Efficacy & Safety of Fasinumab in Low Back Pain & Osteoarthritis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
IRAS ID
236893
Contact name
Michelle Wong
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Eudract number
2017-001943-12
Clinicaltrials.gov Identifier
103245, IND number
Duration of Study in the UK
2 years, 7 months, 11 days
Research summary
This is a research study of the investigational drug, fasinumab, for the treatment of chronic moderate-to-severe low back pain in patients who have osteoarthritis (OA) of the hip or knee. Regeneron Pharmaceuticals Inc. is conducting this study to determine how effective and how safe fasinumab is for the treatment of chronic low back pain (CLBP) for patients that have OA compared to placebo (an inactive substance). Despite the pain medications currently available many patients with CLBP do not obtain adequate pain relief. Patients are eligible for the study if they have OA of hip or knee and chronic low back pain with a history of inadequate pain relief or intolerance to current pain therapy and inadequate pain relief to non-drug therapy.
Fasinumab is a fully human monoclonal antibody (a type of protein) that blocks the act of a substance called nerve growth factor (NGF) that causes pain. Blocking the action of NGF may reduce CLBP.The study will be conducted at sites globally that specialize in treating patients with CLBP and OA. Patients will have a 50% chance to be placed in the fasinumab treatment group and 50% chance to be placed in the fasinumab matching placebo group. The subcutaneous (SC) injections will be given in the upper arm, abdomen or thigh by the study doctor or study staff at the baseline visit, and then every 4 weeks up to Week 12. If the patient completes the full study treatment, they will receive a maximum of 4 injections.
The duration of the study is 64 weeks from baseline to last phone contact. There will be 10 clinic visits and 5 phone contacts. The last office visit will be around 36 weeks, and the last phone contact will be 52 weeks (around week 64) after last planned dose of study drug.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0082
Date of REC Opinion
22 May 2018
REC opinion
Further Information Favourable Opinion