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)
NCT ID: NCT03724916
Last Updated: 2024-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2018-11-26
2021-11-04
Brief Summary
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Detailed Description
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The study will enroll approximately 24 participants across 3 sequentially enrolling cohorts. Each cohort will enroll 8 participants, where 6 participants will be assigned to TAK-079 injection, and 2 participants will be assigned to Placebo. Participants will receive TAK-079 or matching placebo in combination with principal investigator directed background therapy for SLE.
This multi-center trial will be conducted in the United States. Participants will make multiple visits to the clinic, and will be followed up for the safety assessment for the additional 12 weeks up to Week 24 after receiving their last dose of study drug. Based on the clinical assessments, participants may complete or may advance to long-term safety follow up period for an additional 12-week safety monitoring period up to Week 36.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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Pooled Placebo
TAK-079 placebo-matching injection, subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks. Placebo data will be pooled across all the dose levels.
TAK-079 Placebo
TAK-079 placebo-matching subcutaneous injection.
TAK-079 45 mg
TAK-079 45 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
TAK-079
TAK-079 subcutaneous injection.
TAK-079 90 mg
TAK-079 90 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
TAK-079
TAK-079 subcutaneous injection.
TAK-079 135 mg
TAK-079 135 mg injection subcutaneously, once every 3 weeks in combination with principal investigator-directed background therapy for SLE for up to 12 weeks.
TAK-079
TAK-079 subcutaneous injection.
Interventions
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TAK-079
TAK-079 subcutaneous injection.
TAK-079 Placebo
TAK-079 placebo-matching subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
2. The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 6.
3. The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies.
Exclusion Criteria
2. 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.
3. The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).
18 Years
75 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1220-2497
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-079-2001
Identifier Type: -
Identifier Source: org_study_id
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