Effects of Fasinumab on Peripheral Nerve Function in OA pain

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    245856

  • Contact name

    Nicholas Probert

  • Contact email

    nick.probert@synexus.com

  • Sponsor organisation

    Regeneron Pharmaceuticals, Inc.

  • Eudract number

    2017-004921-33

  • ISRCTN Number

    ISRCTN00000000

  • Clinicaltrials.gov Identifier

    NCT00000000

  • Clinicaltrials.gov Identifier

    103245, IND: Number

  • Duration of Study in the UK

    2 years, 1 months, 10 days

  • Research summary

    Fasinumab is currently being studied for treatment of pain due to Osteoarthritis (OA) of the hip or knee and chronic low back pain (CLBP). Fasinumab is a fully-human monoclonal antibody (a type of protein) that blocks a substance called nerve growth factor (NGF); also called an anti-NGF drug. NGF is a protein that causes pain. Blocking NGF may reduce pain due to OA of the hip and knee.

    The main purpose of this study is to determine the effect of fasinumab compared to placebo (an inactive drug) on peripheral nerves in participants with pain due to OA of hip or knee.

    The study includes screening, pre-randomisation (before being assigned to study drug or placebo), Treatment period and follow-up period. Participation in study may last up to 64 weeks excluding initial 40 days of screening and pre-randomisation period. Participants will be required to make at least 10 visits to the study site, and answer 2 phone calls from the study team.

    This study will include about 180 participants in approximately 65 sites in North America, Europe and South Africa.

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    18/NW/0683

  • Date of REC Opinion

    17 Oct 2018

  • REC opinion

    Favourable Opinion