Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
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
Trial design
Treatments tested in this trial
- Obinutuzumab
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Roche-Genentech
Collaborator
Source ClinicalTrials.gov