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RECRUITING
NCT05039619
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-05-12

Completion Date

2030-06-14

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Obinutuzumab

Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.

DRUG

Placebo

Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.

DRUG

Acetaminophen/paracetamol

Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.

DRUG

Diphenhydramine hydrochloride (HCl)

Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

DRUG

Methylprednisolone

Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.

DRUG

Prednisone

Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.

Locations (42)

Loma Linda University health

Loma Linda, California, United States

UCSF Benioff Childrens Hospital

San Francisco, California, United States

Children's Hospital Colorado, Anchutz Medical Campus

Aurora, Colorado, United States

Emory Children's Center

Atlanta, Georgia, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Louisiana State University

Shreveport, Louisiana, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Cohen Children's Medical Center of New York

Queens, New York, United States

Cincinnati Childrens Hospital

Cincinnati, Ohio, United States

Chldren?s Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Arthritis Center

El Paso, Texas, United States

Ser Servicos Especializados Em Reumatologia

Salvador, Estado de Bahia, Brazil

Centro de Pesquisa São Lucas

Campinas, São Paulo, Brazil

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

Universidade Federal de Sao Paulo - UNIFES

São Paulo, Brazil

The Hospital for Sick Children

Toronto, Ontario, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

CH de Bicêtre

Le Kremlin-Bicêtre, France

Hôpital Robert Debré

Paris, France

Hop Necker Enfants Malades

Paris, France

CHU de Toulouse - Hôpital des Enfants

Toulouse, France

Ospedale Pediatrico Bambino Gesu

Rome, Lazio, Italy

IRCCS G. Gaslini

Genoa, Liguria, Italy

Clinica Pediatrica II De Marchi

Milan, Lombardy, Italy

CREA Hospital Mexico Americano

Guadalajara, Jalisco, Mexico

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Instituto de Ginecología y Reproducción

Lima, Peru

Clinica El Golf

San Isidro, Peru

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Szpital Specjalistyczny dla Dzieci i Doroslych

Torun, Poland

Saint-Petersburg State

St-peterburg, Sankt-Peterburg, Russia

Red Cross War Memorial Children?s Hospital

Cape Town, South Africa

Groote Schuur Hospital

Cape Town, South Africa

Panaroma Medical Center

Panorama, South Africa

Hospital Sant Joan De Deu

Esplugas de Llobregat, Barcelona, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital de La Paz

Madrid, Spain

Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

Valencia, Spain

Royal Hospital For Children

Glasgow, United Kingdom

Alder Hey Childrens Hospital

Liverpool, United Kingdom

Great Ormond Street Hospital for Children

London, United Kingdom