A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)



Status:Active, not recruiting
Conditions:Lupus, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:3/31/2019
Start Date:November 13, 2015
End Date:December 25, 2019

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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate
mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with
proliferative LN.


Inclusion Criteria:

- Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College
of Rheumatology (ACR) criteria

- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS)
2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior
to or during screening. Participants may co-exhibit Class V disease in addition to
either Class III or Class IV disease

- Proteinuria (urine protein to creatinine ratio) greater than (>) 1.0

- For women who are not postmenopausal (greater than or equal to [>/=] 12 months of
non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or
uterus): agreement to remain abstinent or use two adequate methods of contraception,
including at least one method with a failure rate of less than (<) 1 percent (%) per
year, during the treatment period and for at least 18 months after the last dose of
study drug

- For men: agreement to remain abstinent or use a condom plus an additional
contraceptive method that together result in a failure rate of <1% per year during the
treatment period and for at least 12 months after the last dose of study drug and
agreement to refrain from donating sperm during this same period

Exclusion Criteria:

- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis,
stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and
resulting from SLE

- Presence of rapidly progressive glomerulonephritis

- Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) <30
milliliters per minute (mL/min) or the need for dialysis or renal transplant

- Greater than 50% of glomeruli with sclerosis on renal biopsy

- Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to
randomization

- Unstable disease with thrombocytopenia or at high risk for developing clinically
significant bleeding or organ dysfunction requiring therapies such as plasmapheresis
or acute blood or platelet transfusions

- History of severe allergic or anaphylactic reactions to monoclonal antibodies or known
hypersensitivity to any component of the obinutuzumab infusion

- Significant or uncontrolled medical disease in any organ system not related to SLE or
LN, which, in the investigator's opinion, would preclude participant participation

- Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that
required oral or systemic steroid use in the 52 weeks prior to screening

- Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy
within 12 months

- Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20)
within 6 months of randomization

- Known intolerance to MMF or MPA
We found this trial at
16
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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49 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
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8750 Wilshire Boulevard
Beverly Hills, California 90211
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470 Clarkson Avenue
Brooklyn, New York 11203
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725 Uruguay
Buenos Aires, C1015ABO
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395 West 12th Avenue
Columbus, Ohio 43210
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1601 E 19th Avenue
Denver, Colorado 80218
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Fontana, CA
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Mesquite, Texas 75150
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma 73104
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Palo Alto, California 94304
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1501 Kings Highway
Shreveport, Louisiana 71103
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Tulsa, OK
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