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 |
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.
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.
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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