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A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
NCT03161093 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Conditions Studied
Interventions
- DRUG Naproxen
- DRUG Fasinumab
- DRUG Fasinumab-matching placebo
- DRUG Naproxen-matching placebo
Study Locations (20)
Florida
- Arthritis and Rheumatic Disease Specialties — Aventura
- Jacksonville Center for Clinical Research — Jacksonville
- Clinical Neuroscience Solutions, Inc. — Jacksonville
- Sensible Healthcare — Ocoee
- Clinical Neuroscience Solutions, Inc. — Orlando
- Jewett Orthopaedic Clinic — Orlando
- Lovelace Scientific Resources — Venice
California
- Medvin Clinical Research — Covina
- TriWest Research Associates, LLC — El Cajon
- BioSolutions Clinical Research — La Mesa
- Pacific Arthritis Care Center — Los Angeles
- Artemis Institute for Clinical Research — San Diego
- Artemis Clinical Research — San Marcos
Arizona
- Arizona Arthritis & Rheumatology Research, PLLC — Mesa
- Arizona Research Center — Phoenix
- Tucson Orthopaedic Research Center — Tucson
Colorado
- Lynn Institute of Denver — Aurora
- Lynn Institute of the Rockies — Colorado Springs
- Panorama Orthopedics & Spine Center — Golden
Arkansas
- Baptist Health Center for Clinical Research — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,307 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2021-08-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161093
The ClinicalTrials.gov registry entry for NCT03161093 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 4 interventions — of which Naproxen is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03161093 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03161093 about?
NCT03161093 is a clinical study titled "A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip". The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared ...
What is the current status of trial NCT03161093?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,307 participants. The study started on 2017-08-17. Estimated completion is 2021-08-27.
What conditions does trial NCT03161093 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Osteoarthritis, Hip. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03161093?
The interventions under investigation include: Naproxen (DRUG), Fasinumab (DRUG), Fasinumab-matching placebo (DRUG), Naproxen-matching placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03161093?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03161093 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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