FNS-007 / Hebei Fitness Biotechnology - LARVOL DELTA

A multicenter, randomized, double-blind, double-dummy, placebo-controlled and active-controlled clinical study to evaluate the efficacy and safety of FNS007 for injection in patients with moderate to severe rheumatoid arthritis. (ChiCTR) - P2 | N=120 | Recruiting | Sponsor: Peking University People's Hospital; Hebei Fitness Biotechnology Co., Ltd.

New P2 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Safety and Efficacy of FNS007, a Non-T Cell Receptor Contacting Peptide, for Patients with Active Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial (ACR Convergence 2024) - "Here, we conducted a first-in-human phase 1b dose escalation trial of FNS007, a non-T cell receptor (TCR) contacting peptide derived from Collagen II, to determine its safety and efficacy in RA patients. This multicenter, randomized, double-blind, placebo-controlled study of FNS007 enrolled patients 18-70 years of age with active RA who had an inadequate response to csDMARDs (methotrexate or leflunomide). This study demonstrated that FNS007 was tolerated and effective in a dose-dependent manner. It indicated that FNS007 might eliminate Teff cells and increase TGF-β to induce immune tolerance. The results support a future phase 2 clinical trial."

Clinical • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TGFB1