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
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Chapel Hill, North Carolina 27599
(919) 962-2211
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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Albuquerque, New Mexico
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Austin, Texas 78745
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Baton Rouge, Louisiana 70809
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8750 Wilshire Boulevard
Beverly Hills, California 90211
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Boca Raton, Florida
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
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Brandon, Florida 33511
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80 New York 310
Canton, New York 13617
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4825 Almeda Road
Houston, Texas 77004
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Huntington Beach, California 92646
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Idaho Falls, Idaho 83404
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10861 Cherry Street
Los Alamitos, California 90720
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Modesto, California 95355
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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...
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Orlando, Florida 32804
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10208 Cerny Street
Raleigh, North Carolina 27617
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1340 Wonder World Drive
San Marcos, Texas 78666
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5115 North Armenia Avenue
Tampa, Florida 33603
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Torrance, California 90505
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Trumbull, Connecticut 06611
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1501 North Campbell Avenue
Tucson, Arizona 85724
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