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Wnt Pathway Inhibitor

A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)

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
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at the Screening Visit (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
Timeline
Screening 2 days
Treatment Varies
Follow Up 4 days
Awards & highlights
Pivotal Trial

Summary

This trial tests a knee injection called lorecivivint for people with severe knee osteoarthritis. The injection aims to reduce pain and improve movement by targeting the painful knee directly. Lorecivivint (LOR) is being tested for its potential to treat osteoarthritis.

Eligible Conditions
  • Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing knee pain for at least 26 weeks before the screening visit, which is consistent with osteoarthritis.
Select...
You are between the ages of 40 and 80 and generally in good health, except for knee osteoarthritis.

Timeline

Screening ~ 2 days
Treatment ~ Varies
Follow Up ~4 days
This trial's timeline: 2 days for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee
Secondary study objectives
Disease
Change from baseline OA function as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) at Week 12

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LorecivivintExperimental Treatment1 Intervention
Healthcare professional-administered intra-articular injection; performed on Day 1.
Group II: VehiclePlacebo Group1 Intervention
Healthcare professional-administered intra-articular injection; performed on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorecivivint
2019
Completed Phase 3
~1510

Find a Location

Who is running the clinical trial?

NBCD A/SIndustry Sponsor
10 Previous Clinical Trials
1,835 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,343 Patients Enrolled for Osteoarthritis
Biosplice Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
4,846 Total Patients Enrolled
10 Trials studying Osteoarthritis
3,394 Patients Enrolled for Osteoarthritis
Yusuf Yazici, MDStudy DirectorBiosplice Therapeutics, Inc.
2 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Osteoarthritis
73 Patients Enrolled for Osteoarthritis
Yusuf Yazici, M.D.Study DirectorBiosplice Therapeutics, Inc.
15 Previous Clinical Trials
4,311 Total Patients Enrolled
7 Trials studying Osteoarthritis
2,984 Patients Enrolled for Osteoarthritis

Media Library

Lorecivivint (Wnt Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05603754 — Phase 3
Osteoarthritis Research Study Groups: Lorecivivint, Vehicle
Osteoarthritis Clinical Trial 2023: Lorecivivint Highlights & Side Effects. Trial Name: NCT05603754 — Phase 3
Lorecivivint (Wnt Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603754 — Phase 3
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05603754 — Phase 3
~161 spots leftby Dec 2025