To Assess the Patients' Ability to Self-Administer Fasinumab

NCT03491904 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: R475-PN-1602
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 23

Brief 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

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 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

  Baseline to Week 16

Study Arms (2)

Auto-injector (AI)

EXPERIMENTAL

Drug: Fasinumab AI

Prefilled syringe (PFS)

EXPERIMENTAL

Drug: Fasinumab PFS

Interventions

Fasinumab AI DRUG

Self-administered with auto injector

Also known as: REGN475

Auto-injector (AI)

Fasinumab PFS DRUG

Prefilled syringe administered by study staff

Also known as: REGN475

Prefilled syringe (PFS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments
• A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
• 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

You may not qualify if:

• 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
• 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
• Trauma to the index joint within 3 months prior to the screening visit
• Signs or symptoms of carpal tunnel syndrome within 6 months of screening
• Patient is not a candidate for MRI

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Teva Pharmaceutical Industries, Ltd.: collaborator

Study Sites (23)

Regeneron Research Facility

Gilbert, Arizona, 85297, United States

Location

Regeneron Research Facility

Glendale, Arizona, 85307, United States

Location

Regeneron Research Facility

Los Angeles, California, 90029, United States

Location

Regeneron Research Facility

Wheat Ridge, Colorado, 80033, United States

Location

Regeneron Research Facility

Ocala, Florida, 34471, United States

Location

Regeneron Research Facility

Orlando, Florida, 32822, United States

Location

Regeneron Research Facility

Pinellas Park, Florida, 33781, United States

Location

Regeneron Research Facility

Port Orange, Florida, 32127, United States

Location

Regeneron Research Facility

Atlanta, Georgia, 30342, United States

Location

Regeneron Research Facility

West Des Moines, Iowa, 50265, United States

Location

Regeneron Research Facility

Wichita, Kansas, 67205, United States

Location

Regeneron Research Facility

Lexington, Kentucky, 40503, United States

Location

Regeneron Research Facility

Lexington, Kentucky, 40504, United States

Location

Regeneron Research Facility

Jamaica, New York, 11432, United States

Location

Regeneron Research Facility

Statesville, North Carolina, 28625, United States

Location

Regeneron Research Facility

Wilmington, North Carolina, 28401, United States

Location

Regeneron Research Facility

Oklahoma City, Oklahoma, 73114, United States

Location

Regeneron Research Facility

Bristol, Tennessee, 37620, United States

Location

Regeneron Research Facility

Knoxville, Tennessee, 37938, United States

Location

Regeneron Research Facility

Dallas, Texas, 75231, United States

Location

Regeneron Research Facility

Houston, Texas, 77024, United States

Location

Regeneron Research Facility

Houston, Texas, 77089, United States

Location

Regeneron Research Facility

Houston, Texas, 77804, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

fasinumab

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 9, 2018
• Study Start: January 23, 2019
• Primary Completion: January 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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).

Locations

US (23)