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
Recruiting · NCT05039619 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
Acetaminophen/paracetamolDiphenhydramine hydrochloride (HCl)MethylprednisoloneMycophenolate MofetilObinutuzumabPlaceboPrednisone
What this trial is about
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.
Who can take part
Age range
5 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
43 locations listed across 10 US states.
- 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
- Red Cross War Memorial Children?s Hospital - Cape Town, South Africa
- Groote Schuur Hospital - Cape Town, South Africa
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Royal Hospital For Children - Glasgow, United Kingdom
- CH de Bicêtre - Le Kremlin-Bicêtre, France
- Instituto de Ginecología y Reproducción - Lima, Peru
- Alder Hey Childrens Hospital - Liverpool, United Kingdom
- Great Ormond Street Hospital for Children - London, United Kingdom
- Hospital Ramon y Cajal - Madrid, Spain
- Hospital de La Paz - Madrid, Spain
- Panaroma Medical Center - Panorama, South Africa
- Hôpital Robert Debré - Paris, France
- Hop Necker Enfants Malades - Paris, France
- Clinica El Golf - San Isidro, Peru
- Universidade Federal de Sao Paulo - UNIFES - São Paulo, Brazil
- Szpital Specjalistyczny dla Dzieci i Doroslych - Torun, Poland
- CHU de Toulouse - Hôpital des Enfants - Toulouse, France
- Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica - Valencia, Spain
- Hospital Sant Joan De Deu - Esplugas de Llobregat, Barcelona, Spain
- Ser Servicos Especializados Em Reumatologia - Salvador, Estado de Bahia, Brazil
- CREA Hospital Mexico Americano - Guadalajara, Jalisco, Mexico
- Ospedale Pediatrico Bambino Gesu - Rome, Lazio, Italy
- IRCCS G. Gaslini - Genoa, Liguria, Italy
- Clinica Pediatrica II De Marchi - Milan, Lombardy, Italy
- Clinstile S.A de C.V. - Mexico City, Mexico CITY (federal District), Mexico
- Hospital Universitario Dr. Jose Eleuterio Gonzalez - Monterrey, Nuevo León, Mexico
- The Hospital for Sick Children - Toronto, Ontario, Canada
- Hospital Sainte-Justine - Montreal, Quebec, Canada
- Hospital Universitário Onofre Lopes - UFRN - Petrópolis, Rio Grande do Norte, Brazil
- Saint-Petersburg State - St-peterburg, Sankt-Peterburg, Russia
- Centro de Pesquisa São Lucas - Campinas, São Paulo, Brazil
- Hospital das Clinicas - FMUSP - São Paulo, São Paulo, Brazil