Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
Study NCT ID:
NCT03956550
Status:
TERMINATED
Last Update Posted:
2021-07-01
First Post:
2019-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Regeneron has discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.
The secondary objectives of the study are:
* To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
* To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
* To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
The secondary objectives of the study are:
* To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
* To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
* To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: