- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01686555
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
November 16, 2017 updated by: AbbVie (prior sponsor, Abbott)
Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study.
Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate.
Subjects will be randomized to receive either ABT-199 or placebo.
Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
- Site Reference ID/Investigator# 107896
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Distrito Federal, Mexico, CP 14050
- Site Reference ID/Investigator# 116395
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Monterrey, Mexico, C.P. 64000
- Site Reference ID/Investigator# 112555
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San Juan, Puerto Rico, 00909-3004
- Site Reference ID/Investigator# 132009
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Florida
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Clearwater, Florida, United States, 33765
- Site Reference ID/Investigator# 89694
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DeBary, Florida, United States, 32713
- Site Reference ID/Investigator# 131720
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Miami, Florida, United States, 33136
- Site Reference ID/Investigator# 118637
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Miami Lakes, Florida, United States, 33016
- Site Reference ID/Investigator# 124116
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Orlando, Florida, United States, 32806
- Site Reference ID/Investigator# 89693
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Kansas
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Overland Park, Kansas, United States, 66212
- Site Reference ID/Investigator# 78256
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Minnesota
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Rochester, Minnesota, United States, 55905
- Site Reference ID/Investigator# 129826
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New York
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Manhasset, New York, United States, 11030
- Site Reference ID/Investigator# 89773
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Site Reference ID/Investigator# 78254
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Texas
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Dallas, Texas, United States, 75231
- Site Reference ID/Investigator# 123335
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Dallas, Texas, United States, 75231
- Site Reference ID/Investigator# 78253
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus for at least 6 months.
- 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:
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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).
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Tablet
Tablet
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Experimental: 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)
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Tablet
Tablet
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of participants with Adverse Events
Time Frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Collect all adverse events at each visit
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From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Physical Exam including vital signs
Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Blood pressure, heart rate and body temperature
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Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Clinical Lab Testing
Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Hematology, Chemistry, and Urinalysis
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Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Electrocardiogram (ECG) Measurements
Time Frame: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199
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ECGs done in triplicate
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For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199
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Maximum observed serum concentration (Cmax) of ABT-199
Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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Cmax
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For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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Time to Cmax (Tmax) of ABT-199
Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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Time to Cmax
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For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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The area under the time curve (AUC) of ABT-199
Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199
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For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
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The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
Time Frame: For 72 hours after a single dose of ABT-199
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The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
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For 72 hours after a single dose of ABT-199
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Measurement of lymphocyte depletion and recovery
Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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explore pharmacokinetic/pharmacodynamic relationship
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Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Peng Lu, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
September 13, 2012
First Submitted That Met QC Criteria
September 13, 2012
First Posted (Estimate)
September 18, 2012
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-093
- 2013-000328-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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