Lorecivivint for Osteoarthritis

Recruiting at -1 trial locations

Overseen By Carmen L. McWilliams

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Biosplice Therapeutics, Inc.

Must not be taking: Glucocorticoids, Hyaluronic acid, others

Disqualifiers: Pregnancy, Disability claim, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

276 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of lorecivivint injections in patients with knee osteoarthritis who were part of a previous study. The medication aims to reduce pain and improve knee function. Patients will receive injections periodically and be monitored for their symptoms and any side effects.

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.

What data supports the effectiveness of the drug Lorecivivint for osteoarthritis?

Research shows that Lorecivivint, a drug being tested for knee osteoarthritis, has led to improvements in patient-reported outcomes and radiographic results compared to a placebo. It is considered safe and well-tolerated, with ongoing studies to further evaluate its potential as a disease-modifying drug for osteoarthritis. ^{1 2 3 4 5}

How is the drug Lorecivivint different from other osteoarthritis treatments?

Lorecivivint is unique because it is an intra-articular (injected directly into the joint) drug that targets the Wnt signaling pathway, potentially modifying the disease itself rather than just managing pain, which is the focus of most current osteoarthritis treatments. ^{1 2 3 4 5}

Research Team

Ismail Simsek, MD

Principal Investigator

Biosplice Therapeutics, Inc.

Eligibility Criteria

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

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

Timeline

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

Treatment Details

Interventions

• Lorecivivint
• Placebo

Participant Groups

Group I: Arm 2 Experimental Treatment 2 Interventions

Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter.

Group II: Arm 1 Experimental Treatment 1 Intervention

Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter.

Who Is Running the Clinical Trial?

Biosplice Therapeutics, Inc.

Lead Sponsor

Trials

22

Recruited

5,300+

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of lorecivivint on osteoarthritis: A systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A Phase 2b randomized trial of lorecivivint, a novel intra-articular CLK2/DYRK1A inhibitor and Wnt pathway modulator for knee osteoarthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Individual Participant Symptom Responses to Intra-Articular Lorecivivint in Knee Osteoarthritis: Post Hoc Analysis of a Phase 2B Trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Lorecivivint, an intra-articular potential disease-modifying osteoarthritis drug. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Same-Knee Intra-Articular Injection of Corticosteroid and Lorecivivint Within 7 Days: An Open-Label, Randomized, Parallel-Arm Study. [2023]