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Lupus NephritisPhase 2POSTERITYNCT05039619

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

A Phase 2 study testing Obinutuzumab, Mycophenolate Mofetil and Acetaminophen/paracetamol in people with Lupus Nephritis, run by Hoffmann-La Roche at 44 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Lupus Nephritis
What is being tested?
Obinutuzumab, Mycophenolate Mofetil and Acetaminophen/paracetamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
44 sitesin 12 countries
Study dates
12 May 2022to 14 Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

44 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global.rochegenentechtrials@roche.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

44 sites in 12 countries

United States11 sites, 9 recruiting

  • Emory Children's Center

    Atlanta, Georgia, 30322

    Recruiting

  • Children's Hospital Colorado, Anchutz Medical Campus

    Aurora, Colorado, 80045

    Recruiting

  • Cincinnati Childrens Hospital

    Cincinnati, Ohio, 45229

    Recruiting

  • Texas Arthritis Center

    El Paso, Texas, 79902

    Withdrawn

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • Loma Linda University health

    Loma Linda, California, 92354

    Recruiting

  • Chldren?s Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Withdrawn

  • Cohen Children's Medical Center of New York

    Queens, New York, 11042

    Recruiting

  • UCSF Benioff Childrens Hospital

    San Francisco, California, 94158

    Recruiting

  • Louisiana State University

    Shreveport, Louisiana, 71103

    Recruiting

Other trials in United States

Brazil6 sites, 5 recruiting

  • Centro de Pesquisa São Lucas

    Campinas, São Paulo, 13060-904

    Recruiting

  • Hospital Universitário Onofre Lopes - UFRN

    Petrópolis, Rio Grande do Norte, 59012-300

    Recruiting

  • Instituto de Ensino da Saude e Gestao - IESG

    Salvado, Estado de Bahia, 40050-050

    Recruiting

  • Ser Servicos Especializados Em Reumatologia

    Salvador, Estado de Bahia, 40150-150

    Recruiting

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000

    Recruiting

  • Universidade Federal de Sao Paulo - UNIFES

    São Paulo, 04024-002

    Active, not recruiting

Other trials in Brazil

France4 sites, 4 recruiting

  • CH de Bicêtre

    Le Kremlin-Bicêtre, 94275

    Recruiting

  • Hôpital Robert Debré

    Paris, 75019

    Recruiting

  • Hop Necker Enfants Malades

    Paris, 75743

    Recruiting

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, 31000

    Recruiting

Other trials in France

Spain4 sites, 3 recruiting

  • Hospital Sant Joan De Deu

    Esplugas de Llobregat, Barcelona, 08950

    Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Recruiting

  • Hospital de La Paz

    Madrid, 28046

    Recruiting

  • Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

    Valencia, 46026

    Withdrawn

Other trials in Spain

Italy3 sites, 3 recruiting

  • IRCCS G. Gaslini

    Genoa, Liguria, 16148

    Recruiting

  • Clinica Pediatrica II De Marchi

    Milan, Lombardy, 20122

    Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Rome, Lazio, 00165

    Recruiting

Other trials in Italy

Mexico3 sites, 3 recruiting

  • CREA Hospital Mexico Americano

    Guadalajara, Jalisco, 44620

    Recruiting

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700

    Recruiting

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

    Recruiting

Other trials in Mexico

South Africa3 sites, 1 recruiting

  • Red Cross War Memorial Children?s Hospital

    Cape Town, 7700

    Withdrawn

  • Groote Schuur Hospital

    Cape Town, 7925

    Withdrawn

  • Panaroma Medical Center

    Panorama, 7500

    Recruiting

Other trials in South Africa

United Kingdom3 sites, 2 recruiting

  • Royal Hospital For Children

    Glasgow, G51 4TF

    Withdrawn

  • Alder Hey Childrens Hospital

    Liverpool, L12 2AP

    Recruiting

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH

    Recruiting

Other trials in United Kingdom

Canada2 sites, 2 recruiting

  • Hospital Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Recruiting

Other trials in Canada

Peru2 sites

  • Instituto de Ginecología y Reproducción

    Lima

    Active, not recruiting

  • Clinica El Golf

    San Isidro, L27 Lima

    Active, not recruiting

Other trials in Peru

Poland2 sites, 1 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-294

    Recruiting

  • Szpital Specjalistyczny dla Dzieci i Doroslych

    Torun, 87-100

    Withdrawn

Other trials in Poland

Russia1 site

  • Saint-Petersburg State

    St-peterburg, Sankt-Peterburg, 194100

    Withdrawn

Other trials in Russia

About this study

Official title: 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)

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
Lupus Nephritis
Being tested
Obinutuzumab, Placebo, Mycophenolate Mofetil, Acetaminophen/paracetamol, Diphenhydramine hydrochloride (HCl)
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Also called Gazyva

    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.

  • PlaceboDrug

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

  • Mycophenolate MofetilDrug

    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/paracetamolDrug

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

  • Diphenhydramine hydrochloride (HCl)Drug

    Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.

  • MethylprednisoloneDrug

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

  • PrednisoneDrug

    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 groups in NCT05039619
Study groupRoleWhat they receive
Blinded ObinutuzumabExperimentalParticipants 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).
Receives: Drug: Obinutuzumab; Drug: Mycophenolate Mofetil; Drug: Acetaminophen/paracetamol; Drug: Diphenhydramine hydrochloride (HCl); Drug: Methylprednisolone; Drug: Prednisone
PlaceboPlacebo comparatorPlacebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.
Receives: Drug: Placebo; Drug: Mycophenolate Mofetil; Drug: Acetaminophen/paracetamol; Drug: Diphenhydramine hydrochloride (HCl); Drug: Methylprednisolone; Drug: Prednisone
Open-Label ObinutuzumabExperimentalYounger participants aged 5 to <12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.
Receives: Drug: Obinutuzumab; Drug: Mycophenolate Mofetil; Drug: Acetaminophen/paracetamol; Drug: Diphenhydramine hydrochloride (HCl); Drug: Methylprednisolone; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)

    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

    Measured: Week 76

  2. Percentage of Participants with Adverse Events (PP)

    Measured: Baseline to Week 76

Secondary outcomes (26)

  1. Percentage of Participants Achieving a CRR (AP)

    Measured: Weeks 24 and 52

  2. Percentage of Participants who Achieve CRR with Successful Prednisone Taper (AP)

    Measured: Week 76

  3. Percentage of Participants who Achieve a PRR (AP)

    Measured: Week 76

  4. Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP)

    PRR is defined as:

    achievement of all of the following:

    • >=50% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline
    • UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was >=3 g/g)
    • eGFR >=85% of baseline
    • No occurrence of intercurrent events

    Measured: Weeks 24, 52, and 76

  5. Change in UPCR (AP)

    Measured: Baseline to Week 76

  6. Change in eGFR (AP)

    Measured: Baseline to Week 76

  7. Time to Onset of CRR over the Course of 76 weeks (AP)

    Measured: Up to Week 76

  8. Percentage of Participants who Experience Treatment Failure (AP)

    Measured: Week 12 to Week 76

  9. Change in anti-dsDNA titers (AP)

    Measured: Baseline to Week 76

  10. Change in C3 Complement Levels (AP)

    Measured: Baseline to Week 76

  11. Change in C4 Complement Levels (AP)

    Measured: Baseline to Week 76

  12. Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (AP)

    Measured: Baseline to Week 76

  13. Serum Concentrations of Obinutuzumab (AP)

    Measured: Baseline to Week 76

  14. Percentage of Participants Achieving B-cell Depletion (AP)

    Measured: Baseline, Weeks 4, 24, 52 and 76

  15. Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PedsQL)-Fatigue Total Score (AP)

    Measured: Baseline to Week 76

  16. Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (AP)

    Measured: Baseline to Week 76

  17. Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores (AP)

    Measured: Baseline to Week 76

  18. Percentage of Participants with Anti-drug Antibodies (ADA) (AP)

    Measured: Weeks 0, 24, 52 and 76

  19. Relationship Between ADA Status and Percentage of Participants Achieving a CRR (AP)

    Measured: Weeks 24, 52 and 76

  20. Percentage of Participants Achieving a CRR (PP)

    Measured: Week 76

  21. Percentage of Participants Achieving an Overall Response (PP)

    PRR is defined as achievement of all of the following:

    • >=50% reduction in UPCR from baseline
    • UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was >=3 g/g)
    • eGFR >=85% of baseline
    • No occurrence of intercurrent events

    Measured: Week 76

  22. Percentage of Participants who Achieve CRR with Successful Prednisone Taper (PP)

    Measured: Week 76

  23. Change in eGFR (PP)

    Measured: Baseline to Week 76

  24. Percentage of Participants Achieving B-cell Depletion (PP)

    Measured: Baseline, Weeks 4, 24, 52 and 76

  25. Percentage of Participants with ADAs (PP)

    Measured: Weeks 0, 24, 52 and 76

  26. Change in anti-dsDNA titers (PP)

    Measured: Baseline to Week 76

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start12 May 2022
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion14 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039619
Sponsor's protocol ID
WA42985
Other IDs
2021-000097-29, 2023-505825-15-00, 2023
Acronym
POSTERITY
Status last verified
Nov 2026
First submitted
1 Sep 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.

    PubMed 37678236

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obinutuzumab, Mycophenolate Mofetil and Acetaminophen/paracetamol in people with Lupus Nephritis, run by Hoffmann-La Roche at 44 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Brazil, France, Spain, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global.rochegenentechtrials@roche.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) (time frame: Week 76). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05039619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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