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

Last updated: March 25, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

Methylprednisolone

Prednisone

Acetaminophen/paracetamol

Clinical Study ID

NCT05039619
WA42985
2023-505825-15-00
2021-000097-29
  • Ages 5-17
  • All Genders

Study 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

Inclusion

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 ofrandomization once recruitment is open. (Investigators will be notified by theSponsor when recruitment is open to this younger population)

  • International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003Class III or IV active LN demonstrated on renal biopsy performed in the 12 monthsprior to or during screening

  • Class V disease may be present in addition to Class III or IV LN, but participantswith 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 havereceived 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 episodeof active LN.

Exclusion

Exclusion Criteria:

  • Severe, active central nervous system (CNS) SLE, including retinitis, poorlycontrolled seizure disorder, acute confusional state, myelitis, stroke, cerebellarataxia, 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 theabsence 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 majorepisode of infection requiring hospitalization or treatment with IV anti-infectivemedications within 4 weeks prior to screening, or completion of oral anti-infectiveswithin 2 weeks prior to randomization

  • History of or currently active primary or secondary immunodeficiency, includingknown 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 ofthe skin that have been excised and cured) within the past 5 years

  • Significant or uncontrolled concomitant medical disease which, in the investigator'sopinion, would preclude participant participation

  • Currently active alcohol or drug abuse or history of alcohol or drug abuse

Study Design

Total Participants: 40
Treatment Group(s): 7
Primary Treatment: Methylprednisolone
Phase: 2
Study Start date:
May 12, 2022
Estimated Completion Date:
September 28, 2029

Connect with a study center

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Bahia 40150-150
    Brazil

    Active - Recruiting

  • Hospital das Clinicas - UNICAMP

    Campinas, SP 13083-888
    Brazil

    Site Not Available

  • Centro de Pesquisa São Lucas

    Campinas, São Paulo 13060-904
    Brazil

    Active - Recruiting

  • Hospital das Clinicas - FMUSP

    Sao Paulo, São Paulo 05403-000
    Brazil

    Active - Recruiting

  • Universidade Federal de Sao Paulo - UNIFES

    Sao Paulo, São Paulo 04038-001
    Brazil

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Hospital Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • Hospital Sainte-Justine; Pediatrics Dept.

    Montreal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • CH de Bicêtre

    Le Kremlin Bicêtre, 94275
    France

    Active - Recruiting

  • CH de Bicêtre; Pediatrie Generale

    Le Kremlin Bicêtre, 94275
    France

    Active - Recruiting

  • Hop Necker Enfants Malades

    Paris, 75743
    France

    Active - Recruiting

  • Hop Necker Enfants Malades;UIH

    Paris, 75743
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • Hôpital Robert Debré; Nephrologie pediatrique

    Paris, 75019
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, 31000
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital des Enfants; Nephro - Rhumato - Medecine Interne - Hypertension

    Toulouse, 31000
    France

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • IRCCS G. Gaslini

    Genova, Liguria 16148
    Italy

    Active - Recruiting

  • IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

    Genova, Liguria 16148
    Italy

    Active - Recruiting

  • Clinica Pediatrica II De Marchi

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • CREA Hospital Mexico Americano

    Guadalajara, Jalisco 44620
    Mexico

    Active - Recruiting

  • CREA Hospital Mexico Americano; Clinica Pediatrica de Reumatologia y Enfermedades Autoinmunes

    Guadalajara, Jalisco 44620
    Mexico

    Site Not Available

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District) 06700
    Mexico

    Active - Recruiting

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo LEON 64460
    Mexico

    Active - Recruiting

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

    Monterrey, Nuevo LEON 64460
    Mexico

    Active - Recruiting

  • Instituto de Ginecología y Reproducción

    Lima,
    Peru

    Active - Recruiting

  • Clinica El Golf

    San Isidro, L27 Lima
    Peru

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-294
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy

    Gdansk, 80-952
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny dla Dzieci i Doroslych

    Torun, 87-100
    Poland

    Site Not Available

  • Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii

    Torun, 87-100
    Poland

    Completed

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji; Klinika Reumatologii Wieku Rozwojowego

    Warszawa, 02-637
    Poland

    Site Not Available

  • FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

    Moscow, Moskovskaja Oblast 115522
    Russian Federation

    Site Not Available

  • Saint-Petersburg State

    St-peterburg, Sankt Petersburg 194100
    Russian Federation

    Site Not Available

  • Saint-Petersburg State; Pediatrics Medical Academy

    St-peterburg, Sankt Petersburg 194100
    Russian Federation

    Site Not Available

  • Saint-Petersburg State; Pediatrics Medical Academy

    Saint-Petersburg, 194100
    Russian Federation

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, 7925
    South Africa

    Site Not Available

  • Groote Schuur Hospital; Renal Unit

    Cape Town, 7925
    South Africa

    Active - Recruiting

  • Red Cross War Memorial Children?s Hospital

    Cape Town, 7700
    South Africa

    Site Not Available

  • Red Cross War Memorial Children?s Hospital; Nephrology Unit

    Cape Town, 7700
    South Africa

    Active - Recruiting

  • Panaroma Medical Center

    Panorama, 7500
    South Africa

    Active - Recruiting

  • Panaroma Medical Center; Clinical Trials Department

    Panorama, 7500
    South Africa

    Site Not Available

  • Hospital Sant Joan De Deu

    Esplugas DE Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

    Esplugas DE Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal ; Servicio de Reumatologia

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital de La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital de La Paz; Unidad de Reumatologia Pediatrica

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

    Valencia, 46026
    Spain

    Active - Recruiting

  • Royal Hospital For Children

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Loma Linda University health

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94117
    United States

    Active - Recruiting

  • Children's Hospital Colorado, Anchutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Emory Children's Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Louisiana State University

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Cohen Children's Medical Center of New York

    Queens, New York 11042
    United States

    Active - Recruiting

  • Cohen Children's Medical Center of New York; Pediatrics

    Queens, New York 11042
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Chldren's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Chldren?s Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Texas Arthritis Center

    El Paso, Texas 79902
    United States

    Active - Recruiting

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