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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

Completed Last updated 17 April 2020
What this trial tests

trial testing Not applicable (no therapy is administered as part of this study) in Osteoarthritis in 703 participants. Completed in 31 October 2019.

Timeline
19 September 2016
Primary endpoint
31 October 2019
31 October 2019

Quick facts

Lead sponsorBiosplice Therapeutics, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment703
Start date19 September 2016
Primary completion31 October 2019
Estimated completion31 October 2019
Sites62 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2021): Oral Communication Abstracts
    · 2021

Verify or expand the search:

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

Other Biosplice Therapeutics, Inc. trials

Trials by the same sponsor.

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Data sources for this page

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