Clinical trial NCT03491904: To Assess the Patients' Ability to Self-Administer Fasinumab
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2018-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
timeFrame: Baseline to Week 16
measure: Number of AI associated product technical complaint (PTCs)
timeFrame: Baseline to Week 16
measure: Number of validated AI associated PTFs
timeFrame: Baseline to Week 16
measure: Number of patients with an AI associated PTC
timeFrame: Baseline to Week 16
measure: Number of AI use-related errors
timeFrame: Baseline to Week 16
measure: Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
timeFrame: Baseline to Week 16
measure: Number of participants who experience Adjudicated arthropathy (AA)
timeFrame: Through week 36
measure: Number of participants who experience Destructive arthropathy (DA)
timeFrame: Through week 36
measure: Number of participants who experience treatment-emergent adverse events (TEAEs)
timeFrame: Through week 16
measure: Number of participants who experience sympathetic nervous system dysfunction
timeFrame: Through week 36
measure: Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
timeFrame: Through week 36
measure: Number of participants who experience all-cause Joint replacement (JR)s
timeFrame: Through week 36
measure: Number of participants who experienced JR at the telephone survey
timeFrame: 52 weeks after last dose of study drug
measure: Maximum observed drug concentration (Cmax)
timeFrame: Up to 36 weeks
measure: Area under the curve from the time of dosing to the end of dosing interval (AUC)
timeFrame: Up to 36 weeks
measure: Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
timeFrame: Up to 36 weeks
measure: Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
timeFrame: Up to 36 weeks
measure: Incidence of anti-drug antibody (ADA)
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Regeneron Research Facility
state: Arizona
city: Glendale
country: United States
facility: Regeneron Research Facility
state: Arizona
city: Los Angeles
country: United States
facility: Regeneron Research Facility
state: California
city: Wheat Ridge
country: United States
facility: Regeneron Research Facility
state: Colorado
city: Ocala
country: United States
facility: Regeneron Research Facility
state: Florida
city: Orlando
country: United States
facility: Regeneron Research Facility
state: Florida
city: Pinellas Park
country: United States
facility: Regeneron Research Facility
state: Florida
city: Port Orange
country: United States
facility: Regeneron Research Facility
state: Florida
city: Atlanta
country: United States
facility: Regeneron Research Facility
state: Georgia
city: West Des Moines
country: United States
facility: Regeneron Research Facility
state: Iowa
city: Wichita
country: United States
facility: Regeneron Research Facility
state: Kansas
city: Lexington
country: United States
facility: Regeneron Research Facility
state: Kentucky
city: Lexington
country: United States
facility: Regeneron Research Facility
state: Kentucky
city: Jamaica
country: United States
facility: Regeneron Research Facility
state: New York
city: Statesville
country: United States
facility: Regeneron Research Facility
state: North Carolina
city: Wilmington
country: United States
facility: Regeneron Research Facility
state: North Carolina
city: Oklahoma City
country: United States
facility: Regeneron Research Facility
state: Oklahoma
city: Bristol
country: United States
facility: Regeneron Research Facility
state: Tennessee
city: Knoxville
country: United States
facility: Regeneron Research Facility
state: Tennessee
city: Dallas
country: United States
facility: Regeneron Research Facility
state: Texas
city: Houston
country: United States
facility: Regeneron Research Facility
state: Texas
city: Houston
country: United States
facility: Regeneron Research Facility
state: Texas
city: Houston
country: United States
facility: Regeneron Research Facility
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: