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Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis


Title A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Therapeutic Area Osteoarthritis
Principal Investigator Timothy E. McAlindon, MD, MPH
Min Age 40 Years
Gender All
Contact Vivian Deng
617 636-5727
More Information https://clinicaltrials.gov/ct2/show/NCT03122860

Overview

Samumed is evaluating a new drug called SM04690 to learn more about the safety and effectiveness of a one-time knee injection for patients with moderate to severe knee osteoarthritis. SM04690 is an investigational drug that has not been approved by the FDA. The study drug aims to target the Wnt pathway in order to reduce cartilage loss among patients who have knee osteoarthritis. There are a total of 6 treatment groups in the study; 4 will receive varying doses of the study medication and 2 will receive a placebo.

Study Details

Inclusion Criteria

  • Subject must have a BMI < 35
  • Subject must have Knee Osteoarthritis
  • Subject must be willing to complete nightly questionnaire on knee pain and stiffness

Exclusion Criteria

  • Subject who requires regular use of assistive devices such as a walker or cane
  • Subject who are breastfeeding or pregnant
  • Subject with a knee replacement or a recent surgery

Study Requirements

Samumed is evaluating a new drug called SM04690 to learn more about the safety and effectiveness of a one-time knee injection for patients with moderate to severe knee osteoarthritis. SM04690 is an investigational drug that has not been approved by the FDA. The study drug aims to target the Wnt pathway in order to reduce cartilage loss among patients who have knee osteoarthritis. There are a total of 6 treatment groups in the study; 4 will receive varying doses of the study medication and 2 will receive a placebo.