PER-051-21RecruitingPhase 2
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH ACTIVE CLASS III OR IV LUPUS NEPHRITIS, INCLUDING AN EVALUATION OF OPEN LABEL SAFETY AND PK IN A COHORT OF PEDIATRIC PATIENTS (AGED 5 to < 12).
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- F. HOFFMANN-LA ROCHE LTD.
- Enrollment
- 2
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Significant proteinuria defined by a urine protein-to-creatinine ratio (UPCR) above > 0.5 based on a first-morning void (FMV) collection at screening.
- •Participants who are age 12 to < 18 years at the time of randomization.
- •Ability to comply with the study protocol, in the investigator's judgment.
- •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.
- •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 treatment of the current episode of active LN.
- •– Where possible, pulse steroids should be completed prior to screening.
- •– The maximum permitted cumulative dose of pulse steroids during the 4 weeks prior to randomization or during screening is 3 g methylprednisolone IV or
- •equivalent.
- •Participants who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in the protocol.
- •For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined below:
- •Females must remain abstinent or use two contraceptive methods with a failure rate of < 1% per year during the treatment period and for 18 months after the final dose of obinutuzumab and for 6 weeks after the final dose of MMF.
- •A female is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
- •Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, proper
Exclusion Criteria
- •Participants who are 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.
- •Females of childbearing potential must have a negative serum pregnancy test result within 28 days prior to initiation of study treatment and a negative urine pregnancy test at Day 1 prior to randomization.
- •Sclerosis in > 50% of glomeruli on renal biopsy.
- •Pure Class V LN.
- •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 completion of oral anti-infectives
- •within 2 weeks prior to randomization.
- •– Entry into this study may be reconsidered once the infection has fully resolved.
- •Evidence of active tuberculosis (TB) infection.
- •Testing for latent TB will be performed at screening if required by local regulations or in accordance with local clinical practice.
- •Latent TB after completion of appropriate treatment is not exclusionary.
- •History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders.
- •For participants with unknown HIV status, HIV testing may be performed at screening if required by local regulations.
- •History of serious recurrent or chronic infection.
- •History of progressive multifocal leukoencephalopathy (PML).
- •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 past 5 years.
- •Major surgery requiring hospitalization during the 4 weeks prior to screening or
- •during screening.
- •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.
- •Receipt of any of
Investigators
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