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.
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.
| 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| Chldren?s Hospital of Philadelphia | Philadelphia | Pennsylvania | Withdrawn |
| Texas Arthritis Center | El Paso | Texas | Withdrawn |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 |
| 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.
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