A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT01686555
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
97 participants
INTERVENTIONAL
2012-11-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Single Dose
Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).
ABT-199
Tablet
Placebo
Tablet
Multiple Dose
Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)
ABT-199
Tablet
Placebo
Tablet
Interventions
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ABT-199
Tablet
Placebo
Tablet
Eligibility Criteria
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Inclusion Criteria
* Documentation of at least one of the following: ANA titer \>= 1:160 or positive anti-dsDNA antibodies.
* Stable systemic lupus erythematosus medication regimen.
* Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria
* Drug-induced or highly active systemic lupus erythematosus.
* Significant autoimmune disease other than lupus.
* Significant, uncontrolled or unstable disease in any organ.
18 Years
65 Years
FEMALE
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Peng Lu, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 89694
Clearwater, Florida, United States
Site Reference ID/Investigator# 131720
DeBary, Florida, United States
Site Reference ID/Investigator# 118637
Miami, Florida, United States
Site Reference ID/Investigator# 124116
Miami Lakes, Florida, United States
Site Reference ID/Investigator# 89693
Orlando, Florida, United States
Site Reference ID/Investigator# 78256
Overland Park, Kansas, United States
Site Reference ID/Investigator# 129826
Rochester, Minnesota, United States
Site Reference ID/Investigator# 89773
Manhasset, New York, United States
Site Reference ID/Investigator# 78254
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 123335
Dallas, Texas, United States
Site Reference ID/Investigator# 78253
Dallas, Texas, United States
Site Reference ID/Investigator# 107896
Berlin, , Germany
Site Reference ID/Investigator# 116395
Distrito Federal, , Mexico
Site Reference ID/Investigator# 112555
Monterrey, , Mexico
Site Reference ID/Investigator# 132009
San Juan, , Puerto Rico
Countries
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References
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Lu P, Fleischmann R, Curtis C, Ignatenko S, Clarke SH, Desai M, Wong SL, Grebe KM, Black K, Zeng J, Stolzenbach J, Medema JK. Safety and pharmacodynamics of venetoclax (ABT-199) in a randomized single and multiple ascending dose study in women with systemic lupus erythematosus. Lupus. 2018 Feb;27(2):290-302. doi: 10.1177/0961203317719334. Epub 2017 Jul 10.
Nader A, Minocha M, Othman AA. Exposure-Response Analyses of the Effects of Venetoclax, a Selective BCL-2 Inhibitor, on B-Lymphocyte and Total Lymphocyte Counts in Women with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2020 Mar;59(3):335-347. doi: 10.1007/s40262-019-00818-5.
Minocha M, Zeng J, Medema JK, Othman AA. Pharmacokinetics of the B-Cell Lymphoma 2 (Bcl-2) Inhibitor Venetoclax in Female Subjects with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2018 Sep;57(9):1185-1198. doi: 10.1007/s40262-017-0625-2.
Other Identifiers
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2013-000328-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-093
Identifier Type: -
Identifier Source: org_study_id