ALLEGORY - OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

• IRAS ID

  1003808

• Contact name

  Eliza Okoria

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-005760-57

• Clinicaltrials.gov Identifier

  NCT04963296

• Research summary

  SLE is an autoimmune rheumatic disease that occurs primarily in women of childbearing age, characterized by multisystem involvement and immunological abnormalities. The unmet medical need in SLE is high; only one new medication has been approved in more than 50 years.

  Current standard-of-care therapies for SLE include corticosteroids and conventional immunosuppressants which generally have incomplete efficacy for inflammatory manifestations of SLE and their use is frequently limited by toxicities.

  B cells play an active role in the pathogenesis of SLE. Autoreactive B cells recognize and present self-antigens, produce autoantibodies
  and participate in T-cell costimulation. For this reason, they are attractive therapeutic targets in SLE.

  Obinutuzumab (GAZYVA, GAZYVARO) is a recombinant, monoclonal, humanized, and glycoengineered Type II CD20 antibody of the IgG1 isotype that specifically targets the extracellular loop of the CD20 transmembrane antigen that is expressed on the
  surface of non-malignant and malignant pre-B and mature B lymphocytes but not on hematopoietic stem cells, pro-B cells, normal plasma cells, or other normal tissue.

  In light of the clinically meaningful benefits and an acceptable safety profile observed with obinutuzumab in SLE patients with severe LN, the Sponsor is undertaking the present study to assess the efficacy and safety of obinutuzumab, a Type II anti-CD20
  monoclonal antibody with enhanced B-cell depletion, to address a significant unmet medical need in patients with active, autoantibody-positive SLE.

  Approximately 200 patients will be recruited globally with approximately 15 patients recruited at 9 UK sites. The study will last approximately 3 years from first patient screened to last patient last visit.

  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 1 dated 19 February 2021

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0181

• Date of REC Opinion

  15 Sep 2021

• REC opinion

  Further Information Favourable Opinion