A Phase 2 interventional study of Obinutuzumab in Lupus Nephritis and Membranous Nephropathy, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Among 33 studies in Lupus Nephritis with a site in France — 9 open to participants now, 14 under way, 5 of them phase 3. Lupus Nephritis · France.
Among the 33 studies in Lupus Nephritis with a site in France, this one is the 25th largest by planned enrollment of the 30 interventional ones that give a count, is one of 2 that started in 2026, is one of 13 in phase 2, reaches primary completion later than 9 of the 13 other live ones, and was the 32nd registered.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
Browse Lupus Nephritis studies →9 of the 33 studies in Lupus Nephritis with a site in France are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in France, United States, Germany and 3 more countries
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Sites in France, United States, Australia and 7 more countries
Novartis Pharmaceuticals · Sites in France, United States, Brazil and 15 more countries
GlaxoSmithKline · Sites in France, United States, Italy and 1 more country
Fate Therapeutics · Sites in France, United States, Sweden and 1 more country
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 14 · Phase 3 9
First in 2005; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 65 is above the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Median enrollment 124 across the 30 interventional studies, 87 across the 3 observational. Of the 19 that completed or were terminated, 12 (63%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 33 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 3 studies filed under Lupus Nephritis — fewer than ten, so there is no comparison to draw.
3 of the studies in Lupus Nephritis with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT05126277Phase 3Novartis PharmaceuticalsSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | 2027-09-21 |
| NCT06308978Fate TherapeuticsA Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease | 2027-09-30 |
Among the 33 studies in Lupus Nephritis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Lupus nephritis (LN) is a frequent and severe complication of systemic lupus erythematosus, with important mortality and morbidity. International 2024 guidelines recommend immunosuppressive therapy (MMF, cyclophosphamide, calcineurin inhibitors, rituximab, azathioprine) in patients with heavy or uncontrolled proteinuria, but none of these therapies has been evaluated in robust multicenter prospective. Therefore, no treatment has regulatory approval for pure class V LN.
Obinutuzumab, a 2nd-generation B-cell targeting therapy, is more efficient than rituximab in inducing B-cell depletion and complete renal response in patient with class III or IV lupus nephritis.
This study aims to assess the efficacy and safety of an obinutuzumab monotherapy in patients with pure class V LN. The primary endpoint is complete renal response at week 52 according to 2024 KDIGO criteria (UPCR \< 0.5 g/g, eGFR ≥ 85% of baseline, and no intercurrent event: treatment failure, rescue therapy, long-term dialysis, renal transplantation, death or early trial withdrawal)
Lupus nephritis (LN) is a frequent manifestation of systemic lupus erythematosus and conveys important risk of morbidity and mortality in affected patients. Pure class V LN, also referred to as lupus membranous nephropathy, remains difficult to manage despite available therapy. Current immunosuppressive options proposed in the 2024 international recommendations include mycophenolate mofetil, cyclophosphamide, calcineurin inhibitors, rituximab or azathioprine in situations of uncontrolled or nephrotic proteinuria. However, none of these drugs has been validated through prospective multicenter protocol-based trials specifically dedicated to assess their efficacy and safety in pure class V LN. Therefore no therapy holds specific approval for this condition.
Observational data from multiple French centers highlight the heterogeneous therapeutic choices and variable response rates obtained with treatments. Although efficacy appears broadly similar across these strategies, concerns persist regarding infertility, teratogenicity, myelotoxicity and corticosteroid exposure, reinforcing the need for alternatives with improved tolerance. Rituximab is increasingly used to treat pure lupus membranous nephropathy but is less efficient than obinutuzumab in inducing complete renal response in class III or IV lupus nephritis.
Obinutuzumab is a second-generation therapy targeting B cells, developed to enhance activity compared with rituximab. Clinical studies conducted in follicular lymphoma and chronic lymphocytic leukemia demonstrated superior outcomes and supported its approval. In LN, evaluations combining obinutuzumab with standard-of-care therapy in proliferative classes (NOBILITY and REGENCY trials) reported higher complete renal response than placebo with acceptable safety, although events such as infections, serious adverse events, neutropenia and infusion-related reactions were documented. In contrast, a study using rituximab with standard-of-care therapy (LUNAR) did not show improvement in complete renal response.
Based on these findings, this phase 2 study evaluates obinutuzumab monotherapy in adults with pure class V LN. The main endpoint is complete renal response at week 52 after first infusion, defined by urinary protein creatinine ratio \< 0.5 g/g on 24-hour urine collection, eGFR ≥ 85% of baseline, and absence of intercurrent events including treatment failure, need for rescue therapy, high-dose corticosteroids, long-term dialysis, renal transplantation, death or premature withdrawal.
Secondary objectives include: assessment of safety by recording adverse events, serious adverse events and events of interest (neutropenia, infection, infusion-related events, new cancer) from first infusion to week 52; evaluation of renal outcomes documenting no kidney response, partial renal response, complete renal response and renal relapses free of intercurrent event; monitoring of systemic lupus erythematosus activity based on immunologic remission defined by C3 and C4 normalization and anti-dsDNA negativation, as well as renal and extrarenal flares; estimation of participants without corticosteroids at week 52; and evaluation of quality of life at week 52.
The trial uses a single-arm, open, non-comparative A'Hern phase II design (Category 2, Phase 2). This protocol aims to generate prospective data on the activity and safety of obinutuzumab monotherapy in pure class V LN, with precise definitions of renal response, systematic follow-up of adverse events and detailed assessment of systemic and renal outcomes over a 52-week period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pure class V lupus nephritis, defined on a renal sample following the ISN/RPS 2003 criteria AND
Exclusion Criteria:
Receipt of any of the following excluded therapies:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Obinutuzumab
Obinutuzumab, 1000 mg, solution for dilution for infusion, 2 infusions spaced 15 days apart (day 1, day 15) +/- two additional 1000 mg infusions at week 24 and week 26 in patients with no kidney response at week 24, slow intravenous infusion, maximum 4 injections in 7 months
Also known as: GAZYVARO
To assess, in patients with pure class V lupus nephritis, the efficacy of obinutuzumab to reach complete renal response as defined by 2024 international KDIGO guidelines, 52 weeks after the first obinutuzumab infusion.
The primary endpoint is therapeutic success at Week 52 (W52) after the first obinutuzumab infusion, defined as: Complete Renal Response (CRR) of pure class V LN, as defined by the international KDIGO 2024 guidelines, as follows: * Urine Protein-to-Creatinine Ratio (UPCR) \< 0.5 g/g measured from a 24-hour urine collection AND * An eGFR ≥ 85% of the baseline value (assessed using the 2021 CKD-EPI creatinine equation), with baseline defined as the last non-missing value prior to receipt of the first obinutuzumab infusion. AND o No intercurrent event, including: * Use of rescue therapy (i.e., another immunosuppressive agent used to achieve remission, including: mycophenolate mofetil, cyclophosphamide, tacrolimus, cyclosporine, or azathioprine) or high-dose corticosteroids (\> 1 mg/kg/day of prednisone equivalent) OR * Occurrence of end-stage renal disease (CKD-EPI 2021 eGFR \< 15 mL/min/1.73 m², long-term dialysis, or pre-emptive kidney transplantation) OR * Death from any cause
Time frame: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.
To assess the safety of obinutuzumab in patients with pure class V lupus nephritis by quantifying adverse events, serious adverse events, and adverse events of special interest between the first obinutuzumab infusion and W52
collection, analysis and quantification of adverse events according to the CTCAE v5.0
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the overall efficacy of obinutuzumab on pure class V lupus nephritis by quantifying the proportion of patient with no-kidney response, partial response (PRR), complete response (CRR) and renal relapses without any intercurrent event
* Proportion of patients with complete renal response (urinary protein creatinine ratio \< 0.5 g/g on 24-hour urine collection, eGFR ≥ 85% of baseline, and absence of intercurrent events * Proportion of patients with partial renal response (decrease of UPCR \> 50% and an UPCR of \< 3 g/g measured from a 24-h urine collection * Proportion of patient with no kidney response (reaching none of the above response) * Renal relapses definition * After reaching PRR or CRR * Increase of urine protein/creatinine ratio (UPCR) \> 50% and increase of \> 1 g/g measured from a 24-h urine collection * On two consecutive urine samples spaced by an interval of at least 1 month * Identified at any time 3 months after the first obinutuzumab infusion onward and before primary endpoint assessment
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the efficacy of obinutuzumab on overall SLE activity by quantifying the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during f
Proportion of patients with negativation of anti-dsDNA and normalization of complement C3 and C4 according to local laboratory limits. o Unit: Percentage of participants (%)
Time frame: First obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the efficacy of obinutuzumab on overall SLE activity by quantifying the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during f
Disease activity assessed using the Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) * Unit: Score * Range: 0 to 105 * Interpretation: Higher scores indicate worse disease activity
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the efficacy of obinutuzumab on overall SLE activity by quantifying the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during f
Assessed using the SELENA Flare Index (SFI) o Unit: Number of flares / categorical severity
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the efficacy of obinutuzumab on overall SLE activity by quantifying the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares
Total cumulative number of SLE flares at Week 52 o Unit: Number of flares
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the proportion of patients that are free from corticosteroids at W52 with respect to corticosteroids indication (to treat lupus or another disease).
proportion of patient without any steroid prescription to treat SLE at week 52.
Time frame: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.
To assess the quality of life of patients at W52
Health-related quality of life assessed using the EQ-5D-5L descriptive system. Utility index calculated using the French value set (Andrade et al., 2020). Range: -0.530 to 1.000; higher scores indicate better health-related quality of life. Unit: utility index score
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the quality of life of patients at W52
Self-rated overall health status assessed using the EQ-5D-5L Visual Analogue Scale. Range: 0 to 100; higher scores indicate better self-rated health. Unit: score on a scale (0-100)
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the quality of life of patients at W52
Quality of life assessed using the Lupus Quality of Life (LupusQoL) questionnaire (French version). * Unit of Measure : Score * Range: 0 to 100 * Interpretation: Higher scores indicate better quality of life
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 33 phase 2 interventional studies under Lupus Nephritis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 57. This study's planned 36 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Obinutuzumab
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