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NCT03491904 · ClinicalTrials.gov registry record · Phase 1

To Assess the Patients' Ability to Self-Administer Fasinumab

A Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
100
Enrollment target
20
Study locations

NCT03491904: Completed Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip, sponsored by Regeneron Pharmaceuticals.

NCT03491904 is a Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 100 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03491904, a Phase 1 study of Osteoarthritis, Knee and Osteoarthritis, Hip, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target
20
Study locations

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

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

FieldValue
Enrollment Target 100 participants
Start Date 2019-01-23
Est. Completion 2020-12-15
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

What the finished NCT03491904 record still lists

NCT03491904 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (80% lower).

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.

NCT03491904 names 20 study sites across 13 states, led by Florida, Arizona, Kentucky.

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.

What interventions are being tested in trial NCT03491904?

The interventions under investigation include: Fasinumab AI (DRUG), Fasinumab PFS (DRUG).

Who is sponsoring clinical trial NCT03491904?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Osteoarthritis, Knee

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03491904's enrollment target sits among peer trials

100 65th of 112 higher than 44 of 112 other Osteoarthritis, Knee trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis, Knee 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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Source: ClinicalTrials.gov NCT03491904, the US trial registry maintained by the National Library of Medicine. NCT03491904 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.