Summary:
Protocol TGC12301 is a randomized, double-blinded, placebo-controlled, multi-center phase III study. A total of 510 adults will be enrolled and randomized in a 2:1 manner, with 340 treated subjects and 170 placebo subjects, with radiographically determined stage 2 or 3 primary osteoarthritis of the knee joint. All study subjects will be followed for a period of 24 months, (104 weeks) after injection. During participation in the study, if there is no relief from symptoms, subjects may choose to undergo a surgical procedure including (total knee arthroplasty) 12 months or more after dosing at their own discretion in consultation with the investigator.
Qualified Participants Must:
• Be age 40 and older
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Have Osteoarthritis of the knee
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Have a BMI between 18.5 and 40
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Be able to provide current MRI of target knee
Qualified Participants May Receive:
- Qualified participants will receive randomization treatment for knee pain by injection.
- Follow up and assessment of knee after injection for a period of 24 months.
- Potential Reimbursement if qualified for the study (at discretion of study sponsor. )