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Clinical Trials in the UK / NCT05039619
Recruiting Phase 2

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 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2022-05-12
Last updated
2026-09-03

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

ObinutuzumabPlaceboMycophenolate MofetilAcetaminophen/paracetamolDiphenhydramine hydrochloride (HCl)MethylprednisolonePrednisone

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.

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

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.

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

Diphenhydramine hydrochloride (HCl): Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

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

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.

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

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Loma Linda University health Loma Linda California Recruiting
UCSF Benioff Childrens Hospital San Francisco California Recruiting
Children's Hospital Colorado, Anchutz Medical Campus Aurora Colorado Recruiting
Emory Children's Center Atlanta Georgia Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Louisiana State University Shreveport Louisiana Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Cohen Children's Medical Center of New York Queens New York Recruiting
Cincinnati Childrens Hospital Cincinnati Ohio Recruiting
Chldren?s Hospital of Philadelphia Philadelphia Pennsylvania Withdrawn
Texas Arthritis Center El Paso Texas Withdrawn
Ser Servicos Especializados Em Reumatologia Salvador Estado de Bahia Recruiting
Hospital Universitário Onofre Lopes - UFRN Petrópolis Rio Grande do Norte Recruiting
Centro de Pesquisa São Lucas Campinas São Paulo Recruiting
Hospital das Clinicas - FMUSP São Paulo São Paulo Recruiting
Universidade Federal de Sao Paulo - UNIFES São Paulo Brazil Active Not Recruiting
The Hospital for Sick Children Toronto Ontario Recruiting
Hospital Sainte-Justine Montreal Quebec Recruiting
CH de Bicêtre Le Kremlin-Bicêtre France Recruiting
Hôpital Robert Debré Paris France Recruiting
Hop Necker Enfants Malades Paris France Recruiting
CHU de Toulouse - Hôpital des Enfants Toulouse France Recruiting
Ospedale Pediatrico Bambino Gesu Rome Lazio Recruiting
IRCCS G. Gaslini Genoa Liguria Recruiting
Clinica Pediatrica II De Marchi Milan Lombardy Recruiting
CREA Hospital Mexico Americano Guadalajara Jalisco Recruiting
Clinstile S.A de C.V. Mexico City Mexico CITY (federal District) Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo León Recruiting
Instituto de Ginecología y Reproducción Lima Peru Active Not Recruiting
Clinica El Golf San Isidro Peru Active Not Recruiting
Uniwersyteckie Centrum Kliniczne Gdansk Poland Recruiting
Szpital Specjalistyczny dla Dzieci i Doroslych Torun Poland Withdrawn
Saint-Petersburg State St-peterburg Sankt-Peterburg Withdrawn
Red Cross War Memorial Children?s Hospital Cape Town South Africa Withdrawn
Groote Schuur Hospital Cape Town South Africa Withdrawn
Panaroma Medical Center Panorama South Africa Recruiting
Hospital Sant Joan De Deu Esplugas de Llobregat Barcelona Recruiting
Hospital Ramon y Cajal Madrid Spain Recruiting
Hospital de La Paz Madrid Spain Recruiting
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica Valencia Spain Recruiting

+ 3 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05039619 on ClinicalTrials.gov ↗ ← All trials in the UK