Status:
COMPLETED
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
Lead Sponsor:
Biosplice Therapeutics, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of moderately to severe...
Eligibility Criteria
Inclusion
- Key
- 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 to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
- 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
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening Visit
- Primary source of pain throughout the body is due to OA in the target knee
- Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit
- Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and tricyclic antidepressants, unless any of these drugs are allowed per protocol and prescribed by a physician to treat a specific condition
- Key
Exclusion
- Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at the Screening Visit or Day 1
- Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \> 10°, valgus \> 10°) by radiograph within 24 weeks of the Screening Visit as assessed by independent central readers
- Partial or complete joint replacement in either knee
- Currently requires use of a lower extremity prosthesis, and/or a structural knee brace (i.e., a knee brace that contains hardware)
- Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
- Intra-articular (IA) injection into the target knee with a therapeutic aim including, but not limited to hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1; or IA glucocorticoids within 12 weeks prior to Day 1 allowed
- Previous treatment with lorecivivint (SM04690)
- Subjects who have previously failed screening on this protocol and fail to meet re-screening criteria
- Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 26 weeks prior to the Screening Visit, or planned participation in any such trial
- Subjects requiring the use of opioids \> 1x per week within 12 weeks prior to Day 1
- History of malignancy within the last 5 years; not including subjects with prior history of adequately treated in situ cervical cancer or basal or squamous cell skin cancer
- Clinically significant abnormal screening hematology values, blood chemistry values, or urinalysis values as determined by the Investigator
- Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at Day 1
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2021
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT04385303
Start Date
May 26 2020
End Date
September 8 2021
Last Update
March 3 2022
Active Locations (76)
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1
Research Site
Birmingham, Alabama, United States, 35205
2
Research Site
Birmingham, Alabama, United States, 35215
3
Research Site
Mobile, Alabama, United States, 36608
4
Research Site
Phoenix, Arizona, United States, 85018