A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
- Conditions
- lupus nephritisMedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-004034-42-PL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
- Age 18-75 years
- Ability to comply with the study protocol, in the investigator's
judgment
- 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
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- 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
- Urinary protein-to-creatinine ratio >= 1 g/g on a 24-hour collection
at screening
- 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.
- For women of childbearing potential: agreement to remain abstinent
or use highly effective contraception, women must remain abstinent or
use two reliable methods of contraception, including at least one method
with a failure rate of < 1% per year, during study treatment and for 18
months after the final dose of obinutuzumab and 6 weeks after the final
dose of mycophenolate mofetil (MMF)
- For men: agreement to remain abstinent or use contraceptive
methods, and agreement to refrain from donating sperm, with a female
partner of childbearing potential, men who are not surgically sterile
must remain abstinent or use a condom plus an additional contraceptive
method used by the female partner that together result in a failure rate
of < 1% per year during the treatment period and for 90 days after the
final dose of MMF, men must remain abstinent or use a condom during
the treatment period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 236
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
- 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
- Severe renal impairment, as defined by eGFR < 30 mL/min/1.73 m2
or the need for dialysis or renal transplantation
- Sclerosis in > 50% of glomeruli on renal biopsy
- Presence of rapidly progressive glomerulonephritis
- Receipt of an excluded therapy
- Severe, active central nervous system SLE, including retinitis, poorlycontrolled
seizure disorder, acute confusional state, myelitis, stroke,
cerebellar ataxia, or dementia
- High risk for clinically-significant bleeding or any condition requiring
plasmapheresis, intravenous immunoglobulin, or acute blood product
transfusions
- Significant or uncontrolled medical disease which, in the
investigators opinion, would preclude patient participation
- HIV and Tuberculosis infection; latent TB after completion of
appropriate treatment is not exclusionary.
- Active infection of any kind, excluding fungal infection of the nail
beds
- Any major episode of infection that required hospitalization or
treatment with IV or oral antibiotics or anti-infectives during the 8
weeks prior to screening or during screening.
- History of serious recurrent or chronic infection
- History of progressive multifocal leukoencephalopathy
- History of cancer, including solid tumors, hematological
malignancies, and carcinoma in situ, within the past 5 years
- Major surgery requiring hospitalization during the 4 weeks prior to
screening or during screening
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- Current alcohol or drug abuse or history of alcohol or drug abuse
within 12 months prior to screening or during screening
- Intolerance or contraindication to study therapies
- Laboratory parameters
• AST or ALT > 2.5 × upper limit of normal (ULN)
• Amylase or lipase > 2 × ULN
• Neutrophils < 1.5 × 103/µL
• Positive hepatitis B surface antigen (HBsAg)
• Positive hepatitis C serology
• Hemoglobin < 7 g/dL, unless caused by autoimmune hemolytic
anemia resulting from SLE
• Platelet count < 25,000/µL
• Positive serum human chorionic gonadotropin measured at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method