Fasinumab

Generic Name: Fasinumab

Drug Type: Biotech

CAS Number: 1190239-42-9

Unique Ingredient Identifier: 11T51Q3082

Background: Fasinumab is a human IgG1k monoclonal antibody targeted against nerve growth factor (NGF). It is currently under investigation for the treatment osteoarthritic pain and has demonstrated significantly greater pain relief and functional improvement as compared to standard therapy (i.e. NSAIDs and/or opioids) in this patient population.

NGF was first discovered in the 1950s and was the first neurotrophic factor to be identified and biochemically characterized. It has since been recognized for its role in nociceptive signaling transduction and has thus become an attractive target in the treatment of chronic pain conditions.

Clinical Trials

Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip

Phase 2

Terminated

Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee

Interventions: Drug: Fasinumab
Drug: Naproxen
Drug: Diclofenac
Drug: Celecoxib
Drug: Placebo

First Posted Date: 2019-05-14

Last Posted Date: 2023-10-17

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 23

Registration Number: NCT03949673

Locations: 🇵🇱
Regeneron Recruting SIte, Bialystok, Poland
🇬🇧
Regeneron Research Site, Liverpool, United Kingdom

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

Phase 2

Completed

Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee

Interventions: Drug: Fasinumab
Other: Placebo

First Posted Date: 2018-10-02

Last Posted Date: 2023-03-01

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 180

Registration Number: NCT03691974

Locations: 🇬🇧
Regulatory Study Site, London, United Kingdom
🇬🇧
Regeneron Study Site, Waterloo, United Kingdom

To Assess the Patients' Ability to Self-Administer Fasinumab

Phase 1

Completed

Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee

Interventions: Drug: Fasinumab AI
Drug: Fasinumab PFS

First Posted Date: 2018-04-09

Last Posted Date: 2021-03-03

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 100

Registration Number: NCT03491904

Locations: 🇺🇸
Regeneron Research Facility, Houston, Texas, United States

Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

Phase 3

Completed

Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip

Interventions: Other: Diclofenac
Other: Celecoxib
Drug: Fasinumab
Drug: Matching placebo

First Posted Date: 2017-10-09

Last Posted Date: 2023-02-24

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 1650

Registration Number: NCT03304379

Locations: 🇺🇸
Advance Research Center, Anaheim, California, United States
🇺🇸
Catalina Research Institute, LLC, Montclair, California, United States
🇺🇸
Clinical Research Advantage, Inc./Warner Family Practice, PC, Chandler, Arizona, United States

and more 66 locations

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Phase 3

Terminated

Conditions: Chronic Low Back Pain
Osteoarthritis

Interventions: Drug: Placebo
Drug: Fasinumab

First Posted Date: 2017-09-18

Last Posted Date: 2021-06-30

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 63

Registration Number: NCT03285646

Locations: 🇺🇸
Regeneron Research Site #1, Memphis, Tennessee, United States
🇺🇸
Regeneron Research Site, Kenosha, Wisconsin, United States
🇺🇸
Regeneron Research Site #2, Memphis, Tennessee, United States

Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

Phase 2

Completed

Conditions: Osteoarthritis, Knee / Osteoarthritis, Hip

Interventions: Drug: MT-5547
Drug: MT-5547-matching placebo

First Posted Date: 2017-08-10

Last Posted Date: 2023-05-17

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Target Recruit Count: 626

Registration Number: NCT03245008

Locations: 🇯🇵
Investigational Site, Yamaguchi, Japan

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

Phase 3

Completed

Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip

Interventions: Drug: Fasinumab
Drug: Fasinumab-matching placebo
Drug: Naproxen
Drug: Naproxen-matching placebo

First Posted Date: 2017-05-19

Last Posted Date: 2022-11-14

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 3307

Registration Number: NCT03161093

Locations: 🇺🇸
Pacific Arthritis Care Center, Los Angeles, California, United States
🇺🇸
Lynn Institute of the Rockies, Colorado Springs, Colorado, United States
🇺🇸
Panorama Orthopedics & Spine Center, Golden, Colorado, United States

and more 129 locations

Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

Phase 3

Completed

Conditions: Osteoarthritis of the Knee or Hip

Interventions: Drug: Fasinumab
Drug: Placebo

First Posted Date: 2016-02-17

Last Posted Date: 2023-10-13

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 5331

Registration Number: NCT02683239

Locations: 🇺🇸
Regeneron Investigational Site (4 locations), Phoenix, Arizona, United States
🇬🇧
Regeneron Investigational Site, Sidcup, United Kingdom
🇺🇦
Regeneron Investigational Site #1, Kyiv, Ukraine

and more 5 locations