Clinical trial NCT03691974: Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2018-10-02
Enrollment: 180
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 of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee.

The secondary objectives of the study are to:

* Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
* Evaluate the safety and tolerability of fasinumab compared to placebo in participants with pain due to OA of the hip or knee
* Characterize the concentrations of fasinumab in serum in participants with pain due to OA of the hip or knee
* Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip or knee.


Eligibility criteria: Key Inclusion Criteria:

1. A clinical diagnosis of 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 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 oral nonsteroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or combinations thereof
5. Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator

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 or 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. History or presence of signs or symptoms of compression neuropathy, including carpal tunnel syndrome or sciatica
5. Participant is not a candidate for Magnetic Resonance Imaging (MRI)
6. Poorly controlled diabetes
7. Known history of human immunodeficiency virus (HIV) infection
8. Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or herpes simplex virus encephalitis
9. History of poorly controlled hypertension
10. Known history of infection with hepatitis B or C virus

Note: Other protocol defined Inclusion/Exclusion apply

Primary outcomes:
measure: Change From Baseline in Peroneal Motor Nerve Conduction Velocity at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Peroneal Motor Nerve Action Potential Amplitude at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sural Sensory Nerve Conduction Velocity at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Sural Sensory Nerve Action Potential Amplitude at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Ulnar Sensory Nerve Conduction Velocity at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Ulnar Sensory Nerve Action Potential Amplitude at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in WOMAC Physical Function Subscale Score at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 16
measure: Number of Adjudicated Arthropathy (AA) Events
timeFrame: Baseline up to follow-up (Week 36)
measure: Number of AA Events Meeting Destructive Arthropathy (DA) Criteria
timeFrame: Baseline up to follow-up (Week 36)
measure: Number of Sympathetic Nervous System (SNS) Dysfunction Events
timeFrame: Baseline up to follow-up (Week 36)
measure: Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation
timeFrame: Baseline up to follow-up (Week 36)
measure: Number of All-Cause Joint Replacement (JR) Surgery Events
timeFrame: Baseline up to follow-up (Week 36)
measure: Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
timeFrame: Baseline up to EOS (Week 64)
measure: Serum Concentration of Functional Fasinumab
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 16 and 36
measure: Number of Participants With At-least One Positive Anti-Drug Antibody (ADA)
timeFrame: Baseline up to follow-up period (Week 36)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Regeneron Study Site
state: Arizona
city: Glendale
country: United States
facility: Regeneron Study Site
state: Arizona
city: Phoenix
country: United States
facility: Regeneron Study Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Study Site
state: Arizona
city: Anaheim
country: United States
facility: Regeneron Study Site
state: California
city: Clearwater
country: United States
facility: Regeneron Study Site
state: Florida
city: Jacksonville
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Ocoee
country: United States
facility: Regeneron Study Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Study Site
state: Florida
city: Woodstock
country: United States
facility: Regeneron Study Site
state: Georgia
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Study Site
state: Illinois
city: Caro
country: United States
facility: Regeneron Study Site
state: Michigan
city: Hartsdale
country: United States
facility: Regeneron Study Site
state: New York
city: Cincinnati
country: United States
facility: Regeneron Study Site
state: Ohio
city: Columbus
country: United States
facility: Regeneron Study Site
state: Ohio
city: Bellaire
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Study Site
state: Texas
city: Wroclaw
country: Poland
facility: Regeneron Study Site
state: Dolnoslaskie
city: Lodz
country: Poland
facility: Regeneron Study Site
state: Lodzkie
city: Warszawa
country: Poland
facility: Regeneron Study Site
state: Mazowieckie
city: Gdansk
country: Poland
facility: Regeneron Study Site
state: Pomorskie
city: Gdynia
country: Poland
facility: Regeneron Study Site
state: Pomorskie
city: Czestochowa
country: Poland
facility: Regeneron Study Site
state: Slaskie
city: Katowice
country: Poland
facility: Regeneron Study Site
state: Slaskie
city: Poznan
country: Poland
facility: Regeneron Study Site
state: Wielkopolskie
city: Lodz
country: Poland
facility: Regeneron Study Site
city: London
country: United Kingdom
facility: Regeneron Study Site
state: Greater London
city: Chorley
country: United Kingdom
facility: Regeneron Study Site
city: Corby
country: United Kingdom
facility: Regeneron Study Site
city: Edgbaston
country: United Kingdom
facility: Regeneron Study Site
city: Glasgow
country: United Kingdom
facility: Regeneron Study Site
city: Hardwick
country: United Kingdom
facility: Regeneron Study Site
city: Hexham
country: United Kingdom
facility: Regeneron Study Site
city: Kenilworth
country: United Kingdom
facility: Regeneron Study Site
city: London
country: United Kingdom
facility: Regulatory Study Site
city: London
country: United Kingdom
facility: Regeneron Study Site
city: London
country: United Kingdom
facility: Regeneron Study Site
city: Manchester
country: United Kingdom
facility: Regeneron Study Site
city: Northwood
country: United Kingdom
facility: Regeneron Study Site
city: Peterborough
country: United Kingdom
facility: Regeneron Study Site
city: Reading
country: United Kingdom
facility: Regeneron Study Site
city: Shipley
country: United Kingdom
facility: Regeneron Study Site
city: Waterloo
country: United Kingdom
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: