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)

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus, Lupus Erythematosus, Systemic

In brief

The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.

Key facts

Study ID

NCT03724916

Run by

Millennium Pharmaceuticals, Inc.

People needed

23

Starts

2018-11-26

Expected to finish

2021-11-04

Last updated by the study team

2024-03-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant been diagnosed with SLE as defined by either the 2012 Systemic Lupus International Collaborating Clinics or the American College of Rheumatology diagnostic criteria.
• The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (>=) 6.
• The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies.

You may not qualify if…

• The participant had an opportunistic infection less than or equal to (<=)12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
• The participant currently has, or recently had, an acute or chronic infection requiring one or more of the following interventions: Hospitalization <=30 days before the screening visit. - Administered parenteral (IV or intramuscular) antibacterial, antiviral, antifungal, or antiparasitic agents <=30 days before the screening visit.
• The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California San Diego — La Jolla, California, United States
• ACRC Studies — Poway, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Clinical Research of West Florida - Clearwater — Clearwater, Florida, United States
• CRIA Research — Fort Lauderdale, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• North Georgia Rheumatology Group-Duluth — Lawrenceville, Georgia, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Northwell Health — Great Neck, New York, United States
• State University of New York Upstate Medical Center (SUNY) — Syracuse, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Accurate Clinical Research — Houston, Texas, United States
• Southwest Rheumatology Research, LLC — Mesquite, Texas, United States
• Arthritis Northwest Rheumatology — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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