Lorecivivint for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called lorecivivint to determine its safety and effectiveness for people with knee osteoarthritis, a condition that causes joint pain and stiffness. It begins with a year-long comparison where some participants receive the actual treatment and others receive a placebo (a treatment with no active drug). In the following years, all participants receive the treatment. Individuals who completed a previous related study and have knee osteoarthritis can consider joining. This trial is crucial for those seeking new long-term relief options for knee pain. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for knee osteoarthritis.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that certain treatments like injections into the knee are not allowed. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lorecivivint is generally safe and well-tolerated for people with knee osteoarthritis. Studies have found that injecting the treatment directly into the knee is safe for most individuals, with few experiencing serious side effects. Data from three completed clinical trials support these findings.
In these studies, patients who received different doses of lorecivivint mostly reported only mild to moderate side effects, if any. This suggests that most people can handle the treatment well.
Overall, lorecivivint appears to be a promising option for those with knee osteoarthritis, with good safety results from previous research.12345Why do researchers think this study treatment might be promising for osteoarthritis?
Unlike the usual treatments for osteoarthritis, like NSAIDs or corticosteroid injections, Lorecivivint offers a unique approach. It targets the Wnt signaling pathway, which plays a key role in cartilage health, potentially slowing down cartilage degradation rather than just relieving symptoms. This new mechanism of action is what excites researchers, as it might lead to not only symptom relief but also long-term joint health improvement. Additionally, Lorecivivint is administered directly into the knee joint, which could offer more targeted treatment with fewer systemic side effects compared to oral medications.
What evidence suggests that lorecivivint might be an effective treatment for osteoarthritis?
Research has shown that lorecivivint may help treat knee osteoarthritis. In this trial, participants in Arm 1 will receive lorecivivint. Studies have found that patients who took lorecivivint reported less knee pain and better movement compared to those who took a placebo. This treatment affects certain processes in the body related to inflammation and joint health. Lorecivivint has been well-tolerated, with side effects similar to those in the placebo group. Some studies suggest it might even improve the knee joint's structure, making it a possible treatment that could change the course of the disease. Overall, current evidence supports its potential effectiveness in managing knee osteoarthritis symptoms.15678
Who Is on the Research Team?
Ismail Simsek, MD
Principal Investigator
Biosplice Therapeutics, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a blinded study injection into their target knee, with follow-up injections every 52 weeks
Open-label extension
Participants receive open-label injections of 0.07 mg LOR into their target knee every 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lorecivivint
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biosplice Therapeutics, Inc.
Lead Sponsor