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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Lupus Erythematosus

Treatments: Drug: ABT-199; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01686555

2013-000328-33 (EudraCT Number)

M13-093

Details and patient eligibility

About

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

Full description

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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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97 participants in 2 patient groups

Single Dose

Experimental group

Description:

Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).

Treatment:

Drug: ABT-199

Other: Placebo

Multiple Dose

Experimental group

Description:

Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)

Treatment:

Drug: ABT-199

Other: Placebo