Lorecivivint for Osteoarthritis

No longer recruiting at 1 trial location
BC
CL
Overseen ByCarmen L. McWilliams
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

IS

Ismail Simsek, MD

Principal Investigator

Biosplice Therapeutics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

You have completed the Samumed study SM04690-OA-11.
You understand the ICF and are willing to sign it.
Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator Fully understanding study requirements and willingness to comply with study visits and assessments
See 2 more

Exclusion Criteria

Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive a blinded study injection into their target knee, with follow-up injections every 52 weeks

48 weeks
Multiple visits for assessments and injections

Open-label extension

Participants receive open-label injections of 0.07 mg LOR into their target knee every 52 weeks

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lorecivivint
  • Placebo
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
Group II: Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biosplice Therapeutics, Inc.

Lead Sponsor

Trials
22
Recruited
5,300+

Citations

Evaluation of Safety and Efficacy of a Single Lorecivivint ...More patients in the LOR-treated group reported feeling less knee pain and improved function than those in the PBO group; however, because knee ...
NCT03928184 | A Study Utilizing Patient-Reported and ...Impact of structural severity on outcomes in knee osteoarthritis: an analysis of data from phase 2 and phase 3 lorecivivint clinical trials. Rheumatology ...
Lorecivivint Shows Promising Efficacy for Managing Knee ...The results indicated that LOR was well-tolerated, with no significant differences in the number of major adverse events compared with placebo.
OP0326 RADIOGRAPHIC AND PAIN OUTCOMES FROM ...Lorecivivint (LOR), an intra-articular (IA) CLK/DYRK inhibitor thought to modulate Wnt and inflammatory pathways has previously appeared safe, improved patient- ...
Lorecivivint may be the 'first disease-modifying treatment ...“The results of the OA-07 study indicate that lorecivivint appears well-tolerated and may improve pain, function, and structure in knee OA ...
An integrated safety analysis of lorecivivint, a novel, intra ...Conclusions: Based on the data from 3 completed clinical trials, IA LOR for the treatment of knee OA appeared to have a favorable safety profile. These data ...
NCT04520607 | A Long-Term Safety and Efficacy Study of ...It aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects with knee osteoarthritis (OA). The first 48 weeks will be single- ...
OP0188 INTEGRATED SAFETY SUMMARY OF THE ...Safety data were pooled from 3 randomized controlled trials (one Phase 1, two Phase 2) evaluating 4 doses (0.03 mg, 0.07 mg, 0.15 mg, 0.23 mg) of a single IA ...
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