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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Rheumatoid Arthritis
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"

All Listed Sponsors
lead

Philogen S.p.A.

INDUSTRY

NCT05622175 - Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment | Biotech Hunter | Biotech Hunter