Extension Study Evaluating the Safety and Efficacy of a Second Year of Use of Lorecivivint in Subjects With Osteoarthritis of the Knee
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| ClinicalTrials.gov Identifier: NCT04520607 |
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Recruitment Status :
Recruiting
First Posted : August 20, 2020
Last Update Posted : January 20, 2021
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Sponsor:
Samumed LLC
Information provided by (Responsible Party):
Samumed LLC
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Brief Summary:
This study is designed as a 1-year extension to the Phase 3 parent-study SM04690-OA-11. It aims to evaluate the safety and efficacy of a second year of use of lorecivivint in subjects with knee osteoarthritis (OA). Subjects must enroll no later than 6 weeks following completion of the parent-study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis, Knee | Drug: Lorecivivint Drug: Placebo | Phase 3 |
At the first visit (Visit 1E; Day 1) in this study, 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 lorecivivint or placebo) as they received in the parent-study. Subjects will have clinic visits at Visit 2E (Week 24) and Visit 3E (End of Study; Week 48) for subsequent pain and function assessments and for collection of adverse events. Subjects will also undergo knee radiographs at Visit 2E and Visit 3E.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A 48-Week, Placebo-Controlled, Single Blind 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 2022 |
| Estimated Study Completion Date : | September 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
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Experimental: 0.07 mg lorecivivint
One intra-articular injection of 0.07 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study)
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Drug: Lorecivivint
Healthcare professional-administered intra-articular injection (in the same target knee as in the parent-study); performed on Day 1
Other Name: SM04690 |
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Placebo Comparator: Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study)
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Drug: Placebo
Healthcare professional-administered intra-articular injection (in the same target knee as in the parent-study); performed on Day 1
Other Name: Vehicle |
Primary Outcome Measures :
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Visit 1E (Day 1) through Visit 3E (End of Study; 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.
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- Change from parent-study baseline medial joint space width (mJSW) in the target knee [ Time Frame: Parent-study baseline; Visit 3E (End of Study; Week 48) ]Change from parent-study baseline in mJSW as documented by radiograph (X-ray) of the target knee
- Percentage of subjects who consider themselves to be in a Patient Acceptable Symptom State (PASS) [ Time Frame: Visit 1E (Day 1) ]Subjects will be asked the following, using a paper questionnaire: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Subjects are able to choose the answers of "Yes" or "No."
- Percentage of subjects who consider themselves to be in a Patient Acceptable Symptom State (PASS) [ Time Frame: Visit 3E (End of Study; Week 48) ]Subjects will be asked the following, using a paper questionnaire: "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Subjects are able to choose the answers of "Yes" or "No."
- Change from parent-study-baseline health-related quality of life (HRQOL) [ Time Frame: Parent-study baseline; Visit 3E (End of Study; Week 48) ]Change from parent-study baseline HRQOL as assessed by the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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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:
- Completion of the Samumed study SM04690-OA-11
- Compliance with procedures in study SM04690-OA-11, in the opinion of the Investigator
- Fully understanding study requirements and willingness to comply with study visits and assessments
- Understanding and signing of the informed consent form (ICF) prior to any study-related procedures
Exclusion Criteria:
- 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
- Any contraindications for an intra-articular (IA) injection in the target knee in the opinion of the Investigator
- Any known reason 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)
- Participation in a clinical research trial (other than the prior Samumed 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
- Current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
- 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)
- 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
- Men who are sexually active and of reproductive potential, who have a partner who is capable of becoming pregnant, and who are not willing to use birth control (as outlined in the protocol) during the study period
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
Contacts
| Contact: Samumed Clinical Trials | 1-855-222-0515 | clinicaltrials@samumed.com |
Locations
| United States, Arizona | |
| Research Site | Recruiting |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Research Site | Not yet recruiting |
| Anaheim, California, United States, 92805 | |
| Research Site | Recruiting |
| Pomona, California, United States, 91767 | |
| Research Site | Recruiting |
| San Diego, California, United States, 92103 | |
| Research Site | Recruiting |
| Thousand Oaks, California, United States, 91360 | |
| United States, Colorado | |
| Research Site | Not yet recruiting |
| Denver, Colorado, United States, 80209 | |
| United States, Florida | |
| Research Site | Not yet recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Research Site | Not yet recruiting |
| Hialeah, Florida, United States, 33016 | |
| Research Site | Recruiting |
| Miami Lakes, Florida, United States, 33014 | |
| Research Site | Recruiting |
| Miami, Florida, United States, 33173 | |
| Research Site | Not yet recruiting |
| Orlando, Florida, United States, 32806 | |
| Research Site | Recruiting |
| Port Orange, Florida, United States, 32127 | |
| Research Site | Recruiting |
| West Palm Beach, Florida, United States, 33409 | |
| Research Site | Not yet recruiting |
| Winter Haven, Florida, United States, 33880 | |
| Research Site | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Research Site | Not yet recruiting |
| Marietta, Georgia, United States, 30060 | |
| Research Site | Recruiting |
| Newnan, Georgia, United States, 30265 | |
| Research Site | Not yet recruiting |
| Woodstock, Georgia, United States, 30189 | |
| United States, Illinois | |
| Research Site | Recruiting |
| Gurnee, Illinois, United States, 60031 | |
| Research Site | Recruiting |
| Oak Brook, Illinois, United States, 60523 | |
| United States, Indiana | |
| Research Site | Recruiting |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Louisiana | |
| Research Site | Recruiting |
| New Orleans, Louisiana, United States, 70124 | |
| United States, Michigan | |
| Research Site | Recruiting |
| Bay City, Michigan, United States, 48706 | |
| Research Site | Recruiting |
| Troy, Michigan, United States, 48085 | |
| United States, Missouri | |
| Research Site | Recruiting |
| Hazelwood, Missouri, United States, 63042 | |
| Research Site | Not yet recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Research Site | Recruiting |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Research Site | Not yet recruiting |
| Las Vegas, Nevada, United States, 89199 | |
| United States, New York | |
| Research Site | Recruiting |
| Hartsdale, New York, United States, 10530 | |
| Research Site | Not yet recruiting |
| New York, New York, United States, 10016 | |
| Research Site | Recruiting |
| Rochester, New York, United States, 14609 | |
| United States, North Carolina | |
| Research Site | Not yet recruiting |
| Charlotte, North Carolina, United States, 28209 | |
| Research Site | Not yet recruiting |
| Salisbury, North Carolina, United States, 28144 | |
| Research Site | Not yet recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Research Site | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| Research Site | Not yet recruiting |
| Columbus, Ohio, United States, 43235 | |
| United States, Oklahoma | |
| Research Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, South Carolina | |
| Research Site | Recruiting |
| Fort Mill, South Carolina, United States, 29707 | |
| Research Site | Not yet recruiting |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, South Dakota | |
| Research Site | Recruiting |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Texas | |
| Research Site | Recruiting |
| Carrollton, Texas, United States, 75007 | |
| Research Site | Not yet recruiting |
| Houston, Texas, United States, 77055 | |
| Research Site | Recruiting |
| Plano, Texas, United States, 75075 | |
| Research Site | Not yet recruiting |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Research Site | Not yet recruiting |
| Draper, Utah, United States, 84020 | |
| Research Site | Recruiting |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Research Site | Recruiting |
| Charlottesville, Virginia, United States, 22911 | |
Sponsors and Collaborators
Samumed LLC
Investigators
| Study Director: | Ismail Simsek, MD | Samumed LLC |
| Responsible Party: | Samumed LLC |
| ClinicalTrials.gov Identifier: | NCT04520607 |
| Other Study ID Numbers: |
SM04690-OA-07 |
| First Posted: | August 20, 2020 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Samumed LLC:
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SM04690 Wnt pathway inhibitor osteoarthritis Samumed lorecivivint |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Adavivint Anti-Inflammatory Agents |