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3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT04931667
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Biosplice Therapeutics, Inc.

Brief Summary:
This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Lorecivivint Phase 3

Detailed Description:
At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period. Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 [End of study (EOS)] or Early Termination (ET) for completion of all Patient Reported Outcome (PRO) measurements Western Ontario and McMaster University Arthritis Index (WOMAC), Knee Injury and Ostheoarthritis Outcome Score (KOOS), pain Numeric Rating Scale (NRS), Study Form (SF)-12, Patient Acceptable Symptom State Questionnaire (PASS), Work Productivity and Activity Impairment Questionnaire (WPAI)], functional tests [40-meter walk test and Time Up and Go (TUG) test at a subset of sites], and safety evaluations. On Day 1, the Charlson Comorbidity Index and Widespread Pain Index and Symptom Severity [WPI&SS] assessments will also be completed. A phone visit for safety follow-up will occur 4 weeks after the injection on Day 1. Subjects may also have Unscheduled Injection Visits for additional injections of LOR, glucocorticoid, or hyaluronic acid (HA). Following each injection, subjects will return to the clinic for 3-Month Post-Injection Follow-Up Visits, unless another visit has occurred between the injection and the 3-month post injection date. At these injection visits and 3-Month Post-Injection Follow-Up Visits, subjects will complete PRO measurements and functional tests (at a subset of sites).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : July 1, 2026
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 0.07 mg Lorecivivint
One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.
Drug: Lorecivivint
Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
Other Name: SM04690




Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From Study Day 1 through Subject's last visit, Early Termination (ET) or End of Study (EOS), up to 36 months. ]
    AEs that occur during the study will be recorded. All AEs will be evaluated for severity, seriousness and causal relationship to study medication.


Secondary Outcome Measures :
  1. Change from baseline in pain numeric rating scale (NRS) score for the knee [ Time Frame: 3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months ]
    Change from baseline in pain numeric rating scale (NRS) score for the knee. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.

  2. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function) [ Time Frame: 3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months ]
    Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 4 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 68 (raw) and will be scaled 0 to 100 for reporting.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA
  2. Femorotibial OA by standard American College of Rheumatology (ACR) criteria; knee OA is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis).
  3. Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit
  4. Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, and benzodiazepine, unless any of these drugs are prescribed by a physician to treat a specific condition
  5. Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
  6. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria:

  1. 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 Screening and Day 1
  2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period
  3. Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
  4. Intra-articular (IA) injection into either 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
  5. Any condition that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
  6. Any comorbid condition that could affect study endpoint assessments of the knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
  7. Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931667


Contacts
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Contact: Biosplice Clinical Trials 1-855-222-0515 clinicaltrials@biosplice.com

Locations
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United States, Arizona
Research Site Recruiting
Tucson, Arizona, United States, 85712
United States, Florida
Research Site Recruiting
Winter Park, Florida, United States, 32789
United States, Illinois
Research Site Not yet recruiting
Oak Brook, Illinois, United States, 60523
Sponsors and Collaborators
Biosplice Therapeutics, Inc.
Investigators
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Study Director: Yusuf Yazici, MD Biosplice Therapeutics, Inc.
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Responsible Party: Biosplice Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04931667    
Other Study ID Numbers: SM04690-OA-17
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biosplice Therapeutics, Inc.:
SM04690
Wnt pathway inhibitor
osteoarthritis
Biosplice Therapeutics, Inc.
Lorecivivint
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adavivint
Anti-Inflammatory Agents