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A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520607
Recruitment Status : Active, not recruiting
First Posted : August 20, 2020
Last Update Posted : June 1, 2023
Sponsor:
Information provided by (Responsible Party):
Biosplice Therapeutics, Inc.

Study Description
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Brief Summary:
This study is designed as a long-term extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of long-term use of lorecivivint (LOR) in subjects with knee osteoarthritis (OA). The first 48 weeks will be single-blind and placebo-controlled while the remainder of the study will be open-label and uncontrolled. Subjects must enroll no later than 6 weeks following completion of the parent-study.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Placebo Drug: Lorecivivint Phase 3

Detailed Description:
At the first visit (Day 1), all subjects will complete Patient Acceptable Symptom State (PASS) and pain Numeric Rating Scale (NRS) assessments and then receive a blinded study injection into their target knee (the same target knee injected in the parent study), with subjects receiving the same treatment (either 0.07 mg LOR or placebo) as they received in the parent study. Subjects will have clinic visits for pain and function assessments, collection of adverse events, and knee radiographs. At Week 48, all subjects, regardless of previous treatment, will receive an injection of 0.07 mg LOR into their target knee. Subjects will receive injections of 0.07 mg LOR into their target knee every 52 weeks thereafter until end of study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Note: The first 48 weeks will be single-blind and placebo-controlled while the remainder of the study will be open-label and uncontrolled.
Primary Purpose: Treatment
Official Title: A Long-Term Extension Study Evaluating the Safety and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Subjects assigned to this arm will receive one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study); performed on Day 1, at Week 48 and every 52 weeks thereafter.
 Drug: Lorecivivint
Healthcare professional-administered intra-articular injections of lorecivivint.
Other Name: SM04690
Experimental: Arm 2
Subjects assigned to this arm will receive one intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study) into their target knee (the same target knee injected in the parent study) on Day 1, followed by one intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle at Week 48 and every 52 weeks thereafter.
 Drug: Placebo
Healthcare professional-administered intra-articular injection of vehicle.
Other Name: Vehicle

Drug: Lorecivivint
Healthcare professional-administered intra-articular injections of lorecivivint.
Other Name: SM04690


Outcome Measures
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Primary Outcome Measures :
  1. Primary Safety Outcome: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Visit 1E (Day 1) through Visit 3E (Week 48) ]
    AEs that occur during the study will be recorded, and ongoing AEs at the end of the parent-study will continue to be monitored. All AEs will be evaluated for severity, seriousness and causal relationship to study medication.

  2. Primary Efficacy Outcome: Change from parent-study baseline medial joint space width (mJSW) in the target knee [ Time Frame: Parent-study baseline; Visit 3E (Week 48) ]
    Change from parent-study baseline in mJSW as documented by radiograph (X-ray) of the target knee


Secondary Outcome Measures :
  1. Change from parent-study baseline OA pain in the target knee [ Time Frame: Parent-study baseline; Visit 2E (Week 24) ]
    Change from parent-study baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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 parent-study baseline OA function in the target knee [ Time Frame: Parent-study baseline; Visit 2E (Week 24) ]
    Change from parent-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 170.

  3. Change from parent-study baseline OA pain in the target knee [ Time Frame: Parent-study baseline; Visit 3E (Week 48) ]
    Change from parent-study baseline OA pain in the target knee as assessed by the weekly averages of daily pain Numeric Rating Scale (NRS). 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.

  4. Change from parent-study baseline OA function in the target knee [ Time Frame: Parent-study baseline; Visit 3E (Week 48) ]
    Change from parent-study baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 170.


Eligibility Criteria
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Ages Eligible for Study:   41 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Completion of the Samumed study SM04690-OA-11
  2. Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
  3. Fully understanding study requirements and willingness to comply with study visits and assessments
  4. Understanding and signing of the informed consent form (ICF) prior to any study-related procedures

Exclusion Criteria:

  1. 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
  2. Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
  3. Any known reason identified by the Investigator or Sponsor that the subject may not be compliant with study visits or may no longer be an appropriate candidate for the study (e.g. planned major surgery, knee replacement during the parent study, planning to move away from the research site, or initiation of a prohibited concomitant medication including, but not limited to, IA injection of glucocorticoids, hyaluronic acid derivatives, platelet-rich plasma, stem cell therapies, or other agents with therapeutic intent into the target knee)
  4. Participation in a clinical research trial (other than the prior SM04690-OA-11 study) that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 12 weeks before any study injection, or planned participation in any such trial
  5. Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
  6. 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 Visit 1E (Day 1)
  7. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control (as outlined in the protocol) during the study period
Contacts and Locations
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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): NCT04520607


Locations
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United States, Arizona
Research Site
Tucson, Arizona, United States, 85712
United States, California
Research Site
Anaheim, California, United States, 92805
Research Site
Pomona, California, United States, 91767
Research Site
San Diego, California, United States, 92103
Research Site
Thousand Oaks, California, United States, 91360
United States, Colorado
Research Site
Denver, Colorado, United States, 80209
United States, Florida
Research Site
Hialeah, Florida, United States, 33016
Research Site
Miami Lakes, Florida, United States, 33014
Research Site
Miami, Florida, United States, 33173
Research Site
Port Orange, Florida, United States, 32127
Research Site
West Palm Beach, Florida, United States, 33409
Research Site
Winter Haven, Florida, United States, 33880
Research Site
Winter Park, Florida, United States, 32789
United States, Georgia
Research Site
Newnan, Georgia, United States, 30265
Research Site
Woodstock, Georgia, United States, 30189
United States, Illinois
Research Site
Gurnee, Illinois, United States, 60031
Research Site
Oak Brook, Illinois, United States, 60523
United States, Indiana
Research Site
Valparaiso, Indiana, United States, 46383
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70124
United States, Michigan
Research Site
Bay City, Michigan, United States, 48706
Research Site
Troy, Michigan, United States, 48085
United States, Missouri
Research Site
Hazelwood, Missouri, United States, 63042
Research Site
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68114
United States, New York
Research Site
Hartsdale, New York, United States, 10530
Research Site
New York, New York, United States, 10016
Research Site
Rochester, New York, United States, 14609
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28209
Research Site
Salisbury, North Carolina, United States, 28144
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
Research Site
Columbus, Ohio, United States, 43235
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, South Carolina
Research Site
Fort Mill, South Carolina, United States, 29707
Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Research Site
Carrollton, Texas, United States, 75007
Research Site
Plano, Texas, United States, 75075
Research Site
San Antonio, Texas, United States, 78229
United States, Utah
Research Site
Draper, Utah, United States, 84020
Research Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Research Site
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Biosplice Therapeutics, Inc.
Investigators
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Study Director: Ismail Simsek, MD Biosplice Therapeutics, Inc.
More Information
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Responsible Party: Biosplice Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04520607    
Other Study ID Numbers: SM04690-OA-07
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: June 1, 2023
Last Verified: May 2023
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.
Samumed
lorecivivint
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Lorecivivint
Anti-Inflammatory Agents