To Assess the Patients' Ability to Self-Administer Fasinumab
Public ClinicalTrials.gov record NCT03491904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab Using an Auto-Injector and to Characterize the Pharmacokinetics of Fasinumab Using Two Different Presentations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03491904
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 23, 2019 (Actual)
- Primary completion
- Jan 15, 2020 (Actual)
- Completion
- Dec 15, 2020 (Actual)
- Last update posted
- Mar 3, 2021
2019 – 2020
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Research Facility | Gilbert | Arizona | 85297 | — |
| Regeneron Research Facility | Glendale | Arizona | 85307 | — |
| Regeneron Research Facility | Los Angeles | California | 90029 | — |
| Regeneron Research Facility | Wheat Ridge | Colorado | 80033 | — |
| Regeneron Research Facility | Ocala | Florida | 34471 | — |
| Regeneron Research Facility | Orlando | Florida | 32822 | — |
| Regeneron Research Facility | Pinellas Park | Florida | 33781 | — |
| Regeneron Research Facility | Port Orange | Florida | 32127 | — |
| Regeneron Research Facility | Atlanta | Georgia | 30342 | — |
| Regeneron Research Facility | West Des Moines | Iowa | 50265 | — |
| Regeneron Research Facility | Wichita | Kansas | 67205 | — |
| Regeneron Research Facility | Lexington | Kentucky | 40503 | — |
| Regeneron Research Facility | Lexington | Kentucky | 40504 | — |
| Regeneron Research Facility | Jamaica | New York | 11432 | — |
| Regeneron Research Facility | Statesville | North Carolina | 28625 | — |
| Regeneron Research Facility | Wilmington | North Carolina | 28401 | — |
| Regeneron Research Facility | Oklahoma City | Oklahoma | 73114 | — |
| Regeneron Research Facility | Bristol | Tennessee | 37620 | — |
| Regeneron Research Facility | Knoxville | Tennessee | 37938 | — |
| Regeneron Research Facility | Dallas | Texas | 75231 | — |
| Regeneron Research Facility | Houston | Texas | 77024 | — |
| Regeneron Research Facility | Houston | Texas | 77089 | — |
| Regeneron Research Facility | Houston | Texas | 77804 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03491904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03491904 live on ClinicalTrials.gov.