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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%
Upper respiratory tract infection
2%
Viral upper respiratory tract infection
1%
Supraventricular tachycardia
1%
Sinusitis
1%
Blood lactate dehydrogenase increased
1%
Nephrolithiasis
1%
Urinary tract infection
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a potential study participant is over 20, will they be able to enroll?
"The age range for this study is from 40 to 80 years old."
Answered by AI
What is the most severe reaction that patients have had to Lorecivint?
"There is evidence from past clinical trials to support the safety of Lorecivint, so it received a score of 3."
Answered by AI
Are we still able to enroll patients in this research project?
"The latest information from clinicaltrials.gov suggests that this trial is not currently recruiting patients, though it was active on November 14th, 2020 and updated as recently as November 15th, 2020. There are 724 other trials that you may be eligible for."
Answered by AI
Which type of patient does this research project seek?
"This clinical trial is looking for 550 people with knee aged 40 and 80. Most notable, applicants should meet the following criteria: Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA, 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"
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Research Site
Eastern Research, Inc.
West Houston Clinical Research Service
Other
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
Saw it on Facebook. I have a lot of pain. Need help with knee pain. To get relief from my knee pain.
PatientReceived 2+ prior treatments
Para tratar de levantar la enfermedad.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How much does it pay? How long does this research take? What is the duration of the study ?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Research Site: < 48 hours
Typically responds via
Phone Call
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