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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01686555
• Date of registration: 13/09/2012
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
• Scientific title: Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: November 2012
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01686555
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany, Mexico, Puerto Rico, United States

Contacts

• Name: Peng Lu, MD
• Affiliation: AbbVie

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Lupus Erythematosus

Intervention(s)

Drug: ABT-199

Other: Placebo

Primary Outcome(s)

Number of participants with Adverse Events [Time Frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199]

Electrocardiogram (ECG) Measurements [Time Frame: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199]

Maximum observed serum concentration (Cmax) of ABT-199 [Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199]

Physical Exam including vital signs [Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199]

Clinical Lab Testing [Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199]

The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199 [Time Frame: For 72 hours after a single dose of ABT-199]

Time to Cmax (Tmax) of ABT-199 [Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199]

The area under the time curve (AUC) of ABT-199 [Time Frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199]

Secondary Outcome(s)

Measurement of lymphocyte depletion and recovery [Time Frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199]

Secondary ID(s)

2013-000328-33

M13-093

Source(s) of Monetary Support

Please refer to primary and secondary sponsors