Obinutuzumab for Lupus Nephritis in Teens

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 Phase 2 Interventional Study
Lupus Nephritis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
5 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for teenagers aged 12 to 18 and children aged 5 to under 12 who have been diagnosed with lupus nephritis. Participants will receive treatment with obinutuzumab and be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am aged 12 to under 18 years
  • I am aged 5 to under 12 years
  • I have been diagnosed with lupus nephritis confirmed by kidney biopsy
  • I have a diagnosis of systemic lupus erythematosus (SLE)
  • I have significant protein in my urine
  • I have received at least one dose of pulse-range IV methylprednisolone for my lupus nephritis

You may not be able to join if

  • I have severe central nervous system lupus
  • I have more than 50% scarring in my kidneys
  • I have chronic lupus nephritis without active lesions
  • I have pure Class V lupus nephritis
  • I have had any active infection in the last 4 weeks
  • I have a history of serious immune system issues
  • I have had cancer in the past 5 years
  • I currently abuse alcohol or drugs

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants who are age 12 to \<18 years at the time of randomization * Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this…
Contacts

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global.rochegenentechtrials@roche.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT