Lupus NephritisPhase 3OBILUPNCT04702256

Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

A Phase 3 study testing Obinutuzumab administration, Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil and Administration of methylprednisolone, paracetamol and dexchlorpheniramine in people with Lupus Nephritis and Systemic Lupus Erythematosus (SLE), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

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

Sites and contacts

Official record

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Trial summary

This is a randomised, open label, controlled non-inferiority phase III multicentre trial. As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the… Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
What is being tested?: Obinutuzumab administration, Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil and Administration of methylprednisolone, paracetamol and dexchlorpheniramine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 1 siteFrance
Study dates: 9 Dec 2021to Dec 2031
Phase: Phase 3
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 14 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Children aged 14-17 years old and adults;
Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli;
Urine protein-to-creatinine ratio (uPCR) ≥ 0.5 g/g at any time in the 14 days before inclusion;
No contraindications to the use of IV methylprednisolone, MMF, oral corticosteroids or obinutuzumab;
Ability to provide informed consent;
Willingness to use appropriate contraception, as recommended when using MMF.

Who cannot join

Severe "critical" SLE flare defined as any SLE manifestation requiring more immunosuppression than allowed in the protocol, in the physician's opinion;
Patients who cannot be prescribed 10 mg prednisone corticosteroids "only", after inclusion according to the physician's opinion;
Pregnant and breastfeeding woman;
Prior use within 6 months of inclusion of therapeutic monoclonal antibody and/or B- or T cell modulating 'biologic' except belimumab that can be used up to 7 days before inclusion;
Obsolescence of >60% of the glomeruli or tubulointerstitial scarring of >60%;
CKD stage 4 or stage 5 defined as eGFR <30 ml/min/1.73 m2 according to CKD-EPI (to be differentiated from acute renal injury);

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Active infections, including but not limited to human immunodeficiency virus (HIV), hepatitis B in the absence of a specific therapy, hepatitis C or tuberculosis;
Receipt of a live-attenuated vaccine in the 4 weeks prior to study enrolment;
History of cervical dysplasia CIN Grade III, cervical high-risk human papillomavirus or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS) in the past 3 years in female patients. However, the patient will be eligible in the following conditions: follow-up HPV test is negative or cervical abnormality was effectively treated >1 year ago.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nathalie COSTEDOAT-CHALUMEAU, MD, PhD contact

+33 (0)6 87 50 81 23

nathalie.costedoat@gmail.com

Eric DAUGAS, MD, PhD contact

+33 (0) 1 40 25 71 01

eric.daugas@aphp.fr

France1 site, 1 recruiting

Internal medicine, Cochin hospital, APHP
Paris, 75014
Nathalie COSTEDOAT-CHALUMEAU, MD, PhD
Recruiting

Other trials in France

About this study

Official title: Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

This is a randomised, open label, controlled non-inferiority phase III multicentre trial.

As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose.

As secondary objectives, the study aims:

To compare the efficacy of the treatments in both arms in terms of:
partial plus complete renal response at week 52;
proteinuria < 0.8g/g at week 52;
extrarenal flares;
response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52.
To compare the safety of the treatments in both arms in terms of occurrence of:
toxicity of corticosteroids;
serious Adverse Events;
serious Infectious Episodes;
new damage.
To compare the number of patients with non-adherence to treatment in both arms.
To estimate the efficiency of obinutuzumab in this indication.

The ancillary studies will allow:

To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not).
To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study).
To have long term data on renal function and damage.

Read the detailed description

Preliminary data show that the anti CD20 monoclonal antibody may effectively replace oral corticosteroids in the induction treatment of lupus glomerulonephritis. The concept of avoiding significant use of corticosteroids would mark a step change in the approach to the treatment of lupus nephritis but the efficacy of such a strategy first needs to be confirmed in a randomised controlled study.

The main aim of this study is to demonstrate that patients with lupus nephritis could be treated successfully without using damaging doses of oral corticosteroids.

Eligible patients will be randomised with 1:1 ratio, between interventional group (obinutuzumab, IV methylprednisolone, no or low dose corticosteroids and MMF) and control group (oral prednisone, IV methylprednisolone and MMF), after signed informed consent obtaining. Randomization will be blocked and stratified by level of proteinuria (<1 g/g versus ≥ 1 g/g). Previous 52 centers will participate to the trial.

Study assessments will occur on a standard of care basis at 15 days, 1, 3, 6, 9 and 12 months (and at any flare or according to the wishes of the investigator). Study assessment will include assessment of disease activity, disease- and treatment-related damage, quality of life, and blood and urine tests as standard of care. In addition, a biobank will be sampled at inclusion. Long-term data on damage and renal function will be collected during standard of care (18 months, 2, 5 and 10 years) in patients who consented.

Population involved: Children (14 years and above) and adults with lupus nephritis ISN/RPS class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli, AND urine protein-to-creatinine ratio (uPCR) ≥ 0.5 g/g.

Data Analysis

In summary, the primary outcome is complete renal response (CR), initial analysis will be descriptive, using odds ratios and 95% confidence intervals (CIs). Formally CR will be analysed using Intention-To-Treat (ITT) analysis via logistic regression. Following the ITT principle, missing data will be imputed. The model will include the treatment effect, and the factors used for stratification in the randomisation as covariates. Odd ratios and 95% CIs derived from the logistic regression will be provided. The results (comparison between the groups) will be presented as an Odds Ratio (OR) (and a two-sided 95% CI) and the trial will be deemed to have met its objective of non-inferiority if the lower bound of the CI (equivalent to a one-sided 97.5% CI) is above a critical value of 0.45 as described above.

Secondary outcomes will be analysed using analogous models with logistic regression for binary endpoints, Cox regression for time-to-event endpoints and multiple linear regression for continuous endpoints. Where appropriate, repeated measures analyses will also be used. The tests will however be two-sided at 5%.

Conditions: Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
Being tested: Obinutuzumab administration, Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil, Administration of methylprednisolone, paracetamol and dexchlorpheniramine
Keywords: lupus nephritis, obinutuzumab, corticosteroids, non-inferiority
Medical subject headings: Lupus Nephritis, Lupus Erythematosus, Systemic

What participants receive

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

Obinutuzumab administrationDrug
Also called GAZYVARO® administration
Obinutuzumab administration by intravenous infusion (IV), IV of methylprednisolone, oral mycophenolate mofetil, no prednisone (or if required for extrarenal manifestation(s): less than 10mg/day at any time, less than 7.5mg/day after 6 months and less than 5mg/day after 9 months).
Hydroxychloroquine will be strongly recommended for all the patients.
Administration of Methylprednisolone + Prednisone + Mycophenolate mofetilDrug
Also called Corticosteroid Series
IV of methylprednisolone, oral prednisone (according to the PNDS), and oral mycophenolate mofetil.
Hydroxychloroquine will be strongly recommended for all the patients.
Administration of methylprednisolone, paracetamol and dexchlorpheniramineDrug
Also called Premedication
Prior to infusion of obinutuzumab, patients receiving obinutuzumab will receive premedication including 100 mg of methylprednisolone, paracetamol and dexchlorpheniramine.

Study groups in NCT04702256
Study group	Role	What they receive
Obinutuzumab arm	Experimental	Obinutuzumab administration plus oral mycophenolate mofetil (MMF) Receives: Drug: Obinutuzumab administration; Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramine
Corticosteroids arm	Active comparator	Oral corticosteroids plus MMF Receives: Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil

What is being measured

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

Complete renal response (CR)
CR at week 52 without receiving corticosteroids above a prespecified dose.
CR at week 52 is defined as:
- Urine PCR (protein to creatinine ratio) < 0.5 g/g in a spot urine AND:
- eGFR (estimated glomerular filtration rate using CKD-epi) ≥ 60 ml/min, or if < 60 ml/min at screening, no decline >20% compared to screening/randomisation (whichever worse)
- AND:
- In the obinutuzumab arm: with no steroids or without receiving oral corticosteroids > 10 mg/day within the first 6 month, and then, without receiving oral corticosteroids > 7.5 mg/day between 6 and 9 months and > 5 mg/day between 9 and 12 months for SLE indication (according to the French PNDS for SLE after 6 months).
- In the steroid arm: without receiving corticosteroids above the prescribed taper (according to the French PNDS for SLE, see Appendix A), including without receiving oral corticosteroids > 7.5 mg/day between 6 and 9 months and > 5 mg/day between 9 and 12 months for SLE indication (according to the French
Measured: at week 52
Proteinuria measurement
Proteinuria measurement: the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.
Measured: at baseline
Proteinuria measurement
Proteinuria measurement: the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.
Measured: at week 52

Secondary outcomes (12)

Efficacy: partial renal response (PR)
Partial renal response (PR) will be defined as:
- 50% improvement in uPCR;
- AND: uPCR between 0.5 and 3 g/g;
- AND: no more than a 20% decrease of eGFR from the baseline value (using CKD-epi).
Measured: at baseline and at week 52
Efficacy: complete renal response
Complete renal response: same as in primary outcome.
Measured: at baseline and at week 52
Efficacy: proteinuria measurement
Proteinuria measurement (same as in primary outcome): the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.
Measured: at baseline and at week 52
Efficacy: extrarenal flare
Extrarenal flare will be defined according to the SELENA-SLEDAI flare index.
Measured: at baseline and at week 52
Efficacy: changes in the SELENA-SLEDAI score
Changes in the SELENA-SLEDAI score will be measured between inclusion and week 52.
Measured: at baseline and at week 52
Safety: toxicity of corticosteroids measurement
The toxicity of corticosteroids will be measured by the Glucocorticoid Toxicity Index (GTI).
This Composite GTI will be scored (will not be measured separately) with BMI, glucose tolerance, blood pressure, lipid profile, steroid myopathy, skin, neuropsychiatric and ophthalmological toxicity and infections.
Measured: at inclusion, at Month 6 and Month 12
Safety: serious adverse events (SAE) report
The number of serious adverse events will be measured per patient according to the CTCAE toxicity grading system for the following adverse events combined: death (all causes), grade 3 or higher infections, hospitalization resulting either from the disease or from a complication due to the study treatment.
Measured: through study completion, an average of 10 years
Safety: number of serious infectious episodes
The number of serious infectious episodes will be measured per patient according to the CTCAE toxicity grading system for the following adverse events combined: death (all causes), grade 3 or higher infections.
Measured: through study completion, an average of 10 years
Safety: changes in the SLICC/ACR damage index.
New damage will be assessed by measuring changes in the SLICC/ACR damage index.
Measured: at inclusion, at Month 6 and Month 12
Non-adherence to treatment: hydroxychloroquine blood levels
Non-adherence will be defined by otherwise unexplained HCQ drug level < 200 ng/ml and/or undetectable metabolite, at least once during the follow-up visits.
Non-adherence to treatment will be assessed with hydroxychloroquine blood levels as routinely done in France.
Measured: at Month 6 and Month 12
Non-adherence to treatment: questionnaires MASRI
Non-adherence to treatment will be assessed using questionnaires MASRI.
Measured: at Month 6 and Month 12
Efficiency
The 1-year total costs of treatment in both arms will be estimated and the incremental cost effectiveness ratio as the difference in costs divided by the difference in QALys estimated from the EQ 5D self-administered questionnaire.
Measured: at one year

Timeline

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

9 Dec 2021Dec 2031

First posted8 Jan 2021
Study start9 Dec 2021
Primary completionDec 2031 (estimated)
Study completionDec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Lupus NephritisStudies of the same condition, open and under way.
More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 196 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04702256
Sponsor's protocol ID: APHP200038
Other IDs: 2020-005835-60, MEDAECNAT-2021-05-0070
Acronym: OBILUP
Status last verified: Nov 2025
First submitted: 30 Nov 2020
Last updated: 24 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tunnicliffe DJ, Palmer SC, Henderson L, Masson P, Craig JC, Tong A, Singh-Grewal D, Flanc RS, Roberts MA, Webster AC, Strippoli GF. Immunosuppressive treatment for proliferative lupus nephritis. Cochrane Database Syst Rev. 2018 Jun 29;6(6):CD002922. doi: 10.1002/14651858.CD002922.pub4.
PubMed 29957821
Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.
PubMed 22806274
Dall'Era M, Cisternas MG, Smilek DE, Straub L, Houssiau FA, Cervera R, Rovin BH, Mackay M. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol. 2015 May;67(5):1305-13. doi: 10.1002/art.39026.
PubMed 25605554
Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9.
PubMed 28925027
Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.
PubMed 23144449
Costedoat-Chalumeau N, Amoura Z, Hulot JS, Aymard G, Leroux G, Marra D, Lechat P, Piette JC. Very low blood hydroxychloroquine concentration as an objective marker of poor adherence to treatment of systemic lupus erythematosus. Ann Rheum Dis. 2007 Jun;66(6):821-4. doi: 10.1136/ard.2006.067835. Epub 2007 Feb 26.
PubMed 17324970
Costedoat-Chalumeau N, Pouchot J, Guettrot-Imbert G, Le Guern V, Leroux G, Marra D, Morel N, Piette JC. Adherence to treatment in systemic lupus erythematosus patients. Best Pract Res Clin Rheumatol. 2013 Jun;27(3):329-40. doi: 10.1016/j.berh.2013.07.001.
PubMed 24238690
Jolly M, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin DL, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Hulot JS, Arora S, Amoura Z, Piette JC, Costedoat-Chalumeau N; PLUS group. Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels. Lupus. 2016 Jun;25(7):735-40. doi: 10.1177/0961203315627200. Epub 2016 Feb 13.
PubMed 26876692
Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
PubMed 33693991

Interested in taking part?

Nathalie COSTEDOAT-CHALUMEAU, MD, PhD

+33 (0)6 87 50 81 23

nathalie.costedoat@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
ClinicalTrials.gov ID: NCT04702256
Acronym / sponsor ID: OBILUP / APHP200038
Conditions: Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
Keywords: lupus nephritis, obinutuzumab, corticosteroids, non-inferiority
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 196 participants (estimated)
Lead sponsor: Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
Collaborators: Roche Pharma AG
Study start: 9 Dec 2021 (actual)
Primary completion: Dec 2031 (estimated)
Study completion: Dec 2031 (estimated)
First posted: 8 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a randomised, open label, controlled non-inferiority phase III multicentre trial.

As secondary objectives, the study aims:

To compare the efficacy of the treatments in both arms in terms of:
partial plus complete renal response at week 52;
proteinuria < 0.8g/g at week 52;
extrarenal flares;
response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52.
To compare the safety of the treatments in both arms in terms of occurrence of:
toxicity of corticosteroids;
serious Adverse Events;
serious Infectious Episodes;
new damage.
To compare the number of patients with non-adherence to treatment in both arms.
To estimate the efficiency of obinutuzumab in this indication.

The ancillary studies will allow:

To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not).
To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study).
To have long term data on renal function and damage.

Detailed description

The main aim of this study is to demonstrate that patients with lupus nephritis could be treated successfully without using damaging doses of oral corticosteroids.

Data Analysis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Obinutuzumab arm	Experimental	Drug: Obinutuzumab administration, Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramineObinutuzumab administration plus oral mycophenolate mofetil (MMF)
Corticosteroids arm	Active comparator	Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetilOral corticosteroids plus MMF

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Children aged 14-17 years old and adults;
Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesions in at least 10% of the viable glomeruli;
Urine protein-to-creatinine ratio (uPCR) ≥ 0.5 g/g at any time in the 14 days before inclusion;
No contraindications to the use of IV methylprednisolone, MMF, oral corticosteroids or obinutuzumab;
Ability to provide informed consent;

Key exclusion criteria (9 listed)

Severe "critical" SLE flare defined as any SLE manifestation requiring more immunosuppression than allowed in the protocol, in the physician's opinion;
Patients who cannot be prescribed 10 mg prednisone corticosteroids "only", after inclusion according to the physician's opinion;
Pregnant and breastfeeding woman;
Prior use within 6 months of inclusion of therapeutic monoclonal antibody and/or B- or T cell modulating 'biologic' except belimumab that can be used up to 7 days before inclusion;
Obsolescence of >60% of the glomeruli or tubulointerstitial scarring of >60%;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Obinutuzumab administrationAlso: GAZYVARO® administrationObinutuzumab administration by intravenous infusion (IV), IV of methylprednisolone, oral mycophenolate mofetil, no prednisone (or if required for extrarenal manifestation(s): less than 10mg/day at any time, less than 7.5mg/day after 6 months and less than 5mg/day after 9 months). Hydroxychloroquine will be strongly recommended for all the patients.	Drug	Obinutuzumab arm
Administration of Methylprednisolone + Prednisone + Mycophenolate mofetilAlso: Corticosteroid SeriesIV of methylprednisolone, oral prednisone (according to the PNDS), and oral mycophenolate mofetil. Hydroxychloroquine will be strongly recommended for all the patients.	Drug	Corticosteroids arm
Administration of methylprednisolone, paracetamol and dexchlorpheniramineAlso: PremedicationPrior to infusion of obinutuzumab, patients receiving obinutuzumab will receive premedication including 100 mg of methylprednisolone, paracetamol and dexchlorpheniramine.	Drug	Obinutuzumab arm

Primary outcome

Complete renal response (CR)
Time frame: at week 52
CR at week 52 without receiving corticosteroids above a prespecified dose. CR at week 52 is defined as: * Urine PCR (protein to creatinine ratio) < 0.5 g/g in a spot urine AND: * eGFR (estimated glomerular filtration rate using CKD-epi) ≥ 60 ml/min, or if < 60 ml/min at screening, no decline >20% compared to screening/randomisation (whichever worse) * AND: * In the obinutuzumab arm: with no steroids or without receiving oral corticosteroids > 10 mg/day within the first 6 month, and then, without receiving oral corticosteroids > 7.5 mg/day between 6 and 9 months and > 5 mg/day between 9 and 12 months for SLE indication (according to the French PNDS for SLE after 6 months). * In the steroid arm: without receiving corticosteroids above the prescribed taper (according to the French PNDS for SLE, see Appendix A), including without receiving oral corticosteroids > 7.5 mg/day between 6 and 9 months and > 5 mg/day between 9 and 12 months for SLE indication (according to the French
Proteinuria measurement
Time frame: at baseline
Proteinuria measurement: the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.
Proteinuria measurement
Time frame: at week 52
Proteinuria measurement: the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.

12 secondary outcomes

Efficacy: partial renal response (PR)
Time frame: at baseline and at week 52
Efficacy: complete renal response
Time frame: at baseline and at week 52
Efficacy: proteinuria measurement
Time frame: at baseline and at week 52
Efficacy: extrarenal flare
Time frame: at baseline and at week 52
Efficacy: changes in the SELENA-SLEDAI score
Time frame: at baseline and at week 52
Safety: toxicity of corticosteroids measurement
Time frame: at inclusion, at Month 6 and Month 12
Safety: serious adverse events (SAE) report
Time frame: through study completion, an average of 10 years
Safety: number of serious infectious episodes
Time frame: through study completion, an average of 10 years
Safety: changes in the SLICC/ACR damage index.
Time frame: at inclusion, at Month 6 and Month 12
Non-adherence to treatment: hydroxychloroquine blood levels
Time frame: at Month 6 and Month 12
Non-adherence to treatment: questionnaires MASRI
Time frame: at Month 6 and Month 12
Efficiency
Time frame: at one year

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Background: PubMed 29957821Tunnicliffe DJ, Palmer SC, Henderson L, Masson P, Craig JC, Tong A, Singh-Grewal D, Flanc RS, Roberts MA, Webster AC, Strippoli GF. Immunosuppressive treatment for proliferative lupus nephritis. Cochrane Database Syst Rev. 2018 Jun 29;6(6):CD002922. doi: 10.1002/14651858.CD002922.pub4.
Background: PubMed 22806274Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.
Background: PubMed 25605554Dall'Era M, Cisternas MG, Smilek DE, Straub L, Houssiau FA, Cervera R, Rovin BH, Mackay M. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol. 2015 May;67(5):1305-13. doi: 10.1002/art.39026.
Background: PubMed 28925027Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9.
Background: PubMed 23144449Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.
Background: PubMed 17324970Costedoat-Chalumeau N, Amoura Z, Hulot JS, Aymard G, Leroux G, Marra D, Lechat P, Piette JC. Very low blood hydroxychloroquine concentration as an objective marker of poor adherence to treatment of systemic lupus erythematosus. Ann Rheum Dis. 2007 Jun;66(6):821-4. doi: 10.1136/ard.2006.067835. Epub 2007 Feb 26.
Background: PubMed 24238690Costedoat-Chalumeau N, Pouchot J, Guettrot-Imbert G, Le Guern V, Leroux G, Marra D, Morel N, Piette JC. Adherence to treatment in systemic lupus erythematosus patients. Best Pract Res Clin Rheumatol. 2013 Jun;27(3):329-40. doi: 10.1016/j.berh.2013.07.001.
Background: PubMed 26876692Jolly M, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin DL, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Hulot JS, Arora S, Amoura Z, Piette JC, Costedoat-Chalumeau N; PLUS group. Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels. Lupus. 2016 Jun;25(7):735-40. doi: 10.1177/0961203315627200. Epub 2016 Feb 13.
Derived from this study: PubMed 33693991Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Nathalie COSTEDOAT-CHALUMEAU, MD, PhD contact

+33 (0)6 87 50 81 23

nathalie.costedoat@gmail.com

Eric DAUGAS, MD, PhD contact

+33 (0) 1 40 25 71 01

eric.daugas@aphp.fr

Nathalie COSTEDOAT-CHALUMEAU, MD, PhD principal investigator

Centre de référence maladies auto-immunes et systémiques rares, Internal medicine, Cochin hospital, APHP

Eric DAUGAS, MD, PhD study director

Nephrology department, Bichat Hospital, APHP, Paris

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 9 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Nathalie COSTEDOAT-CHALUMEAU, MD, PhD (+33 (0)6 87 50 81 23, nathalie.costedoat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete renal response (CR) (time frame: at week 52). The study lists 3 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 NCT04702256, which also lists 9 linked publications.

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 24 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.