A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis (STRIDES)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Biosplice Therapeutics, Inc.
- Study ID
- NCT05603754
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Lorecivivint — DRUGOne intra-articular injection of 0.07 mg lorecivivint in 2 mL vehicle
- Placebo — DRUGOne intra-articular injection of 0 mg lorecivivint in 2 mL vehicle
Study Details
This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of lorecivivint injected intra-articularly (IA) into the target (most painful) knee joint of moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg lorecivivint per 2 mL injection. This study will utilize standard outcomes to evaluate the safety and efficacy of lorecivivint.
Key Dates
- First listed
- Nov 3, 2022
- Start date
- Nov 18, 2022
- Status verified
- Jul 2024
- Primary completion
- Feb 20, 2024
- Completion
- Feb 20, 2024
Study Design
- Enrollment
- 496 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LorecivivintHealthcare professional-administered intra-articular injection; performed on Day 1.
- Placebo Comparator: VehicleHealthcare professional-administered intra-articular injection; performed on Day 1.
Primary Outcome Measure
Change from baseline OA pain in the target knee as assessed by weekly average of daily pain numeric rating scale (NRS) at Week 12 [ Time Frame: Baseline and Week 12 ]
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