CA41705 THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH LUPUS NEPHRITIS

• 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 ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS

• IRAS ID

  1003261

• Contact name

  Michael Robson

• Eudract number

  2019-004034-42

• Research summary

  Systemic lupus erythematosus (SLE) is an autoimmune rheumatic disease that occurs
  primarily in women of childbearing age.
  Lupus nephritis (LN) is the most common organ-threatening manifestation of SLE and a
  major cause of morbidity and mortality.
  Current standard-of-care therapy for patients with proliferative LN includes use of
  corticosteroids in combination with either MMF or cyclophosphamide, however only a
  minority of patients achieve a complete response within the first 1-2 years, and the rate of
  progression to end stage renal disease has not decreased in recent decades. These
  standard-of-care therapies are also associated with substantial toxicities that contribute
  to the morbidity associated with LN.
  Given the seriousness of this condition, the limited efficacy of current standard of care,
  and the toxicities associated with current standard of care, there remains a high need for
  further research. The efficacy of obinutuzumab in patients with LN has been studied in a
  Phase II, double-blinded, randomized, placebo controlled study (NOBILITY). Nobility
  met its primary and key secondary efficacy Endpoints and obinutuzumab demonstrated
  rapid and complete peripheral B-cell depletion in LN patients and was associated with a
  clinically
  meaningful benefit on the achievement of complete renal response (CRR).
  This study will further evaluate the efficacy, safety, and pharmacokinetics of
  obinutuzumab compared with placebo in patients with International Society of
  Nephrology/Renal Pathology Society (ISN/RPS) Class III or IV lupus nephritis (LN)
  when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF)
  and corticosteroids.
  250 patients will be recruited globally with approximately 12 patients recruited at 6 UK
  sites. The study will last approximately 1.5 - 2 years from first patient screened to last
  patient last visit.
  The study is sponsored by F. Hoffman La Roche

• REC name

  HSC REC A

• REC reference

  20/NI/0086

• Date of REC Opinion

  26 Aug 2020

• REC opinion

  Further Information Favourable Opinion