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)
Who is this study for? Adolescents with active class III or IV lupus nephritis
What treatments are being studied? Obinutuzumab
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Loma Linda University health
RECRUITING
Loma Linda
UCSF Benioff Childrens Hospital
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado, Anchutz Medical Campus
RECRUITING
Aurora
Georgia
Emory Children's Center
RECRUITING
Atlanta
Indiana
Indiana University Health University Hospital
RECRUITING
Indianapolis
Louisiana
Louisiana State University
RECRUITING
Shreveport
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Cohen Children's Medical Center of New York
RECRUITING
Queens
Ohio
Cincinnati Childrens Hospital
RECRUITING
Cincinnati
Pennsylvania
Chldren?s Hospital of Philadelphia
WITHDRAWN
Philadelphia
Texas
Texas Arthritis Center
WITHDRAWN
El Paso
Other Locations
Brazil
Centro de Pesquisa São Lucas
RECRUITING
Campinas
Ser Servicos Especializados Em Reumatologia
RECRUITING
Salvador
Hospital das Clinicas - FMUSP
RECRUITING
São Paulo
Universidade Federal de Sao Paulo - UNIFES
ACTIVE_NOT_RECRUITING
São Paulo
Canada
Hospital Sainte-Justine
RECRUITING
Montreal
The Hospital for Sick Children
RECRUITING
Toronto
France
CH de Bicêtre
RECRUITING
Le Kremlin-bicêtre
Hop Necker Enfants Malades
RECRUITING
Paris
Hôpital Robert Debré
RECRUITING
Paris
CHU de Toulouse - Hôpital des Enfants
RECRUITING
Toulouse
Italy
IRCCS G. Gaslini
RECRUITING
Genoa
Clinica Pediatrica II De Marchi
RECRUITING
Milan
Ospedale Pediatrico Bambino Gesu
RECRUITING
Rome
Mexico
CREA Hospital Mexico Americano
RECRUITING
Guadalajara
Clinstile S.A de C.V.
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Peru
Instituto de Ginecología y Reproducción
ACTIVE_NOT_RECRUITING
Lima
Clinica El Golf
ACTIVE_NOT_RECRUITING
San Isidro
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Szpital Specjalistyczny dla Dzieci i Doroslych
WITHDRAWN
Torun
Russian Federation
Saint-Petersburg State
WITHDRAWN
St-peterburg
South Africa
Groote Schuur Hospital
WITHDRAWN
Cape Town
Red Cross War Memorial Children?s Hospital
WITHDRAWN
Cape Town
Panaroma Medical Center
RECRUITING
Panorama
Spain
Hospital Sant Joan De Deu
RECRUITING
Esplugas De Llobregat
Hospital de La Paz
RECRUITING
Madrid
Hospital Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
RECRUITING
Valencia
United Kingdom
Royal Hospital For Children
WITHDRAWN
Glasgow
Alder Hey Childrens Hospital
RECRUITING
Liverpool
Great Ormond Street Hospital for Children
RECRUITING
London
Contact Information
Primary
Reference Study ID Number: WA42985 https://forpatients.roche.com/
global.rochegenentechtrials@roche.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date:2022-05-12
Estimated Completion Date:2029-09-28
Participants
Target number of participants:40
Treatments
Experimental: Blinded Obinutuzumab
Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusions on Day 1, Day 14, Week 24, Week 26 and Week 52. Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg).
Placebo_comparator: Placebo
Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.
Experimental: Open-Label Obinutuzumab
Younger participants aged 5 to \<12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.