BN42082

• Research type

  Research Study

• Full title

  A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

• IRAS ID

  1003334

• Contact name

  Basil Sharrack

• Contact email

  basil.sharrack@nhs.net

• Sponsor organisation

  F. Hoffman-La Roche

• Eudract number

  2020-000893-69

• Clinicaltrials.gov Identifier

  NCT04544436

• Research summary

  Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, and degenerative
  disease of the Central Nervous System (CNS) that affects approximately 2.3 million
  worldwide. It is primarily a disease of young adults, with 70%−80% of patients having
  an age of onset between 20 and 40 years with approximately up to 64%−70% of
  diagnosed patients being women.
  MS is classified into three clinical phenotypes: relapsing remitting (RRMS), secondary
  progressive (SPMS), and primary progressive (PPMS). SPMS and PPMS are further
  subdivided into active and non-active forms based on the presence or absence of disease
  activity.
  Even though there are many drugs currently available that target the acute inflammatory
  mechanisms associated with relapses and relapse associated worsening, to date, only
  ocrelizumab is indicated for PPMS. As a result, the salient feature of disability
  progression in all forms of MS remains to be further addressed, and treatments that can
  stop or delay MS disease progression represent a serious unmet medical need.
  Ocrelizumab is indicated for use in the relapsing MS (RMS) (i.e., RRMS or SPMS with
  superimposed relapses)and PPMS populations at an approved dose of 600 mg every 6
  months, with demonstrated reduction in disease activity and disability progression. In
  this study a higher dose of ocrelizumab will be tested in the relapsing RMS population.
  In conclusion, it is expected that higher doses of ocrelizumab will provide greater benefit
  for patients in further reducing confirmed disability progression, without compromising
  the safety profile of the drug.
  The study may last up to 7.5 years.
  There will be approximately 28 patients recruited at 7 UK sites
  The study is sponsored by F. Hoffman La Roche

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  20/NW/0339

• Date of REC Opinion

  25 Sep 2020

• REC opinion

  Further Information Favourable Opinion