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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) — Week 76
CRR is defined as achievement of all of the following: * Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g * Estimated Glomerular Filtration Rate (eGFR) \>=85% of baseline * No occurrence of intercurrent events - Percentage of Participants with Adverse Events (PP) — Baseline to Week 76
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Instituto de Ensino da Saude e Gestao - IESG | Salvado | 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 |
+ 4 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
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 Poland