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NCT05039619PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

5/12/2022

Completion Date

6/14/2030

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.

Eligibility Criteria

Age Range: 5 years to 17 years

Inclusion Criteria: * Participants who are age 12 to \<18 years at the time of randomization * Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population) * International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening * Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible * Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria * Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening * During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN. Exclusion Criteria: * Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia * Sclerosis in \>50% of glomeruli on renal biopsy * Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions * Presence of rapidly progressive glomerulonephritis * Pure Class V LN * Intolerance or contraindication to study therapies * Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization * History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders * History of serious recurrent or chronic infection * History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years * Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation * Currently active alcohol or drug abuse or history of alcohol or drug abuse

Interventions

DRUG

Obinutuzumab

DRUG

Placebo

DRUG

Mycophenolate Mofetil

DRUG

Acetaminophen/paracetamol

DRUG

Diphenhydramine hydrochloride (HCl)

DRUG

Methylprednisolone

DRUG

Prednisone

Interested in This Trial?

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Conditions

Lupus Nephritis

Locations

Loma Linda University health

Loma Linda, California 92354

United States

UCSF Benioff Childrens Hospital

San Francisco, California 94158

United States

Children's Hospital Colorado, Anchutz Medical Campus

Aurora, Colorado 80045

United States

Emory Children's Center

Atlanta, Georgia 30322

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

Louisiana State University

Shreveport, Louisiana 71103

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Cohen Children's Medical Center of New York

Queens, New York 11042

United States

Cincinnati Childrens Hospital

Cincinnati, Ohio 45229

United States

Chldren?s Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Texas Arthritis Center

El Paso, Texas 79902

United States

Ser Servicos Especializados Em Reumatologia

Salvador, Estado de Bahia 40150-150

Brazil

Centro de Pesquisa São Lucas

Campinas, São Paulo 13060-904

Brazil

Hospital das Clinicas - FMUSP

São Paulo, São Paulo 05403-000

Brazil

Universidade Federal de Sao Paulo - UNIFES

São Paulo, 04024-002

Brazil

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

Hospital Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

CH de Bicêtre

Le Kremlin-Bicêtre, 94275

France

Hôpital Robert Debré

Paris, 75019

France

Hop Necker Enfants Malades

Paris, 75743

France

CHU de Toulouse - Hôpital des Enfants

Toulouse, 31000

France

Ospedale Pediatrico Bambino Gesu

Rome, Lazio 00165

Italy

IRCCS G. Gaslini

Genoa, Liguria 16148

Italy

Clinica Pediatrica II De Marchi

Milan, Lombardy 20122

Italy

CREA Hospital Mexico Americano

Guadalajara, Jalisco 44620

Mexico

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District) 06700

Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León 64460

Mexico

Instituto de Ginecología y Reproducción

Lima,

Peru

Clinica El Golf

San Isidro, L27 Lima

Peru

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-294

Poland

Szpital Specjalistyczny dla Dzieci i Doroslych

Torun, 87-100

Poland

Saint-Petersburg State

St-peterburg, Sankt-Peterburg 194100

Russia

Red Cross War Memorial Children?s Hospital

Cape Town, 7700

South Africa

Groote Schuur Hospital

Cape Town, 7925

South Africa

Panaroma Medical Center

Panorama, 7500

South Africa

Hospital Sant Joan De Deu

Esplugas de Llobregat, Barcelona 08950

Spain

Hospital Ramon y Cajal

Madrid, 28034

Spain

Hospital de La Paz

Madrid, 28046

Spain

Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

Valencia, 46026

Spain

Royal Hospital For Children

Glasgow, G51 4TF

United Kingdom

Alder Hey Childrens Hospital

Liverpool, L12 2AP

United Kingdom

Great Ormond Street Hospital for Children

London, WC1N 3JH

United Kingdom