Summary

Eligibility
for people ages 5-17 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)

Keywords

Lupus Nephritis, Nephritis, Acetaminophen, Diphenhydramine, Promethazine, Mycophenolic Acid, Prednisone, Methylprednisolone, Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol, Diphenhydramine hydrochloride (HCl), Open-Label Obinutuzumab

Eligibility

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94117 United States
  • Loma Linda University health accepting new patients
    Loma Linda California 92354 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT05039619
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated