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NCT03727022 · ClinicalTrials.gov registry record · Phase 2
Safety and Bone Health Study 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
- 101
- Enrollment target
NCT03727022: Completed Phase 2 study, sponsored by Biosplice Therapeutics.
NCT03727022 is a Phase 2 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727022, a Phase 2 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study was to provide an initial safety evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately to severely symptomatic osteoarthritis (OA) subjects. Subjects who completed this 52-week long study were invited to enter the extension phase for an additional 52 weeks of treatment.
Primary Outcome
Evaluate change in total bone mineral density (BMD) from baseline in the treated knee compared to placebo by quantitative computed tomography (qCT)
Interventions
- DRUG Placebo
- DRUG SM04690
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2021-08-18 |
| Phase | Phase 2 |
What the finished NCT03727022 record still lists
NCT03727022 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03727022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03727022 about?
NCT03727022 is a clinical study titled "Safety and Bone Health Study of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis". The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study was to provide an initial safety evaluation of two intra-articular (IA) injections of SM04690 (each at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee of moderately t...
What is the current status of trial NCT03727022?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2018-11-28. Estimated completion is 2021-08-18.
What interventions are being tested in trial NCT03727022?
The interventions under investigation include: Placebo (DRUG), SM04690 (DRUG).
Who is sponsoring clinical trial NCT03727022?
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 NCT03727022's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 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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