A clinical trial to look at how well obinutuzumab works to reduce certain features of systemic lupus erythematosus (SLE) when compared to placebo

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

  • Systemic Lupus Erythematosus
Trial Status:

Recruiting

This trial runs in
Cities
  • Amarillo
  • Atlanta
  • Auckland
  • Barcelona
  • Berea
  • Bilbo
  • Birmingham
  • Brescia
  • Brest
  • Buenos Aires
  • Bydgoszcz
  • Cambridge
  • Cape Town
  • Chatsworth
  • Ciudad de México
  • Culiacán Rosales
  • Denver
  • Fullerton
  • gqeberha
  • Great Neck
  • Houston
  • karwiany
  • Liverpool
  • Lombardy
  • London
  • Madrid
  • Mexicali
  • Minas Gerais
  • Monterrey
  • Moscow
  • Moskva
  • Orlando
  • Paris
  • Pisa
  • Poznań
  • Pretoria
  • Rennes
  • republic-of-tatarstan
  • Roma
  • Saint Petersburg
  • San Miguel de Tucumán
  • san-juan-de-lurigancho
  • Sankt-Peterburg
  • Santiago de Compostela
  • Santiago de Surco
  • Stellenbosch
  • Torreón
  • Trujillo
  • Ufa
  • Vigo
  • Warszawa
  • Wellington
  • yaroslavl-
  • Yekaterinburg
Trial Identifier:

NCT04963296 2020-005760-57 CA42750

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04963296 , CA42750 , 2020-005760-57 Trial Identifier
      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers

      How does the ALLEGORY clinical trial work?

      This clinical trial is recruiting people who have a type of disease called systemic lupus erythematosus (SLE). In order to take part, patients must have a diagnosis of SLE according to certain criteria. 

      The purpose of this clinical trial is to compare the effects, good or bad, of obinutuzumab against placebo in patients with SLE. If you take part in this clinical trial, you will receive either obinutuzumab or placebo in addition to your standard SLE medications. 

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be between 18 and 75 years old, and have been diagnosed with SLE according to certain criteria, such as high disease activity. You must be receiving at least one standard treatment for your disease, such as oral corticosteroids, immunosuppressants or antimalarials.

      You must not be pregnant or breastfeeding, or intend to become pregnant or breastfeed, during the clinical trial or within 18 months after your final dose of clinical trial treatment. You may also not be able to take part in this clinical trial if you have previously received certain other medications or have certain other medical conditions. 

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

      While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?

      Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:

      • Obinutuzumab, as an infusion (into the vein) on Day 1 and Weeks 2, 24 and 26
      • OR placebo, as an infusion (into the vein) on Day 1 and Weeks 2, 24 and 26.

      You will have a 1 in 2 (50%) chance of being placed in either group. Both groups will receive an infusion of steroids, as well as doses of antihistamine and paracetamol/acetaminophen, prior to each obinutuzumab or placebo infusion. 

      If you join this clinical trial, you will be able to continue taking your standard SLE therapy as guided by your clinical trial doctor.

      This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given medicine with no active ingredients (also known as a ‘placebo’). A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial.

      Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk. 

      After Week 52 of the clinical trial, you may be eligible to continue treatment with obinutuzumab, regardless of whether you were previously receiving obinutuzumab or placebo. This is the open-label phase of the clinical trial and both you and your clinical trial doctor will know which treatment you are receiving. 

      How often will I be seen in follow-up appointments and for how long?

      You will be given the clinical trial treatment, either obinutuzumab or placebo, four times over a period of six months in the first part of the trial, which will last for 12 months in total. You will be seen roughly every month by your clinical trial doctor during this period so they can see how you are responding to treatment and any side effects you may be having. You are free to stop this treatment at any time.

      If you then join the open-label phase of the clinical trial, you will receive obinutuzumab four more times over the course of an additional six months, before entering a follow-up period after a total of 12 months.

      After your last dose of treatment, you will still be seen regularly by the clinical trial doctor. The first follow-up visit will be roughly six months after your last visit and you will continue to be seen every six months to check whether certain immune cells in your blood have returned to normal levels after stopping treatment.

      What happens if I am unable to take part in this clinical trial?

      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04963296

      Trial-identifier: NCT04963296

      Trial Summary

      This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04963296 , CA42750 , 2020-005760-57 Trial Identifier
      Obinutuzumab, Placebo, Acetaminophen/Paracetamol, Diphenhydramine hydrochloride, Methylprednisolone Treatments
      Systemic Lupus Erythematosus Condition
      Official 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

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 75 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria >=12 weeks prior to screening
      • Anti-nuclear antibody (ANA) >=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
      • Low C3 and/or low C4 and/or low CH50 complement as determined by the central laboratory at screening
      • High disease activity at screening, based on; BILAG-2004 (Category A disease in >=1 organ system and/or Category B disease in >=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score >=8) and Physician's Global Assessment (PGA) (score >=1.0 on a 0 to 3 visual analogue scale [VAS])
      • High disease activity on Day 1, based on; SLEDAI-2K (score >=8) and PGA (score >=1.0 on a 0 to 3 VAS)
      • Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
      • Other inclusion criteria may apply
      Exclusion Criteria
      • Pregnancy or breastfeeding
      • Presence of significant lupus-associated renal disease and/or renal impairment
      • Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
      • Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
      • Known active infection of any kind or recent major episode of infection
      • Intolerance or contraindication to study therapies
      • Other exclusion criteria may apply

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