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

Phase 2 Recruiting 40 enrolled Hoffmann-La Roche Genentech, Inc. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2022-05-12
Primary completion: 2028-06-15
Completion: 2030-06-14

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obinutuzumab	Monoclonal antibody	20 mg/kg	Intravenous
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	Intravenous
Background	Acetaminophen	Small molecule	1000 mg	—
Background	Diphenhydramine	Unknown	50 mg	—
Background	Methylprednisolone	Other / unclassified	80 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1200 mg/m2	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications