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Wnt Pathway Inhibitor
Lorecivivint for Osteoarthritis
Phase 3
Recruiting
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
Study Summary
This trial will test a new injection to treat knee osteoarthritis pain. It will measure safety & effectiveness of the injection.
Eligible Conditions
- Osteoarthritis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 days2 visits
Treatment ~ Varies
Follow Up ~ 4 days4 visits
Screening ~ 2 days
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Knee
Secondary outcome measures
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 • NCT031228606%
Arthralgia
3%
Bronchitis
2%
Viral upper respiratory tract infection
2%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Sinusitis
1%
Blood lactate dehydrogenase increased
1%
Supraventricular tachycardia
1%
Nephrolithiasis
1%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.03 mg SM04690
0.15 mg SM04690
Placebo
0.07 mg SM04690
0.23 mg SM04690
Sham
Other
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
~1020
Find a Location
Who is running the clinical trial?
NBCD A/SIndustry Sponsor
8 Previous Clinical Trials
1,350 Total Patients Enrolled
6 Trials studying Osteoarthritis
803 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have participated in another research study involving new medication or experimental treatments within the past 26 weeks, nor can you plan to participate in a study like that during this one.You are between the ages of 40 and 80 and generally in good health, except for knee osteoarthritis.You have already been treated with lorecivivint (SM04690) before.Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by independent central readers.You have a body mass index (BMI) of 35 kg/m2 or less.You have experienced knee pain that is consistent with osteoarthritis for at least 6 months before the screening visit.You cannot take certain pain relievers (such as Tylenol or Advil) during a certain period before the start of the study, except for low doses of aspirin to prevent blood clots.You have been experiencing knee pain for at least 26 weeks before the screening visit, which is consistent with osteoarthritis.You had a knee replacement surgery.You had cancer that was treated in the past 5 years. However, if you had in situ cervical cancer or basal or squamous cell skin cancer that was treated, you may still be eligible.You are between 40 and 80 years old and in good health overall, except for your knee osteoarthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Lorecivivint
- Group 2: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05603754 — Phase 3
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