2상모집 중
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
연구 개요
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.
- 스폰서
- 리드: 로슈
- 적응증
- Lupus Nephritis
- 중재
- Obinutuzumab, Placebo, Mycophenolate Mofetil, Acetaminophen/paracetamol, Diphenhydramine hydrochloride (HCl), Methylprednisolone, Prednisone
- 목표 등록
- 40명
- 시작일
- 2022-05-12
- 완료(예정)
- 2030-06-14
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