Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by each country’s regulatory authorities. These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

Yes, the study medication has been used before in a trial of 486 participants for knee OA. In this study, the study medication will be tested as an injection under the skin (in the abdomen or thigh) for the treatment of knee osteoarthritis. Since the study medication has not yet been approved for this indication, it is considered investigational for the purposes of this study.

Yes, in a previous clinical studies and expanded access programs with 486 participants with knee osteoarthritis, it was shown that twice weekly injection of the study medication was effective in reducing knee pain. Those study results supported further research of the study medication for knee osteoarthritis pain.

This study will enroll up to 466 men and women with knee osteoarthritis at select study locations in the USA and Australia.

No, as part of the study participants will be randomly assigned (like rolling a dice) to receive either the investigational medication (50% chance) or a placebo medication (50% chance). The placebo medication looks just like the investigational medication but has no active ingredient. Neither you nor your doctor will know which medication you receive. This is a common technique in clinical studies, as it helps doctors and researchers understand the effects of the investigational medication without bias

No, participants in the study will receive all study-related care and study medication at no cost. Health insurance is not required to participate. You will be compensated for your time and travel to attend required visits at your study doctor’s office

The study lasts about 15-16 months. Following an initial Screening Period of 6-7 weeks to confirm if you are eligible to join the study, you will begin the Treatment Period (about 6 weeks). During the Treatment Period, you will visit your study doctor’s office twice per week for 6 weeks to receive the study injection. Once the Treatment Period has ended, you will enter a Follow-Up Period (about 12 months) to understand how the treatment worked for you. The Follow-Up Period involves 9 total visits to your study doctor’s office, the first 5 about one month apart and the last 4 about two months apart.

As with all clinical studies, your participation is completely voluntary. You may leave the study at any time without any effect on your future medical care

Please contact your local study center, and they will work with you to schedule a convenient time for your initial visit.