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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

NCT05039619 · Hoffmann-La Roche
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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)
About this study
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 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
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2022-05-12
Estimated completion: 2030-06-14
Last updated: 2026-04-03
Interventions
Drug: ObinutuzumabDrug: PlaceboDrug: Mycophenolate MofetilDrug: Acetaminophen/paracetamolDrug: Diphenhydramine hydrochloride (HCl)Drug: MethylprednisoloneDrug: Prednisone
Primary outcomes
  • Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) (Week 76)
  • Percentage of Participants with Adverse Events (PP) (Baseline to Week 76)
Sponsor
Hoffmann-La Roche · industry
With: Genentech, Inc.
Contacts & investigators
ContactReference Study ID Number: WA42985 https://forpatients.roche.com/ · contact · global.rochegenentechtrials@roche.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (42)
Loma Linda University healthRecruiting
Loma Linda, California, United States
UCSF Benioff Childrens HospitalRecruiting
San Francisco, California, United States
Children's Hospital Colorado, Anchutz Medical CampusRecruiting
Aurora, Colorado, United States
Emory Children's CenterRecruiting
Atlanta, Georgia, United States
Indiana University Health University HospitalRecruiting
Indianapolis, Indiana, United States
Louisiana State UniversityRecruiting
Shreveport, Louisiana, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Cohen Children's Medical Center of New YorkRecruiting
Queens, New York, United States
Cincinnati Childrens HospitalRecruiting
Cincinnati, Ohio, United States
Chldren?s Hospital of PhiladelphiaWithdrawn
Philadelphia, Pennsylvania, United States
Texas Arthritis CenterWithdrawn
El Paso, Texas, United States
Ser Servicos Especializados Em ReumatologiaRecruiting
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa São LucasRecruiting
Campinas, São Paulo, Brazil
Hospital das Clinicas - FMUSPRecruiting
São Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESActive Not Recruiting
São Paulo, Brazil
The Hospital for Sick ChildrenRecruiting
Toronto, Ontario, Canada
Hospital Sainte-JustineRecruiting
Montreal, Quebec, Canada
CH de BicêtreRecruiting
Le Kremlin-Bicêtre, France
Hôpital Robert DebréRecruiting
Paris, France
Hop Necker Enfants MaladesRecruiting
Paris, France
CHU de Toulouse - Hôpital des EnfantsRecruiting
Toulouse, France
Ospedale Pediatrico Bambino GesuRecruiting
Rome, Lazio, Italy
IRCCS G. GasliniRecruiting
Genoa, Liguria, Italy
Clinica Pediatrica II De MarchiRecruiting
Milan, Lombardy, Italy
CREA Hospital Mexico AmericanoRecruiting
Guadalajara, Jalisco, Mexico
Clinstile S.A de C.V.Recruiting
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario Dr. Jose Eleuterio GonzalezRecruiting
Monterrey, Nuevo León, Mexico
Instituto de Ginecología y ReproducciónActive Not Recruiting
Lima, Peru
Clinica El GolfActive Not Recruiting
San Isidro, Peru
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Szpital Specjalistyczny dla Dzieci i DoroslychWithdrawn
Torun, Poland
Saint-Petersburg StateWithdrawn
St-peterburg, Sankt-Peterburg, Russia
Red Cross War Memorial Children?s HospitalWithdrawn
Cape Town, South Africa
Groote Schuur HospitalWithdrawn
Cape Town, South Africa
Panaroma Medical CenterRecruiting
Panorama, South Africa
Hospital Sant Joan De DeuRecruiting
Esplugas de Llobregat, Barcelona, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Hospital de La PazRecruiting
Madrid, Spain
Hospital Universitario la Fe: Servicio de Reumatologia PediatricaRecruiting
Valencia, Spain
Royal Hospital For ChildrenWithdrawn
Glasgow, United Kingdom
Alder Hey Childrens HospitalRecruiting
Liverpool, United Kingdom
Great Ormond Street Hospital for ChildrenRecruiting
London, United Kingdom
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 · TrialPath