A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)
NCT01686555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97
Last updated 2017-11-20
Summary
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
Conditions
- Lupus Erythematosus
Interventions
- DRUG
-
ABT-199
Tablet
- OTHER
-
Placebo
Tablet
Sponsors & Collaborators
-
AbbVie (prior sponsor, Abbott)
lead INDUSTRY
Principal Investigators
-
Peng Lu, MD · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
Countries
- United States
- Germany
- Mexico
- Puerto Rico
Study Locations
More Related Trials
-
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
NCT01689025 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
NCT05984251 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
NCT03724916 ·Status: COMPLETED ·Phase: PHASE1
-
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
NCT05843643 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
NCT02331810 ·Status: WITHDRAWN ·Phase: PHASE1
-
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
NCT02270957 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus
NCT00482989 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)
NCT06977724 ·Status: RECRUITING ·Phase: PHASE1
-
Subgrouping SLE - a New Approach to Understand the Pathogenesis and Improve Treatment
NCT07102030 ·Status: RECRUITING
-
Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE
NCT01702038 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
NCT06897930 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
NCT00035308 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT01196091 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT00137969 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
NCT06335979 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
NCT04186871 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis.
NCT06916806 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
NCT00113971 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
NCT03978520 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
NCT00299819 ·Status: COMPLETED ·Phase: PHASE1
-
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
NCT06333483 ·Status: RECRUITING ·Phase: PHASE1
-
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
NCT01777256 ·Status: TERMINATED ·Phase: PHASE2
-
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
NCT02554019 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus
NCT06429800 ·Status: WITHDRAWN ·Phase: PHASE1
-
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
NCT03771885 ·Status: WITHDRAWN ·Phase: PHASE1