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Be Part of Research - Trial Details - A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Not Recruiting

Open to: ALL

Age: 18.0 - 75.0

Manchester London Cambridge London Leeds

Medical Conditions

Lupus Erythematosus, Systemic

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2021 Sep 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.

Intervention Arm Group : Obinutuzumab;

Intervention Type : DRUG
Intervention Description : Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

Intervention Arm Group : Obinutuzumab;Placebo;

Intervention Type : DRUG
Intervention Description : Diphenhydramine 50 mg will be administered as premedication prior to infusions.

Intervention Arm Group : Obinutuzumab;Placebo;

Intervention Type : DRUG
Intervention Description : Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Intervention Arm Group : Obinutuzumab;Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Manchester Royal Infirmary
    Manchester
    M13 9WL
  • Royal Free Hospital
    London
    NW3 2QG
  • Addenbrooke'S Hospital
    Cambridge
    CB2 2QQ
  • Guy's Hospital
    London
    SE1 9RT
  • Chapel Allerton Hospital
    Leeds
    LS1 3EX


The study is sponsored by Hoffmann-La Roche



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Read full details for Trial ID: NCT04963296
Last updated 11 April 2025

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