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Wnt Pathway Inhibitor

Lorecivivint for Osteoarthritis

Phase 3
Waitlist Available
Research Sponsored by Biosplice Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1e (day 1) through visit 3e (week 48)
Awards & highlights

Study Summary

This trial will study the long-term effects of a drug called lorecivivint on people with knee osteoarthritis. The first part of the study will be placebo-controlled (meaning some people will take a fake pill), but after that it will be open-label (meaning everyone will take the real drug).

Eligible Conditions
  • Osteoarthritis of the Knee

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1e (day 1) through visit 3e (week 48)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1e (day 1) through visit 3e (week 48) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Outcome: Change from parent-study baseline medial joint space width (mJSW) in the target knee
Primary Safety Outcome: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary outcome measures
Change from parent-study baseline OA function in the target knee
Change from parent-study baseline OA pain in the target knee

Side effects data

From 2018 Phase 2 trial • 700 Patients • NCT03122860
8%
Arthralgia
3%
Sinusitis
3%
Upper respiratory tract infection
1%
Bronchitis
1%
Nephrolithiasis
1%
Invasive ductal breast carcinoma
1%
Urinary tract infection
1%
Joint stiffness
1%
Viral upper respiratory tract infection
1%
Pain in extremity
1%
Abdominal tenderness
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.23 mg SM04690
0.03 mg SM04690
0.07 mg SM04690
0.15 mg SM04690
Placebo
Sham
Other

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 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 1Experimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Lorecivivint
2019
Completed Phase 3
~1020

Who is running the clinical trial?

Biosplice Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
5,120 Total Patients Enrolled
10 Trials studying Osteoarthritis
3,668 Patients Enrolled for Osteoarthritis
Ismail Simsek, MDStudy DirectorBiosplice Therapeutics, Inc.

Media Library

Lorecivivint (Wnt Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04520607 — Phase 3
Osteoarthritis Research Study Groups: Arm 1, Arm 2
Osteoarthritis Clinical Trial 2023: Lorecivivint Highlights & Side Effects. Trial Name: NCT04520607 — Phase 3
Lorecivivint (Wnt Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520607 — Phase 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04520607 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people of all ages being accepted for this trial, or are there age restrictions?

"According to the inclusionary age parameters set for this particular trial, eligible participants must be between 41 and 81 years old."

Answered by AI

What is the historical context of this research?

"Lorecivivint is only being studied in one active trial across 47 cities and 1 country. The first study for Lorecivivint was run in 2020 by Biosplice Therapeutics, Inc. That initial Phase 3 drug approval stage involved 276 participants and completed successfully. Since then, a total of 18290 trials have been conducted."

Answered by AI

How many research participants are needed for this project?

"This research is no longer enrolling patients. The trial was announced on 8/25/2020 and the last update was on 4/14/2022. For those still searching, there are 724 ongoing trials for osteoarthritis, knee and 1 study for Lorecivivint that are presently recruiting individuals."

Answered by AI

What are the ineligibility requirements for this clinical trial?

"The requirements for patients that wish to enroll in this study are as follows: a diagnosis of osteoarthritis, knee pain, and an age between 41 and 81. This clinical trial has space for 276 individuals in total."

Answered by AI

Does this research project have positions open in more than one city?

"Currently, this study is enrolling patients at 27 clinical sites. The locations of these facilities are listed on the website and include major cities such as New Orleans, Winston-Salem and Winter Haven. Additionally, there are 27 other locations spread out across different cities. If you choose to enroll in this study, try to select a clinic that is nearest to your location to minimize travel requirements."

Answered by AI

What does this clinical trial aim to achieve?

"According to the sponsor of this trial, Biosplice Therapeutics, Inc., the primary outcome will be safety-related. This will be measured by observing any adverse effects or serious adverse events that occur over the course of the study in relation to a parent-study baseline. Additionally, secondary outcomes being assessed include changes in physical function as determined by subscores on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Another metric for change that will be monitored is joint space width as observed via X-ray radiograph."

Answered by AI

What are the possible side effects of Lorecivint?

"There is some evidence for efficacy and multiple data sets indicating safety, so our team has given Lorecivint a score of 3."

Answered by AI

What are some of the other areas in which Lorecivivint has been studied?

"At present, there is 1 ongoing clinical trial evaluating the efficacy of Lorecivivint. This particular study is in Phase 3. In addition, 47 medical facilities across the globe are currently running trials for this medication with many of them being based in Las Vegas, Nevada."

Answered by AI

Are there any open slots left for this research project?

"The specified trial is no longer recruiting patients. According to the information available, it was first posted on 8/25/2020 and last edited on 4/14/2022. There are presently 724 clinical trials actively looking for participants with osteoarthritis and 1 study for Lorecivivint that needs participants."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

Looking for knee cartilage regeneration. i have heard. great results here been achieved.
PatientReceived 2+ prior treatments
Tried NSAID and supplements. Had a hyaluronic steriod injectiopn. I have severe pain in my knees, but I have a physically demanding job and need to keep.
PatientReceived 2+ prior treatments
I have been following the progress of this drug for a while and would love to be involved.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the screening period? How often would I have to come for screening visits?
PatientReceived no prior treatments
how long should i wait for a acceptance response before reapplying, when will this be approved? what is the expected cost?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Research Site: < 24 hours
Average response time
  • < 2 Days
~60 spots leftby Apr 2025