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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Venetoclax

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.