 4 weeks prior to dosing
- Recent intra-articular corticosteroids/DMARDs within 4 weeks or 5 half-lives prior to dosing
- History or active immunodeficiency
- Current or recent malignancy within 2 years except certain skin cancers
- Recent major cardiac events or unstable angina
- Use of warfarin or coumarin derivatives
- Significant cardiac arrhythmias or ECG abnormalities
- Uncontrolled hypertension
- Known arterial aneurysm at high risk
- Severe peripheral vascular disease or diabetic retinopathy
- Major trauma or surgery within 4 weeks before treatment
- Allergy to F8IL10 components
- Recent use of investigational agents
- Recent live vaccine or plan to receive vaccines during study
- Non-RA chronic pain disorders
- Corticosteroid doses over 10 mg/day prednisone equivalent
- Recent substance abuse
- Any condition impairing compliance with the study protocol
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive intra-articular injections of F8IL10 every 4 weeks for up to 3 administrations to assess safety and determine the recommended dose.
3 visits (in-person, every 4 weeks)
Duration - Up to 24 weeks
Participants are monitored for up to 6 months after treatment to assess treatment response, health status, and any post-treatment adverse events.
Monthly visits for up to 6 months
Trial Site Locations
Total: 2 locations
1
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Emilia, Italy, 42123
Not Yet Recruiting
2
Azienda Ospedaliera Universitaria Integrata Verona c/o Policlinico GB Rossi (Borgo Roma), Dep. Reumatologia
Verona, VR, Italy, 37134
Actively Recruiting
Research Team
L
Louis Plüss
F
Federica Bastioli, Pharmaceutical Chemist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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