Upstate Active Clinical Trials

Study Title:

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics
of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe
Systemic Lupus Erythematosus. TAK-079-2001

What is the purpose of the study?

Purpose of this study
• Test the safety and tolerability of the research study drug, TAK-079
• Obtain information on the amount of TAK-079 in your blood after taking single and/or doses of the study drug
• Obtain information on the correct dose of the research drug, TAK-079
• Obtain information how your body reacts on the research drug, TAK-079
• Test the activity of the research drug, TAK-079 against your disease
• Obtain information on specific chemical “markers” (also known as biomarkers) that can be found in blood and bone marrow samples that may allow doctors to identify patients who are more likely to respond or to develop side effects to TAK-079.
• The total amount of time you may be involved in the study is up to 36 Weeks.

Upstate Institutional Review Board (IRB) Number:

1422339

Study/Protocol ID:

TAK-079-2001

Study Phase:

N/A

Patient Age Group:

Adults

Principal Investigator:

Andras Perl, MD, PhD

Who can I contact for more information?

Name: Joanne M Chilton, CCRP
Phone: 315-464-8240
Email: chiltonj@upstate.edu

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