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

Updated on 23 November 2020


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. 


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

Condition Osteoarthritis
Clinical Study IdentifierTX223533
Last Modified on23 November 2020


Yes No Not Sure

Inclusion 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note