Osteoarthritis, KneePhase 1FACT DEVICENCT03491904
To Assess the Patients' Ability to Self-Administer Fasinumab
A Phase 1 study testing Fasinumab AI and Fasinumab PFS in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Fasinumab AI and Fasinumab PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 23 sitesUnited States
- Study dates
- 23 Jan 2019to 15 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Regeneron Research Facility
Atlanta, Georgia, 30342
Regeneron Research Facility
Bristol, Tennessee, 37620
Regeneron Research Facility
Dallas, Texas, 75231
Regeneron Research Facility
Gilbert, Arizona, 85297
Regeneron Research Facility
Glendale, Arizona, 85307
Regeneron Research Facility
Houston, Texas, 77024
Regeneron Research Facility
Houston, Texas, 77089
Regeneron Research Facility
Houston, Texas, 77804
Regeneron Research Facility
Jamaica, New York, 11432
Regeneron Research Facility
Knoxville, Tennessee, 37938
Regeneron Research Facility
Lexington, Kentucky, 40503
Regeneron Research Facility
Lexington, Kentucky, 40504
Regeneron Research Facility
Los Angeles, California, 90029
Regeneron Research Facility
Ocala, Florida, 34471
Regeneron Research Facility
Oklahoma City, Oklahoma, 73114
Regeneron Research Facility
Orlando, Florida, 32822
Regeneron Research Facility
Pinellas Park, Florida, 33781
Regeneron Research Facility
Port Orange, Florida, 32127
Regeneron Research Facility
Statesville, North Carolina, 28625
Regeneron Research Facility
West Des Moines, Iowa, 50265
Regeneron Research Facility
Wheat Ridge, Colorado, 80033
Regeneron Research Facility
Wichita, Kansas, 67205
Regeneron Research Facility
Wilmington, North Carolina, 28401
About this study
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
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
- Being tested
- Fasinumab AI, Fasinumab PFS
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasinumab AIDrug
Also called REGN475
Self-administered with auto injector
Fasinumab PFSDrug
Also called REGN475
Prefilled syringe administered by study staff
| Study group | Role | What they receive |
|---|---|---|
| Auto-injector (AI) | Experimental | Not described Receives: Drug: Fasinumab AI |
| Prefilled syringe (PFS) | Experimental | Not described Receives: Drug: Fasinumab PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline to Week 16
Number of AI associated product technical complaint (PTCs)
Measured: Baseline to Week 16
Number of validated AI associated PTFs
Measured: Baseline to Week 16
Number of patients with an AI associated PTC
Measured: 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
Measured: Baseline to Week 16
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Measured: Baseline to Week 16
Number of participants who experience Adjudicated arthropathy (AA)
As confirmed by independent adjudication
Measured: Through week 36
Number of participants who experience Destructive arthropathy (DA)
As confirmed by independent adjudication
Measured: Through week 36
Number of participants who experience treatment-emergent adverse events (TEAEs)
Measured: Through week 16
Number of participants who experience sympathetic nervous system dysfunction
Measured: Through week 36
Number of participants who experience peripheral sensory adverse events (AEs) that require a neurology or other specialty consultation
Measured: Through week 36
Number of participants who experience all-cause Joint replacement (JR)s
Measured: Through week 36
Number of participants who experienced JR at the telephone survey
Measured: 52 weeks after last dose of study drug
Maximum observed drug concentration (Cmax)
Measured: Up to 36 weeks
Area under the curve from the time of dosing to the end of dosing interval (AUC)
Measured: Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Measured: Up to 36 weeks
Geometric mean ratio of Cmax and AUC for the PFS device (CI) of the geometric mean ratio
Measured: Up to 36 weeks
Incidence of anti-drug antibody (ADA)
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start23 Jan 2019
- Primary completion15 Jan 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491904
- Sponsor's protocol ID
- R475-PN-1602
- Acronym
- FACT DEVICE
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03491904
- Acronym / sponsor ID
- FACT DEVICE / R475-PN-1602
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceutical Industries, Ltd.
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auto-injector (AI) | Experimental | Drug: Fasinumab AI |
| Prefilled syringe (PFS) | Experimental | Drug: Fasinumab PFS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasinumab AIAlso: REGN475Self-administered with auto injector | Drug | Auto-injector (AI) |
| Fasinumab PFSAlso: REGN475Prefilled syringe administered by study staff | Drug | Prefilled syringe (PFS) |
Primary outcome
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
18 secondary outcomes
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
Number of AI associated product technical complaint (PTCs)
Time frame: Baseline to Week 16
Number of validated AI associated PTFs
Time frame: Baseline to Week 16
Number of patients with an AI associated PTC
Time frame: Baseline to Week 16
Number of AI use-related errors
Time frame: Baseline to Week 16
Patient satisfaction with the AI as assessed using the Self-Injection Assessment Questionnaire (SIAQ)
Time frame: Baseline to Week 16
Number of participants who experience Adjudicated arthropathy (AA)
Time frame: Through week 36
Number of participants who experience Destructive arthropathy (DA)
Time frame: Through week 36
Number of participants who experience treatment-emergent adverse events (TEAEs)
Time frame: Through week 16
Number of participants who experience sympathetic nervous system dysfunction
Time frame: 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
Number of participants who experience all-cause Joint replacement (JR)s
Time frame: Through week 36
Number of participants who experienced JR at the telephone survey
Time frame: 52 weeks after last dose of study drug
Maximum observed drug concentration (Cmax)
Time frame: 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
Geometric mean ratio of Cmax and AUC for the AI device (CI) of the geometric mean ratio
Time frame: 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
Incidence of anti-drug antibody (ADA)
Time frame: Up to 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fasinumab AI and Fasinumab PFS in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.