An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
1 other identifier
observational
703
1 country
62
Brief Summary
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Typical duration for all trials
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedApril 17, 2020
April 1, 2020
3.1 years
October 7, 2016
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence rate of serious adverse events (SAEs)
Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60
Month 60
Secondary Outcomes (43)
Adverse events (AEs) of interest
Month 6
AEs of interest
Month 12
AEs of interest
Month 24
AEs of interest
Month 36
AEs of interest
Month 48
- +38 more secondary outcomes
Study Arms (4)
0.03mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
0.07mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
0.23mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
Placebo (previously injected)
Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study.
Interventions
No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study.
Eligibility Criteria
Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2 or phase 3 study.
You may qualify if:
- Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies
- Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
- Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
You may not qualify if:
- Unable to undergo the radiograph procedures detailed within the protocol
- Partial or complete joint replacement in the target knee
- Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
- Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Research Site
Birmingham, Alabama, United States
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Oro Valley, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Carmichael, California, United States
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Cerritos, California, United States
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El Cajon, California, United States
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Gold River, California, United States
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La Mesa, California, United States
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Palm Springs, California, United States
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Rancho Mirage, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Marcos, California, United States
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Spring Valley, California, United States
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Boulder, Colorado, United States
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Stamford, Connecticut, United States
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Trumbull, Connecticut, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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DeLand, Florida, United States
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Edgewater, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Marietta, Georgia, United States
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Woodstock, Georgia, United States
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Chicago, Illinois, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Frederick, Maryland, United States
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Boston, Massachusetts, United States
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Troy, Michigan, United States
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City of Saint Peters, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Orchard Park, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Houston, Texas, United States
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San Angelo, Texas, United States
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Layton, Utah, United States
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Arlington, Virginia, United States
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Charlottesville, Virginia, United States
Related Publications (1)
Swearingen CJ, Tambiah JRS, Simsek I, Ghandehari H, Kennedy S, Yazici Y. Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial. Rheumatol Ther. 2025 Feb;12(1):157-171. doi: 10.1007/s40744-024-00731-9. Epub 2025 Jan 4.
PMID: 39755925DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yusuf Yazici, M.D.
Biosplice Therapeutics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
November 1, 2016
Study Start
September 19, 2016
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
April 17, 2020
Record last verified: 2020-04