MedTrace Logo

A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

NCT03956550 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2021-07-01

Study results available
· View outcomes & findings →

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

Conditions

  • Osteoarthritis of the Knee
  • Pain

Interventions

DRUG

REGN5069

Intravenous (IV) Dose every 4 weeks (Q4W)

DRUG

Matching Placebo

Intravenous (IV) Dose every 4 weeks (QW4)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-21
Primary Completion
2020-05-01
Completion
2020-10-29
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Moldova
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956550 on ClinicalTrials.gov