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
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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.

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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

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

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