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Tests treatment safety and results for Lupus Nephritis
Official title 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
ClinicalTrials.gov ID: NCT05039619
What this study is testing
What is Obinutuzumab?
Obinutuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Also referred to as Gazyva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- Participants who are age 12 to \<18 years at the time of randomization
- Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be...
- International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed...
- Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
- Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
You likely can't join if
- Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke...
- Sclerosis in \>50% of glomeruli on renal biopsy
- Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
- Presence of rapidly progressive glomerulonephritis
- Pure Class V LN
- Intolerance or contraindication to study therapies
See the full eligibility criteria
- Participants who are age 12 to \<18 years at the time of randomization
- Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger...
- International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
- Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
- Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
- Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening
- During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the...
- Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
- Sclerosis in \>50% of glomeruli on renal biopsy
- Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
- Presence of rapidly progressive glomerulonephritis
- Pure Class V LN
- Intolerance or contraindication to study therapies
- Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or...
- History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
- History of serious recurrent or chronic infection
- History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the...
- Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation
- Currently active alcohol or drug abuse or history of alcohol or drug abuse
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Shreveport, Louisiana, United States
- Hackensack, New Jersey, United States
- Queens, New York, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- El Paso, Texas, United States
- Salvador, Estado de Bahia, Brazil
- Campinas, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Le Kremlin-Bicêtre, France
- Paris, France
- Toulouse, France
+ 19 more site(s).
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, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Shreveport, Louisiana, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.