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NCT03122860 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
A Phase 2 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 700
- Enrollment target
NCT03122860: Completed Phase 2 study, sponsored by Biosplice Therapeutics.
NCT03122860 is a Phase 2 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 700 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03122860, a Phase 2 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 700 participants
- Enrollment target
Study Summary
This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).
Primary Outcome
Change from baseline OA pain in the target knee as assessed by the weekly average of daily pain NRS at Week 24. The pain NRS is an 11-point scale \[0-10\] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain (pain as bad as one can imagine).
Interventions
- OTHER Placebo
- OTHER Sham
- DRUG SM04690
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
What the finished NCT03122860 record still lists
NCT03122860 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (426% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03122860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03122860 about?
NCT03122860 is a clinical study titled "A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis". This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based...
What is the current status of trial NCT03122860?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 700 participants. The study started on 2017-04-24. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT03122860?
The interventions under investigation include: Placebo (OTHER), Sham (OTHER), SM04690 (DRUG).
Who is sponsoring clinical trial NCT03122860?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03122860's enrollment target sits among peer trials
700 46th of 2000 higher than 1,955 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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