R475-OA-1688, Efficacy and Safety of Fasinumab
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID-Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip.
IRAS ID
238597
Contact name
Rex Sarmiento
Contact email
Sponsor organisation
Regeneron Pharmceuticals Inc
Eudract number
2017-001702-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
This study designed to evaluate the efficacy and safety of fasinumab in patients with OA of the knee or hip who have a history of inadequate pain relief with acetaminophen/paracetamol and a history of intolerance to or inadequate pain relief with opioids.
There is an unmet need for alternative treatment options to the standard of care NSAIDs and opioids that have a more effective analgesic effect, particularly since a significant number of patients are intolerant to, or do not get adequate pain relief from, the currently available treatment options. Inadequate pain relief has a profound impact on the quality of life for millions of people worldwide.
The main aim of this study is to see how well the study drug Fasinumab compares to placebo when given to patients who have OA of the knee of hip. Toward this aim patients will be split into 3 separate active dosing arms and one placebo arm in the follow doses:
• 1mg subcutaneous (SC) injection every 4 weeks
• 3mg SC injection every 4 weeks
• 6mg SC injection every 8 weeks, with a placebo injection every 4 weeks
• Placebo SC injection every 4 weeks
There are also secondary aims to see how well Fasinumab compares to the two main standard of care NSAIDs. There are therefore 2 additional dosing arms of:
• Diclogenac 75mg by mouth twice daily (placebo injections)
• Cececoxib 200mg by mouth once daily (placebo injections)
All patients will receive injections at 4 weekly intervals and will take capsules twice daily with placebo injections and capsules used to maintain the blind.
The study is double blind, therefore neither the patient nor the study doctor will know who receives fasinumab, diclofenac, celecoxib, or placebo. The treatment period for this study is 24 weeks and there will be a follow up period of 20 weeks.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
18/EM/0038
Date of REC Opinion
15 Feb 2018
REC opinion
Unfavourable Opinion