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



Status:Completed
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:11/22/2017
Start Date:November 2012
End Date:June 2015

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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.

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.

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.
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