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To Assess the Patients' Ability to Self-Administer Fasinumab
NCT03491904 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to administer fasinumab at home by patients or their caregivers, as measured by collecting 12 weeks of actual-use data on the technical performance of the device. The secondary objectives of the study are: * To evaluate the successful injection of fasinumab by patients or their caregivers using the AI in an unsupervised setting * To evaluate patient/caregiver satisfaction with the AI for fasinumab injection in an unsupervised setting * To evaluate exposure in serum for fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program * To characterize the safety, tolerability, and immunogenicity of fasinumab administered by patients or their caregivers using an AI in an unsupervised setting, or fasinumab administered by study staff using a PFS that has been used in the phase 3 program
Conditions Studied
Interventions
- DRUG Fasinumab AI
- DRUG Fasinumab PFS
Study Locations (20)
Florida
- Regeneron Research Facility — Ocala
- Regeneron Research Facility — Orlando
- Regeneron Research Facility — Pinellas Park
- Regeneron Research Facility — Port Orange
Arizona
- Regeneron Research Facility — Gilbert
- Regeneron Research Facility — Glendale
Kentucky
- Regeneron Research Facility — Lexington
- Regeneron Research Facility — Lexington
North Carolina
- Regeneron Research Facility — Statesville
- Regeneron Research Facility — Wilmington
Tennessee
- Regeneron Research Facility — Bristol
- Regeneron Research Facility — Knoxville
California
- Regeneron Research Facility — Los Angeles
Colorado
- Regeneron Research Facility — Wheat Ridge
Georgia
- Regeneron Research Facility — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-01-23 |
| Est. Completion | 2020-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03491904
The ClinicalTrials.gov registry entry for NCT03491904 describes a study currently listed as completed. It is categorized as Phase 1, 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 100 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 2 interventions — of which Fasinumab AI 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: NCT03491904 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Arizona, Kentucky. 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 NCT03491904 about?
NCT03491904 is a clinical study titled "To Assess the Patients' Ability to Self-Administer Fasinumab". The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to administer fasinumab at home by patients or their caregivers, as measured by collecting 12 weeks of actual-use data on the technical performance of the device. The secondary objectives of the study are: * ...
What is the current status of trial NCT03491904?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2019-01-23. Estimated completion is 2020-12-15.
What conditions does trial NCT03491904 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 NCT03491904?
The interventions under investigation include: Fasinumab AI (DRUG), Fasinumab PFS (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03491904?
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 NCT03491904 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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