Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extension Study Evaluating the Safety and Efficacy of a Second Year of Use 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520607
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

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

Detailed Description:
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.

Layout table for study information
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 related topics: Osteoarthritis

Arm Intervention/treatment
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)
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

Placebo Comparator: Vehicle
One intra-articular injection of 0 mg lorecivivint in 2 ml vehicle (same treatment as in the parent-study)
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 :
  1. 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 :
  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 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.

  3. 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.

  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.

  5. 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

  6. 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."

  7. 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."

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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 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
  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
  8. 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
Layout table for location contacts
Contact: Samumed Clinical Trials 1-855-222-0515 clinicaltrials@samumed.com

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Ismail Simsek, MD Samumed LLC
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samumed LLC:
SM04690
Wnt pathway inhibitor
osteoarthritis
Samumed
lorecivivint
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adavivint
Anti-Inflammatory Agents