A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

Study Identifier
M13-093
CT.gov Identifier
NCT01686555
EudraCT Identifier
2013-000328-33
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Lupus (Systemic Lupus Erythematosus (SLE))
    • Study Drug
  • ABT-199
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 89694
    Clearwater, Florida, United States, 33765
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 131720
    DeBary, Florida, United States, 32713
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 118637
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 124116
    Miami Lakes, Florida, United States, 33016
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 89693
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 78256
    Overland Park, Kansas, United States, 66212
    Status
    Not applicable
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