Phase 3 Study to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Last updated: N/A
Sponsor: N/A
Overall Status: Active - Recruiting







Clinical Study ID

  • Ages 40-80
  • All Genders

Study Summary

This is a 56-week, placebo controlled study to evaluate the efficacy and safety of the SM04690 injectable suspension 0.07 mg dose in the treatment of knee osteoarthritis (OA). Both patient-reported and radiographic measures will be used to assess efficacy.

Subjects will participate in a 10- to 22-day screening period followed by a single injection and a 6-month evaluation period. Clinic visits will be scheduled at screening visit 1, screening visit 2, Day 1, and weeks 4, 12 and 24. Radiographic images of the knee will be performed at screening visit 1 and week 24.

Subjects will be required to complete a daily electronic diary throughout the study.

Eligibility Criteria


  • Subjects must have a clinical and radiographic diagnosis of femorotibial OA in the target knee at screening;
  • OA of the knee is not to be secondary to any rheumatologic conditions.
  • Subjects must be ambulatory, single assistive devices such as canes are allowed if needed less than 50% of the time.
  • Subjects requiring a walker are excluded.
  • Primary source of pain throughout the body must be due to OA in the target knee.
  • Subjects must have a BMI under 35
  • Subjects excluded if they have had a single or bilateral, partial or complete knee or hip replacement.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

For more information, please contact the study coordinator, Deb, at

Connect with a study center

  • Alpine Clinical Research Center

    Boulder, Colorado 80301
    United States

    Active - Recruiting

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