RHH646 for Knee Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new treatment, RHH646, can regenerate knee cartilage and is safe for individuals with knee osteoarthritis. Participants will receive either RHH646 or a placebo to compare results. The trial suits those who have experienced knee pain from osteoarthritis at least three days a week over the past three months and find relief with painkillers like acetaminophen or ibuprofen. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that knee pain should be relieved by analgesic therapy like acetaminophen or non-steroidal anti-inflammatory drugs, so these may be allowed.
Is there any evidence suggesting that RHH646 is likely to be safe for humans?
Research has shown that RHH646, the treatment under study for knee osteoarthritis, is safe and well-tolerated. In one study, researchers closely monitored participants who received RHH646 for any side effects. No major safety issues emerged, and participants generally tolerated the treatment well, with no reports of serious side effects. These findings suggest that RHH646 could be safe for people, but further research is necessary to confirm this.12345
Why do researchers think this study treatment might be promising for knee osteoarthritis?
Unlike the standard treatments for knee osteoarthritis, which often include pain relievers like NSAIDs or corticosteroid injections, RHH646 offers a novel approach. Researchers are excited about RHH646 because it targets specific inflammatory pathways in the knee joint, potentially reducing inflammation and pain more effectively. This innovative mechanism of action could lead to better symptom management and improved quality of life for patients, making it a promising alternative to current options.
What evidence suggests that RHH646 might be an effective treatment for knee osteoarthritis?
Research shows that RHH646, which participants in this trial may receive, is under study for its potential to regrow knee cartilage and improve osteoarthritis symptoms. Early studies have examined its effectiveness in encouraging cartilage growth, crucial for managing knee osteoarthritis. Participants take this treatment as a pill once a day for a year, ensuring ease of use. Although detailed results on its efficacy are not yet available, ongoing research continues to explore its potential benefits. Initial findings suggest that RHH646 might reduce joint pain and stiffness by promoting healthier cartilage.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 35-75 with knee osteoarthritis, meeting specific criteria like weight over 50 kg, BMI ≤35 kg/m2, and certain levels of joint space width. They must have regular knee pain relieved by analgesics. Excluded are pregnant women not using contraception, those with recent or planned surgeries on the target knee, severe malalignment in the knee, other major knee pathologies or conditions affecting MRI procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RHH646 or placebo for up to 52 weeks to evaluate cartilage-regenerating capacity and assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RHH646
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD