RG6125 / Roche - LARVOL DELTA

RG6125: NME submission in US for RA in 2021 or later (Roche) - Q2 2018 Results: Regulatory submission in EU for RA in 2021 or later

BLA • European regulatory • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy (clinicaltrials.gov) - P2; N=109; Terminated; Sponsor: Hoffmann-La Roche; Completed ➔ Terminated; The trial was prematurely terminated due to a lack of efficacy of the investigational drug.

Trial termination • CRP

RESULTS OF A PHASE 2 STUDY OF RG6125, AN ANTI-CADHERIN-11 MONOCLONAL ANTIBODY, IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO ANTI-TNFALPHA THERAPY (EULAR 2019) - "RG6125 was well tolerated with only mild to moderate AEs. RG6125 did not show a discernible treatment effect in RA patients in combination with anti-TNFα-blockers over placebo."

Clinical • P2 data