Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-04
40
Participants Needed
42
Research Sites
422 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to less than 18 years at randomization
- Age 5 to less than 12 years at randomization once recruitment opens for this group
- Biopsy-confirmed active Class III or IV lupus nephritis within 12 months prior to or during screening
- Class V lupus nephritis may be present alongside Class III or IV, but isolated Class V is not allowed
- Diagnosis of systemic lupus erythematosus (SLE) according to SLICC 2012 criteria
- Significant proteinuria defined as urine protein-to-creatinine ratio above 0.5 from first morning void at screening
- Received at least one dose of pulse-range IV methylprednisolone or equivalent within 12 months prior to or during screening for current lupus nephritis episode
You will not qualify if you...
- Severe, active central nervous system lupus including retinitis, poorly controlled seizures, acute confusion, myelitis, stroke, cerebellar ataxia, or dementia
- Sclerosis in more than 50% of kidney glomeruli on biopsy
- Purely chronic Class III(c) or Class IV(c) lupus nephritis without active lesions
- Presence of rapidly progressive glomerulonephritis
- Pure Class V lupus nephritis
- Intolerance or contraindication to study treatments
- Active infection of any kind (except nail bed fungal infection) or recent major infection requiring hospitalization or IV treatment within 4 weeks prior to screening, or completion of oral anti-infective treatment within 2 weeks prior to randomization
- History or current primary or secondary immunodeficiency including known HIV or severe immunodeficiency blood disorders
- History of serious recurrent or chronic infection
- History or current cancer within past 5 years (except excised basal or squamous cell skin carcinoma)
- Significant or uncontrolled medical conditions that would prevent study participation
- Current active alcohol or drug abuse or history of such abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Loma Linda University health
Loma Linda, California, United States, 92354
Actively Recruiting
2
UCSF Benioff Childrens Hospital
San Francisco, California, United States, 94158
Actively Recruiting
3
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Emory Children's Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Louisiana State University
Shreveport, Louisiana, United States, 71103
Actively Recruiting
7
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Cohen Children's Medical Center of New York
Queens, New York, United States, 11042
Actively Recruiting
9
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Chldren?s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
11
Texas Arthritis Center
El Paso, Texas, United States, 79902
Withdrawn
12
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil, 40150-150
Actively Recruiting
13
Centro de Pesquisa São Lucas
Campinas, São Paulo, Brazil, 13060-904
Actively Recruiting
14
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
15
Universidade Federal de Sao Paulo - UNIFES
São Paulo, Brazil, 04024-002
Active, Not Recruiting
16
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
17
Hospital Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
18
CH de Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
19
Hôpital Robert Debré
Paris, France, 75019
Actively Recruiting
20
Hop Necker Enfants Malades
Paris, France, 75743
Actively Recruiting
21
CHU de Toulouse - Hôpital des Enfants
Toulouse, France, 31000
Actively Recruiting
22
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy, 00165
Actively Recruiting
23
IRCCS G. Gaslini
Genoa, Liguria, Italy, 16148
Actively Recruiting
24
Clinica Pediatrica II De Marchi
Milan, Lombardy, Italy, 20122
Actively Recruiting
25
CREA Hospital Mexico Americano
Guadalajara, Jalisco, Mexico, 44620
Actively Recruiting
26
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico, 06700
Actively Recruiting
27
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
28
Instituto de Ginecología y Reproducción
Lima, Peru
Active, Not Recruiting
29
Clinica El Golf
San Isidro, Peru, L27 Lima
Active, Not Recruiting
30
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-294
Actively Recruiting
31
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun, Poland, 87-100
Withdrawn
32
Saint-Petersburg State
St-peterburg, Sankt-Peterburg, Russia, 194100
Withdrawn
33
Red Cross War Memorial Children?s Hospital
Cape Town, South Africa, 7700
Withdrawn
34
Groote Schuur Hospital
Cape Town, South Africa, 7925
Withdrawn
35
Panaroma Medical Center
Panorama, South Africa, 7500
Actively Recruiting
36
Hospital Sant Joan De Deu
Esplugas de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
37
Hospital Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
38
Hospital de La Paz
Madrid, Spain, 28046
Actively Recruiting
39
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, Spain, 46026
Actively Recruiting
40
Royal Hospital For Children
Glasgow, United Kingdom, G51 4TF
Withdrawn
41
Alder Hey Childrens Hospital
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
42
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
R
Reference Study ID Number: WA42985 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here