Clinical trial • Phase I • Immunology
F8IL10 for Rheumatoid arthritis
Phase I trial of F8IL10 for Rheumatoid arthritis. 42 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase I
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 20-12-2024
- First CTIS Authorization Date
- 22-04-2025
Trial design
Phase I trial across 2 sites in Italy.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 42
Eligibility
Recruits 42 adults.
Inclusion criteria
- {"criterion_text":"- Patients with Rheumatoid Arthritis (RA) who, despite treatment with stable doses (for at least 3 months) of disease-modifying antirheumatic drugs (DMARDs, conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for intra-articular (IA) injection in a knee, shoulder, ankle, wrist or elbow."}
Recruitment
- Planned Sample Size
- 42
- Recruitment Window Months
- 53
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 42
Italy
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 257
- Number Of Sites
- 2
- Number Of Participants
- 42
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Elena Fracassi
- Principal Investigator Email
- elena.fracassi@univr.it
- Contact Person Name
- Elena Fracassi
- Contact Person Email
- elena.fracassi@univr.it
- Site Name
- AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
- Department Name
- Rheumatology
- Principal Investigator Name
- Filippo Crescentini
- Principal Investigator Email
- filippo.crescentini@ausl.re.it
- Contact Person Name
- Filippo Crescentini
- Contact Person Email
- filippo.crescentini@ausl.re.it
Sponsor
Primary sponsor
- Full Name
- Philogen S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- F8IL10 intra-articular
- Active Substance
- F8IL10
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intra-articular
- Route
- Intra-articular
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