Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

NCT03691974 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: R475-OA-17582017-004921-33
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 47

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Peroneal Motor Nerve Conduction Velocity at Week 16

  Peroneal motor nerve conduction velocity was evaluated by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve conduction velocity at Week 16 was reported.

  Baseline, Week 16

• Change From Baseline in Peroneal Motor Nerve Action Potential Amplitude at Week 16

  Peroneal motor nerve action potential amplitude was evaluated at ankle by electrical stimulation of the nerve and recorded the compound muscle action potential from surface electrodes overlying a muscle supplied by the nerve. Change from baseline in peroneal motor nerve action potential amplitude at Week 16 was reported.

  Baseline, Week 16

• Change From Baseline in Sural Sensory Nerve Conduction Velocity at Week 16

  Sural sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve conduction velocity at Week 16 was reported.

  Baseline, Week 16

• Change From Baseline in Sural Sensory Nerve Action Potential Amplitude at Week 16

  Sural sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in sural sensory nerve action potential amplitude at Week 16 was reported.

  Baseline, Week 16

• Change From Baseline in Ulnar Sensory Nerve Conduction Velocity at Week 16

  Ulnar sensory nerve conduction velocity was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline in ulnar sensory nerve conduction velocity at Week 16 was reported.

  Baseline, Week 16

• Change From Baseline in Ulnar Sensory Nerve Action Potential Amplitude at Week 16

  Ulnar sensory nerve action potential amplitude was evaluated by electrically stimulating sensory fibers and recorded the nerve action potential at a point further along that nerve. Change from baseline ulnar sensory nerve action potential amplitude at Week 16 was reported.

  Baseline, Week 16

Secondary Outcomes (11)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

  Baseline, Week 16

• Change From Baseline in WOMAC Physical Function Subscale Score at Week 16

  Baseline, Week 16

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Week 16

• Number of Adjudicated Arthropathy (AA) Events

  Baseline up to follow-up (Week 36)

• Number of AA Events Meeting Destructive Arthropathy (DA) Criteria

  Baseline up to follow-up (Week 36)

Study Arms (2)

Fasinumab

EXPERIMENTAL

Drug: Fasinumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Fasinumab DRUG

Subcutaneous (SC) every four weeks (Q4W)

Also known as: REGN475

Fasinumab

Placebo OTHER

Subcutaneous (SC) every four weeks (Q4W)

Placebo

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 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 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
• 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

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

Sponsors & Collaborators

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

Study Sites (47)

Regeneron Study Site

Glendale, Arizona, 85306, United States

Location

Regeneron Study Site

Glendale, Arizona, 85308, United States

Location

Regeneron Study Site

Phoenix, Arizona, 85053, United States

Location

Regeneron Study Site

Tucson, Arizona, 85412, United States

Location

Regeneron Study Site

Anaheim, California, 92805, United States

Location

Regeneron Study Site

Clearwater, Florida, 33756, United States

Location

Regeneron Study Site

Jacksonville, Florida, 32256, United States

Location

Regeneron Study Site

Miami, Florida, 33165, United States

Location

Regeneron Study Site

Ocoee, Florida, 34761, United States

Location

Regeneron Study Site

Orlando, Florida, 32808, United States

Location

Regeneron Study Site

Woodstock, Georgia, 30189, United States

Location

Regeneron Study Site

Chicago, Illinois, 60607, United States

Location

Regeneron Study Site

Chicago, Illinois, 60611, United States

Location

Regeneron Study Site

Caro, Michigan, 48723, United States

Location

Regeneron Study Site

Hartsdale, New York, 10530, United States

Location

Regeneron Study Site

Cincinnati, Ohio, 45224, United States

Location

Regeneron Study Site

Columbus, Ohio, 43235, United States

Location

Regeneron Study Site

Bellaire, Texas, 77401, United States

Location

Regeneron Study Site

Houston, Texas, 77004, United States

Location

Regeneron Study Site

Houston, Texas, 77058, United States

Location

Regeneron Study Site

San Antonio, Texas, 72858, United States

Location

Regeneron Study Site

Poznan, Greater Poland Voivodeship, 60-702, Poland

Location

Regeneron Study Site

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

Regeneron Study Site

Warsaw, Masovian Voivodeship, 01-192, Poland

Location

Regeneron Study Site

Gdansk, Pomeranian Voivodeship, 80-382, Poland

Location

Regeneron Study Site

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Regeneron Study Site

Częstochowa, Silesian Voivodeship, 42-202, Poland

Location

Regeneron Study Site

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Regeneron Study Site

Lodz, 90-127, Poland

Location

Regeneron Study Site

Lodz, Łódź Voivodeship, 91-211, Poland

Location

Regeneron Study Site

London, Greater London, WC1X8QD, United Kingdom

Location

Regeneron Study Site

Chorley, PR7 7NA, United Kingdom

Location

Regeneron Study Site

Corby, NN172UR, United Kingdom

Location

Regeneron Study Site

Edgbaston, B15 2SQ, United Kingdom

Location

Regeneron Study Site

Glasgow, G20 0SP, United Kingdom

Location

Regeneron Study Site

Hardwick, TS19 8PE, United Kingdom

Location

Regeneron Study Site

Hexham, NE46 1QJ, United Kingdom

Location

Regeneron Study Site

Kenilworth, CV81JD, United Kingdom

Location

Regulatory Study Site

London, DA146LT, United Kingdom

Location

Regeneron Study Site

London, RG401XS, United Kingdom

Location

Regeneron Study Site

London, RM13PJ, United Kingdom

Location

Regeneron Study Site

Manchester, M15 6SX, United Kingdom

Location

Regeneron Study Site

Northwood, HA62RN, United Kingdom

Location

Regeneron Study Site

Peterborough, PE73JL, United Kingdom

Location

Regeneron Study Site

Reading, RG2 0TG, United Kingdom

Location

Regeneron Study Site

Shipley, BD183SL, United Kingdom

Location

Regeneron Study Site

Waterloo, L22 0LG, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

fasinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 2, 2018
• Study Start: October 15, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 7, 2021
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Locations

US (21); PL (9); GB (17)