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Contact Information:

Reference Study ID Number: WA42985 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada)
global.rochegenentechtrials@roche.com


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Be Part of Research - Trial Details - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

Recruiting

Open to: ALL

Age: 5.0 - 17.0

London Liverpool Glasgow

Medical Conditions

Lupus Nephritis

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 phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.

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:

May 2022 Aug 2027

Publications

"Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6."; "37678236"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.

Intervention Arm Group : Blinded Obinutuzumab;Open-Label Obinutuzumab;

Intervention Type : DRUG
Intervention Description : Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.

Intervention Arm Group : Placebo;

Intervention Type : DRUG
Intervention Description : Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.

Intervention Arm Group : Blinded Obinutuzumab;Open-Label Obinutuzumab;Placebo;

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

Intervention Arm Group : Blinded Obinutuzumab;Open-Label Obinutuzumab;Placebo;

Intervention Type : DRUG
Intervention Description : Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

Intervention Arm Group : Blinded Obinutuzumab;Open-Label Obinutuzumab;Placebo;

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

Intervention Arm Group : Blinded Obinutuzumab;Open-Label Obinutuzumab;Placebo;

Intervention Type : DRUG
Intervention Description : Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.

Intervention Arm Group : Blinded Obinutuzumab;Open-Label 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.

  • Great Ormond Street Hospital for Children
    London
    WC1N 3JH
  • Alder Hey Childrens Hospital
    Liverpool
    L12 2AP
  • Royal Hospital For Children
    Glasgow
    G51 4TF

Reference Study ID Number: WA42985 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada)
global.rochegenentechtrials@roche.com



The study is sponsored by Hoffmann-La Roche and is in collaboration with Genentech, Inc..



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Read full details for Trial ID: NCT05039619
Last updated 04 December 2025

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