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.
Lupus Nephritis
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.
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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Loma Linda University health, Loma Linda, California, United States, 92354
University of California San Francisco, San Francisco, California, United States, 94117
Children's Hospital Colorado, Anchutz Medical Campus, Aurora, Colorado, United States, 80045
Emory Children's Center, Atlanta, Georgia, United States, 20010
Indiana University Health University Hospital, Indianapolis, Indiana, United States, 46202
Louisiana State University, Shreveport, Louisiana, United States, 71103
Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601
Cohen Children's Medical Center of New York; Pediatrics, Queens, New York, United States, 11042
Cincinnati Childrens Hospital, Cincinnati, Ohio, United States, 45229
Chldren?s Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
5 Years to 17 Years
ALL
No
Hoffmann-La Roche,
Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche
2029-03-13