Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/2/2019
Start Date:January 19, 2017
End Date:June 29, 2019

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A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled,
parallel-group, dose-ranging study to evaluate the safety and efficacy of GDC-0853 in
combination with standard of care therapy in participants with moderate to severe active
systemic lupus erythematosus (SLE).


Inclusion Criteria:

- Fulfillment of SLE classification criteria according to either American College of
Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC)
criteria at any time prior to or at screening

- At least one serologic marker of SLE at screening as follows: positive antinuclear
antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive
anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody

- At both screening and Day 1, moderate to severe active SLE, defined as meeting all of
the following unless indicated otherwise: Systemic Lupus Erythematosus Disease
Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K
score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0
(out of 3), and currently receiving at least one standard oral treatment for SLE

- If on oral corticosteroids (OCS), the dose must be equivalent)

- Stable doses of anti-malarial or immunosuppressive therapies

- Participants must be willing to avoid pregnancy

Exclusion Criteria:

- Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR)
in a first morning void urine sample

- Active proliferative lupus nephritis (as assessed by the investigator) or histological
evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in
the 6 months prior to screening (or during the screening period)

- History of having required hemodialysis or high dose corticosteroids (>100 mg/d)
prednisone or equivalent) for the management of lupus renal disease within 90 days of
Day 1

- Neuropsychiatric or central nervous system lupus manifestations

- Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter
per minute (mL/min) or on chronic renal replacement therapy

- History of receiving a solid organ transplant

- Evidence of active, latent, or inadequately treated infection with Mycobacterium
tuberculosis (TB)

- Significant and uncontrolled medical disease within the 12 weeks prior to screening in
any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine,
metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the
investigator's or Sponsor's opinion, would preclude study participation

- History of cancer, including hematological malignancy and solid tumors, within 10
years of screening

- Need for systemic anticoagulation with warfarin, other oral or injectable
anticoagulants, or anti-platelet agents

- Evidence of chronic and/or active hepatitis B or C
We found this trial at
31
sites
Albuquerque, New Mexico
1184
mi
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Albuquerque, NM
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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...
2072
mi
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
2329
mi
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Chapel Hill, NC
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Austin, Texas 78745
1770
mi
from 98109
Austin, TX
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Baton Rouge, Louisiana 70809
2036
mi
from 98109
Baton Rouge, LA
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8750 Wilshire Boulevard
Beverly Hills, California 90211
958
mi
from 98109
Beverly Hills, CA
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Boca Raton, Florida
2708
mi
from 98109
Boca Raton, FL
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
2485
mi
from 98109
Boston, MA
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Brandon, Florida 33511
2536
mi
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Brandon, FL
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7131
mi
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Buenos Aires,
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80 New York 310
Canton, New York 13617
2234
mi
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Canton, NY
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1966
mi
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Cincinnati, OH
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2008
mi
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Columbus, OH
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1504
mi
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Fairway, KS
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1890
mi
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Houston, TX
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4825 Almeda Road
Houston, Texas 77004
1892
mi
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Houston, TX
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Huntington Beach, California 92646
991
mi
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Huntington Beach, CA
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Idaho Falls, Idaho 83404
577
mi
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Idaho Falls, ID
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10861 Cherry Street
Los Alamitos, California 90720
980
mi
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Los Alamitos, CA
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2413
mi
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Manhasset, NY
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Modesto, California 95355
691
mi
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Modesto, CA
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1890
mi
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Monroe, LA
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
2402
mi
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New York, NY
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Orlando, Florida 32804
2544
mi
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Orlando, FL
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10208 Cerny Street
Raleigh, North Carolina 27617
2349
mi
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Raleigh, NC
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1340 Wonder World Drive
San Marcos, Texas 78666
1785
mi
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San Marcos, TX
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5115 North Armenia Avenue
Tampa, Florida 33603
2523
mi
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Tampa, FL
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3500 Lomita Boulevard
Torrance, California 90505
977
mi
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Torrance, CA
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Trumbull, Connecticut 06611
2421
mi
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Trumbull, CT
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1501 North Campbell Avenue
Tucson, Arizona 85724
1219
mi
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Tucson, AZ
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1435
mi
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Wichita, KS
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