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NCT03956550 · ClinicalTrials.gov registry record · Phase 2
A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 259
- Enrollment target
NCT03956550: Clinical Trial Phase 2 study, sponsored by Regeneron Pharmaceuticals.
NCT03956550 is a Phase 2 study that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 259 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03956550, a Phase 2 study, was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 259 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. The secondary objectives of the study are: * To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks * To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks * To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
Primary Outcome
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of
Interventions
- DRUG Matching Placebo
- DRUG REGN5069
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2020-10-29 |
| Phase | Phase 2 |
Why NCT03956550 stopped before completion
NCT03956550 is an interventional study that assigns participants to a tested intervention. The registered 259 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 (95% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT03956550 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03956550 about?
NCT03956550 is a clinical study titled "A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee". The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. The secondary objectives of the study...
What is the current status of trial NCT03956550?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2019-05-21. Estimated completion is 2020-10-29.
What interventions are being tested in trial NCT03956550?
The interventions under investigation include: Matching Placebo (DRUG), REGN5069 (DRUG).
Who is sponsoring clinical trial NCT03956550?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03956550's enrollment target sits among peer trials
259 212th of 2000 higher than 1,789 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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