Fasinumab AI
DrugSelf-administered with auto injector
Other names: REGN475
NCT Number: NCT03491904
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
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Regeneron Research Facility, Gilbert, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Self-administered with auto injector
Other names: REGN475
Prefilled syringe administered by study staff
Other names: REGN475
Time frame: Baseline to Week 16
Time frame: Baseline to Week 16
Time frame: Baseline to Week 16
Time frame: Baseline to Week 16
Time frame: Baseline to Week 16
Time frame: Baseline to Week 16
Including but not limited to improper storage, inappropriate use of the device, dosing schedule mistakes, and user handling mistakes
Time frame: Baseline to Week 16
Time frame: Through week 36
As confirmed by independent adjudication
Time frame: Through week 36
As confirmed by independent adjudication
Time frame: Through week 16
Time frame: Through week 36
Time frame: Through week 36
Time frame: Through week 36
Time frame: 52 weeks after last dose of study drug
Time frame: Up to 36 weeks
Time frame: Up to 36 weeks
Time frame: Up to 36 weeks
Time frame: Up to 36 weeks
Time frame: Up to 36 weeks
Regeneron Pharmaceuticals
Industry
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
Acronym: FACT DEVICE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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