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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable (no therapy is administered as part of this study) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 6. AEs of interest include those related to either knee and/or an AE that is a newly diagnosed chronic condition requiring treatment (e.g., hypertension, hyperlipidemia, diabetes). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2 or phase 3 study.
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| Name | Affiliation | Role |
|---|---|---|
| Yusuf Yazici, M.D. | Biosplice Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39755925 | Derived | 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. |
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|
| Month 6 |
| AEs of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 12. | Month 12 |
| AEs of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 24. | Month 24 |
| AEs of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 36. | Month 36 |
| AEs of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 48. | Month 48 |
| AEs of interest | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 60. | Month 60 |
| Incidence and incidence rate of total knee replacement (TKR) | Compare the incidence and incidence rate of TKR in the previously injected knee occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60. | Month 60 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in joint space width (JSW) | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in WOMAC total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in WOMAC total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in WOMAC total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in WOMAC total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in WOMAC total score | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in WOMAC pain subscore | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in WOMAC function subscore | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in Physician Global Assessment | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. | Baseline and Month 6 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. | Baseline and Month 12 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 24. | Baseline and Month 24 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 36. | Baseline and Month 36 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 48. | Baseline and Month 48 |
| Change in Patient Global Assessment | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 60. | Baseline and Month 60 |
| Oro Valley |
| Arizona |
| United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Canoga Park | California | United States |
| Research Site | Carmichael | California | United States |
| Research Site | Cerritos | California | United States |
| Research Site | El Cajon | California | United States |
| Research Site | Gold River | California | United States |
| Research Site | La Mesa | California | United States |
| Research Site | Palm Springs | California | United States |
| Research Site | Rancho Mirage | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Marcos | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Boulder | Colorado | United States |
| Research Site | Stamford | Connecticut | United States |
| Research Site | Trumbull | Connecticut | United States |
| Research Site | Waterbury | Connecticut | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | Coral Gables | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Edgewater | Florida | United States |
| Research Site | Lauderdale Lakes | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Woodstock | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Newton | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lexington | Kentucky | United States |
| Research Site | Frederick | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Troy | Michigan | United States |
| Research Site | City of Saint Peters | Missouri | United States |
| Research Site | Kansas City | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Lincoln | Nebraska | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Orchard Park | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Charlotte | North Carolina | United States |
| Research Site | High Point | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Salisbury | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Duncansville | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Mt. Pleasant | South Carolina | United States |
| Research Site | Rapid City | South Dakota | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Bedford | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Angelo | Texas | United States |
| Research Site | Layton | Utah | United States |
| Research Site | Arlington | Virginia | United States |
| Research Site | Charlottesville | Virginia | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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