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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
EU CTIS ID: 2023-503628-22-00
What this study is testing
1. To evaluate the efficacy of obinutuzumab (combined treatment groups) compared with placebo based on the proportion of patients who achieve a complete renal response (CRR) at Week 76
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Active or active/chronic International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV proliferative LN by renal biopsy performed in the 6 months prior to screening or during screening
- 2. Systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III or IV LN (above) and current or past positive antinuclear antibody (ANA), as evidenced by ANA at a titer of >= 1:80 on hEp-2 cells or an equivalent positive ANA test at least once
- 3. Urinary protein-to-creatinine ratio (UPCR) ≥ 1 g/g on a 24-hour collection at screening
- 4. Receipt of at least one dose of pulse methylprednisolone IV (≥ 250 mg) or equivalent for treatment of the current episode of active LN during the 6 months prior to screening or during screening; or to be given on Day 1 prior to the first infusion. A maximum of 3 g methylprednisolone IV or equivalent during the 4 weeks prior to screening or during screening is allowed
You likely can't join if
- 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo or within 6 weeks after the final dose of MMF
- 2. Severe renal impairment, as defined by eGFR < 30 mL/min/1.73 m2 or the need for dialysis or renal transplantation
- 3. Sclerosis in > 50% of glomeruli on renal biopsy
- 4. Presence of rapidly progressive glomerulonephritis
- 5. Severe, active central nervous system SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
- 6. High risk for clinically-significant bleeding or any condition requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Brazil
- Peru
- United Kingdom
- South Africa
- Russian Federation
- Canada
- United States
- Israel
- Mexico
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Brazil; Peru; United Kingdom; South Africa; Russian Federation and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.