CRHH646A12201 Knee OA safety and efficacy study
Research type
Research Study
Full title
A randomized, placebo controlled, investigator and participant-blinded study investigating safety, tolerability, and efficacy of RHH646 in participants with knee osteoarthritis.
IRAS ID
1007469
Contact name
Angela Muehlenbroich
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2022-502821-16
Research summary
The purpose of the trial is to learn more about how the body reacts to the trial drug RHH646 and to find out if RHH646 can have possible benefits for people with knee osteoarthritis (OA). Having knee OA means that the protective layer of rubber-like tissue called “cartilage” between the large bones in the knee has been damaged. Cartilage does not heal as well as bone or skin when it is damaged. People with knee OA often feel pain and have swelling in the knee. As the damage to the knee cartilage gets worse, the knee joint will not function properly.
This trial is designed to find out if RHH646 can repair the cartilage in the knee. This trial is also designed to learn more about the safety of RHH646.
This trial is blinded. This means that participants and the study doctors will not know if the participant is taking RHH646 (the active drug) or placebo (looks like the trial drug but has no active ingredients in it). The trial lasts for about 14 months and includes up to 78 participants in several countries around the world. Participants will be randomly assigned to receive either RHH646 or placebo. Half of the trial participants will receive RHH646 and half of the trial participants will receive placebo. RHH646 and placebo are both capsules taken by mouth once daily for 12 months.
This trial is for men and women with knee OA who are 35 to 75 years old and have knee pain several days each week that requires treatment with pain medication. Participants should not have had surgery on the knee that has OA or other diseases affecting the knee.
People who participate in this trial may repair some of the damaged cartilage in their knee. The study drug may or may not lessen the pain associated with knee OA. It is also possible that participants in the trial may not directly benefit from the study treatment, but doctors and scientists may learn new information about the disease and/or RHH646 that could help treat other people with knee OA in the future.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
23/SC/0168
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion