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NCT02951026
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
trial testing Not applicable (no therapy is administered as part of this study) in Osteoarthritis in 703 participants. Completed in 31 October 2019.
31 October 2019
Quick facts
| Lead sponsor | Biosplice Therapeutics, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 703 |
| Start date | 19 September 2016 |
| Primary completion | 31 October 2019 |
| Estimated completion | 31 October 2019 |
| Sites | 62 locations across United States |
Drugs / interventions tested
- Not applicable (no therapy is administered as part of this study)
Conditions studied
- Osteoarthritis — all drugs for Osteoarthritis →
Sponsor
Biosplice Therapeutics, Inc. — full company profile →
Who can join
Adults 40 to 80, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial.
Swearingen CJ, Tambiah JRS, Simsek I, Ghandehari H, et al · · 2025 · cited 4× · PMID 39755925 · DOI 10.1007/s40744-024-00731-9 -
World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2021): Oral Communication Abstracts
· 2021
Verify or expand the search:
- PubMed search for NCT02951026
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis
Currently open trials in the same condition.
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- NCT07118501 — A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System · recruiting
- NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
- NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
- NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
Other Biosplice Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT05603754 — A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatm · Phase 3 · completed
- NCT05084859 — A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With H · Phase 1 · terminated
- NCT04931667 — 3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Knee Osteoarthritis · Phase 3 · terminated
- NCT04598542 — Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers · Phase 1 · completed
- NCT04520607 — A Long-Term Safety and Efficacy Study of Lorecivivint in Subjects With Osteoarthritis of the Knee · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02951026 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biosplice Therapeutics, Inc.
- Last refreshed: 17 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02951026.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing