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

Completed · Phase 1 · Has a placebo group

Conditions studied: Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT01686555

Run by

AbbVie (prior sponsor, Abbott)

People needed

97

Starts

2012-11-01

Expected to finish

2015-06-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Male.
• Drug-induced or highly active systemic lupus erythematosus.
• Significant autoimmune disease other than lupus.
• Significant, uncontrolled or unstable disease in any organ.

Where it is running

• Site Reference ID/Investigator# 89694 — Clearwater, Florida, United States
• Site Reference ID/Investigator# 131720 — DeBary, Florida, United States
• Site Reference ID/Investigator# 118637 — Miami, Florida, United States
• Site Reference ID/Investigator# 124116 — Miami Lakes, Florida, United States
• Site Reference ID/Investigator# 89693 — Orlando, Florida, United States
• Site Reference ID/Investigator# 78256 — Overland Park, Kansas, United States
• Site Reference ID/Investigator# 129826 — Rochester, Minnesota, United States
• Site Reference ID/Investigator# 89773 — Manhasset, New York, United States
• Site Reference ID/Investigator# 78254 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 123335 — Dallas, Texas, United States
• Site Reference ID/Investigator# 78253 — Dallas, Texas, United States
• Site Reference ID/Investigator# 107896 — Berlin, Germany
• Site Reference ID/Investigator# 116395 — Distrito Federal, Mexico
• Site Reference ID/Investigator# 112555 — Monterrey, Mexico
• Site Reference ID/Investigator# 132009 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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