A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Osteoarthritis of the Knee, Pain
In brief
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
Key facts
- Study ID
- NCT03956550
- Run by
- Regeneron Pharmaceuticals
- People needed
- 259
- Starts
- 2019-05-21
- Expected to finish
- 2020-10-29
- Last updated by the study team
- 2021-07-01
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Regeneron Study Site — DeLand, Florida, United States
- Regeneron Study Site — Jupiter, Florida, United States
- Regeneron Study Site — Miami, Florida, United States
- Regeneron Study Site — Charleston, South Carolina, United States
- Regeneron Study Site — Tbilisi, Georgia
- Regeneron Study Site — Chisinau, Moldova
- Regeneron Study Site — Lublin, Lublin Voivodeship, Poland
- Regeneron Study Site — Zamość, Lublin Voivodeship, Poland
- Regeneron Study Site — Warsaw, Masovian Voivodeship, Poland
- Regeneron Study Site — Bialystok, Podlaskie Voivodeship, Poland
- Regeneron Study Site — Zgierz, Łódź Voivodeship, Poland
- Regeneron Study Site — Kyiv, Ukraine
Full record on ClinicalTrials.gov
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