Lupus NephritisPhase 2OBLUMENNCT07721363
Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial
A Phase 2 study testing Obinutuzumab in people with Lupus Nephritis and Membranous Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Nephritis, Membranous Nephropathy
- What is being tested?
- Obinutuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2026to 2 Sep 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of SLE fulfilling the 2019 EULAR/ACR classification criteria (score > 10)
- Age from 18 to 75 years old included
- Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN/RPS 2003 criteria AND
- Nephrotic range proteinuria (UPCr or UACr > 3 g/g) at screening visit OR
- Uncontrolled proteinuria after at least 3 months of well-conducted anti-proteinuric therapy [UPCR> 1 g/g despite maximal or maximally tolerated dose of ACEi or ARB + SGLT2i therapy +/- diuretic therapy] and up to 12 months after pure class V lupus nephritis diagnosis.
- For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion)
Show all 9Show fewer
- Signature of informed consent
- French social security affiliation (beneficiary or legal)
- Time interval between kidney biopsy showing pure class V LN and baseline visit of no more than 12 months
Who cannot join
- Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A)
- Negativity for anti-nuclear antibodies (< 1/80) on immunofluorescence assay
- Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (> 1 mg/kg/day) corticosteroids.
- Receipt of any of the following excluded therapies:
- Any anti-CD20 therapy such as rituximab, ocrelizumab, or ofatumumab less than 6 months prior to screening or during screening. If an anti-CD20 therapy has been received between 6 and 12 months prior to screening, the peripheral CD19+ B-cell count by flow cytometry must be > 25 cells/µL
- Cyclophosphamide, tacrolimus, ciclosporin, mycophenolate mofetil, pulse methylprednisolone or voclosporin during the 2 months prior to screening or during screening. Patients maintained on low-dose corticosteroids (<10 mg/day prednisone equivalent) for a prolonged period as part of the management of a previous and resolved flare are eligible for trial participation.
Show all 18Show fewer
- Any biologic therapy (other than anti-CD20) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept during the 2 months prior to screening or during screening
- Oral inhibitors of Janus-associated kinase (JAK), Bruton's tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib or any investigational agent during the 2 months prior to screening or during screening
- Any live vaccine during the 28 days prior to screening or during screening
- Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients.
- Fewer than 10 non-sclerosed glomeruli analyzable on renal biopsy
- Ongoing pregnancy or breastfeeding women
- CKD stage 4 or 5, defined as eGFR <30 ml/min/1.73m2 according to CKD-EPI creatinine equation measured two times in an interval of 3 months (to be dissociated from acute kidney injury).
- Obsolescence of more than 60% of glomeruli or tubulo-interstitial scarring of more than 60% on kidney biopsy.
- Patients already included in an interventional study (RIPH1, clinical investigation or clinical trial)
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- Patients with a previously documented kidney disease causing proteinuria (> 3 g/g or > 3 g/day) more than 1 year prior to the diagnosis of pure class V LN.
- Exclusion of primary membranous nephropathy, defined by positive anti-PLA2R antibodies on serum and/or glomerular PLA2R staining on kidney biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Sorbonne University - Nephrology Départment - Tenon APHP
Paris, France, 75012
Romain Brousse, Dr, +33 1 56 01 70 43, romain.brousse@aphp.fr
Jean-Jacques BOFFA, Pr, +33 1 56 01 69 99, jean-jacques.boffa@aphp.fr
About this study
Official title: Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial (OBLUMEN)
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)
Read the detailed description
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.
- Conditions
- Lupus Nephritis, Membranous Nephropathy
- Being tested
- Obinutuzumab
- Keywords
- Class V lupus nephritis, Pure lupus membranous nephropathy, Systemic lupus erythematosus, Membranous nephropathy, Obinutuzumab, B-cell targeted therapy
- Medical subject headings
- Lupus Nephritis, Glomerulonephritis, Membranous, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called GAZYVARO
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
| Study group | Role | What they receive |
|---|---|---|
| pure class V lupus nephritis in adult patients | Experimental | Not described Receives: Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.
Secondary outcomes (10)
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
Measured: 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
Measured: 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.
- Unit: Percentage of participants (%)
Measured: 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
Measured: 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)
- Unit: Number of flares / categorical severity
Measured: 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
- Unit: Number of flares
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: first obinutuzumab infusion to week 52 (week 48 to week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start2 Sep 2026 (estimated)
- Primary completion2 Sep 2029 (estimated)
- Study completion2 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- Romain Brousse, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721363
- Sponsor's protocol ID
- APHP240937
- Other IDs
- 2024-519985-35-00
- Acronym
- OBLUMEN
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial (OBLUMEN)
- ClinicalTrials.gov ID
- NCT07721363
- Acronym / sponsor ID
- OBLUMEN / APHP240937
- Conditions
- Lupus Nephritis, Membranous Nephropathy
- Keywords
- Class V lupus nephritis, Pure lupus membranous nephropathy, Systemic lupus erythematosus, Membranous nephropathy, Obinutuzumab, B-cell targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Roche-Genentech
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 2 Sep 2029 (estimated)
- Study completion
- 2 Sep 2029 (estimated)
- First posted
- 23 Jul 2026 (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.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pure class V lupus nephritis in adult patients | Experimental | Drug: Obinutuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of SLE fulfilling the 2019 EULAR/ACR classification criteria (score > 10)
- Age from 18 to 75 years old included
- Pure class V lupus nephritis, defined on a renal biopsy sample following the ISN/RPS 2003 criteria AND
- For women of childbearing age, agreement to remain abstinent (refrain from heterosexual intercourse) or willingness to use appropriate and effective contraception, as recommended when using obinutuzumab (18 months after last infusion)
- Signature of informed consent
Key exclusion criteria (18 listed)
- Ongoing treatment (induction or maintenance) for proliferative LN (class III-A or IV-A)
- Negativity for anti-nuclear antibodies (< 1/80) on immunofluorescence assay
- Severe extra-renal (i.e but not limited to : cardiac, central nervous system, pulmonary, enteric) lupus flare requiring high dose (> 1 mg/kg/day) corticosteroids.
- Receipt of any of the following excluded therapies:
- Contraindication to the use of obinutuzumab, its premedication drugs or hypersensitivity to its excipients.
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 |
|---|---|---|
| ObinutuzumabAlso: GAZYVAROObinutuzumab, 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 | Drug | pure class V lupus nephritis in adult patients |
Primary outcome
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.
Time frame: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.
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
10 secondary outcomes
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
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
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
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
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
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
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).
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
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the quality of life of patients at W52
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
To assess the quality of life of patients at W52
Time frame: first obinutuzumab infusion to week 52 (week 48 to week 56)
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 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
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
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
Romain Brousse, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obinutuzumab in people with Lupus Nephritis and Membranous Nephropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 23 Jul 2026. 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 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 Romain Brousse, Dr (+33 1 56 01 70 43, romain.brousse@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: week 52 (week 48 to week 56) after the first infusion of obinutuzumab.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.