Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03956550
Status:
TERMINATED
Last Update Posted:
2021-07-01
First Post:
2019-05-16
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:
Regeneron Pharmaceuticals
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:
None
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?:
None