Actively Recruiting
A 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
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Diagnosed with Rheumatoid Arthritis according to 2010 criteria, with disease lasting more than 6 months
- Experiencing arthritis flare(s) suitable for injection in knee, ankle, shoulder, wrist, or elbow despite stable DMARD therapy for at least 3 months
- No or stable NSAIDs and/or oral corticosteroids (prednisone ≤10 mg/day) for at least 2 weeks before screening
- All prior therapy toxic effects resolved or mild per CTCAE v5.0
- Adequate blood counts and liver and kidney function within specified laboratory limits
- Negative tuberculosis test
- Negative tests for HIV, HBV, and HCV as specified
- Women of childbearing potential must have negative pregnancy test and agree to effective birth control before and up to 6 months after treatment
- Men must agree to use effective contraception from screening to 6 months after last drug dose
- Signed informed consent
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Additional RA flares or symptoms likely to require local treatment during the study
- Active infections or severe diseases that pose risk or interfere with the study
- Pregnancy, breastfeeding, or unwillingness to use adequate contraception
- Other inflammatory arthritis or active autoimmune diseases besides RA
- Use of RA therapies outside allowed stable background therapy within 4 weeks before first dose
- Intra-articular corticosteroids or DMARDs within 4 weeks or 5 half-lives before first dose, whichever is longer
- History or active immunodeficiency
- Current or recent malignancy except certain skin cancers with disease-free period less than 2 years
- Recent serious cardiac events within the last year
- Use of warfarin or coumarin derivatives
- Significant cardiac arrhythmias or abnormal ECG including QT/QTc prolongation
- Uncontrolled hypertension
- Known arterial aneurysm at high rupture risk
- Severe diabetic retinopathy
- Major surgery or trauma within 4 weeks before treatment
- Allergy or intolerance to F8IL10 or its components
- Use of investigational agents within 4 weeks or 5 half-lives before first dose
- Recent or planned live/attenuated vaccinations
- Chronic pain disorders unrelated to RA
- Corticosteroid doses over 10 mg/day (prednisone equivalent)
- Recent alcohol, drug, or substance abuse within 6 months
- Any condition impairing compliance with the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
F
Federica Bastioli, Pharmaceutical Chemist
CONTACT
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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