Extension Study Evaluating the Safety and Efficacy of a Second Year of Use of Lorecivivint in Subjects With Osteoarthritis of the Knee
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 41 years and 81 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04520607
- Collaborators
- Not Provided
- Investigators
- Study Director: Ismail Simsek, MD Biosplice Therapeutics, Inc.
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