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

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: Completed
• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Intervention / Treatment: Drug: Fasinumab AI; Drug: Fasinumab PFS

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	Baseline to Week 16

Secondary Outcome Measures

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)		Baseline to Week 16
Number of AI associated product technical complaint (PTCs)		Baseline to Week 16
Number of validated AI associated PTFs		Baseline to Week 16
Number of patients with an AI associated PTC		Baseline to Week 16
Number of AI use-related errors	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)		Baseline to Week 16
Number of participants who experience Adjudicated arthropathy (AA)	As confirmed by independent adjudication	Through week 36
Number of participants who experience Destructive arthropathy (DA)	As confirmed by independent adjudication	Through week 36
Number of participants who experience treatment-emergent adverse events (TEAEs)		Through week 16
Number of participants who experience sympathetic nervous system dysfunction		Through week 36
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation		Through week 36
Number of participants who experience all-cause Joint replacement (JR)s		Through week 36
Number of participants who experienced JR at the telephone survey		52 weeks after last dose of study drug
Maximum observed drug concentration (Cmax)		Up to 36 weeks
Area under the curve from the time of dosing to the end of dosing interval (AUC)		Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio		Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio		Up to 36 weeks
Incidence of anti-drug antibody (ADA)		Up to 36 weeks

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Teva Pharmaceutical Industries, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Fasinumab
• Other Study ID 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