REGN5069 in Patients with Osteoarthritis
Research type
Research Study
Full title
A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients with Pain due to Osteoarthritis of the Knee
IRAS ID
265482
Contact name
Fraser Birrell
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc
Eudract number
2018-004730-15
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 9 days
Research summary
Research Summary
REGN5069 is investigational, which means it has not been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK or the European Medicines Agency (EMA) for any health authority for marketing for any condition. REGN5069 is being studied for treatment of pain due to OA (Osteoarthritis) which is a joint disease associated with breakdown of joint cartilage and changes in bone.REGN5069 is an antibody that binds to a substance in the body called GFR3 (Glial cell-line-derived neurotrophic factor receptor alpha-3). Also known as the artemin receptor, is a protein that in humans is encoded by the GFRA3 gene. Antibodies are proteins, naturally found in your body. GFR3 can be found in the nervous system and is involved in the sensation of pain. By binding of REGN5069 to GFR3, REGN5069 should decrease the sensation of pain.
This is a phase 2, randomised, double-blind, placebo-controlled study for adults with pain due to osteoarthritis of the knee. The main purpose of this study is to determine the effect of REGN5069 compared to placebo (an inactive substance) on knee pain caused by OA(osteoarthritis) which is a joint disease caused by breakdown of joint cartilage and bone. This study also aims to understand how safe and tolerable REGN5069 is in participants with knee OA (osteoarthritis) treatment.
The study will include up to 240 participants in around 25 centres worldwide.
Participation in the study may last up to 40 weeks (a 4 week screening period, 12 week treatment period and 24 week follow up period).
REGEN 5069 will be administered intravenously (IV, administration directly into a vein) approximately every 4 weeks (3 times during the study). Other study procedures include physical examinations, blood and urine samples, vital signs, ECG, MRI scans and completing of patient questionaires.
Summary of Results
Lay summary was not planned for this study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0224
Date of REC Opinion
8 Aug 2019
REC opinion
Further Information Favourable Opinion