To Assess the Patients' Ability to Self-Administer Fasinumab (FACT DEVICE)

March 2, 2021 updated by: Regeneron Pharmaceuticals

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Regeneron Research Facility
      • Glendale, Arizona, United States, 85307
        • Regeneron Research Facility
    • California
      • Los Angeles, California, United States, 90029
        • Regeneron Research Facility
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Regeneron Research Facility
    • Florida
      • Ocala, Florida, United States, 34471
        • Regeneron Research Facility
      • Orlando, Florida, United States, 32822
        • Regeneron Research Facility
      • Pinellas Park, Florida, United States, 33781
        • Regeneron Research Facility
      • Port Orange, Florida, United States, 32127
        • Regeneron Research Facility
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Regeneron Research Facility
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Regeneron Research Facility
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Regeneron Research Facility
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Regeneron Research Facility
      • Lexington, Kentucky, United States, 40504
        • Regeneron Research Facility
    • New York
      • Jamaica, New York, United States, 11432
        • Regeneron Research Facility
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Regeneron Research Facility
      • Wilmington, North Carolina, United States, 28401
        • Regeneron Research Facility
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Regeneron Research Facility
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Regeneron Research Facility
      • Knoxville, Tennessee, United States, 37938
        • Regeneron Research Facility
    • Texas
      • Dallas, Texas, United States, 75231
        • Regeneron Research Facility
      • Houston, Texas, United States, 77024
        • Regeneron Research Facility
      • Houston, Texas, United States, 77089
        • Regeneron Research Facility
      • Houston, Texas, United States, 77804
        • Regeneron Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
  2. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale score of ≥4 at both the screening and randomization visits
  3. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
  4. A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
  5. History of regular use of analgesic medications for OA pain (defined as an average of 4 days per week over the 4 weeks prior to the screening visit), including NSAIDs, selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof

Key Exclusion Criteria:

  1. History or presence at the screening visit of non-OA inflammatory joint disease (eg,rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout, spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5 years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
  2. History or presence on imaging of arthropathy (osteonecrosis, subchondral insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip dislocation is eligible), knee dislocation (patella dislocation is eligible), congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation of collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures during the screening period
  3. Trauma to the index joint within 3 months prior to the screening visit
  4. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  5. Patient is not a candidate for MRI

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Auto-injector (AI)
Drug: Fasinumab AI
Self-administered with auto injector
Other Names:
  • REGN475
Experimental: Prefilled syringe (PFS)
Drug: Fasinumab PFS
Prefilled syringe administered by study staff
Other Names:
  • REGN475

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of AI associated product technical complaint (PTCs)
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of validated AI associated PTFs
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of patients with an AI associated PTC
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of AI use-related errors
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
Baseline to Week 16
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Time Frame: Baseline to Week 16
Baseline to Week 16
Number of participants who experience Adjudicated arthropathy (AA)
Time Frame: Through week 36
As confirmed by independent adjudication
Through week 36
Number of participants who experience Destructive arthropathy (DA)
Time Frame: Through week 36
As confirmed by independent adjudication
Through week 36
Number of participants who experience treatment-emergent adverse events (TEAEs)
Time Frame: Through week 16
Through week 16
Number of participants who experience sympathetic nervous system dysfunction
Time Frame: Through week 36
Through week 36
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
Time Frame: Through week 36
Through week 36
Number of participants who experience all-cause Joint replacement (JR)s
Time Frame: Through week 36
Through week 36
Number of participants who experienced JR at the telephone survey
Time Frame: 52 weeks after last dose of study drug
52 weeks after last dose of study drug
Maximum observed drug concentration (Cmax)
Time Frame: Up to 36 weeks
Up to 36 weeks
Area under the curve from the time of dosing to the end of dosing interval (AUC)
Time Frame: Up to 36 weeks
Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Time Frame: Up to 36 weeks
Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
Time Frame: Up to 36 weeks
Up to 36 weeks
Incidence of anti-drug antibody (ADA)
Time Frame: Up to 36 weeks
Up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Teva Pharmaceutical Industries, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R475-PN-1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

Individual de-identified participant data will be made available once the indication has been approved by a regulatory body, if there is participant consent and there is not a reasonable likelihood of participant re-identification

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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