- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724916
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)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
TAK-079 is being tested in a study population with moderate to severe SLE. This study will evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with stable SLE background therapy.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Alabama
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Anniston, Alabama, United States, 36207
- Pinnacle Research Group, LLC
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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California
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La Jolla, California, United States, 92037
- University of California San Diego
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Poway, California, United States, 92064
- ACRC Studies
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Florida
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Clearwater, Florida, United States, 33765
- Clinical Research of West Florida - Clearwater
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Fort Lauderdale, Florida, United States, 33309
- CRIA Research
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Ormond Beach, Florida, United States, 32174
- Millennium Research
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Georgia
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Lawrenceville, Georgia, United States, 30046
- North Georgia Rheumatology Group-Duluth
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Institute of Arthritis Research
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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New York
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Great Neck, New York, United States, 11021
- Northwell Health
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical Center (SUNY)
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Texas
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Houston, Texas, United States, 77034
- Accurate Clinical Research
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Mesquite, Texas, United States, 75150
- Southwest Rheumatology Research, LLC
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Washington
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Spokane, Washington, United States, 99204
- Arthritis Northwest Rheumatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: 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.
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TAK-079 placebo-matching subcutaneous injection.
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Experimental: 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.
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TAK-079 subcutaneous injection.
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Experimental: 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.
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TAK-079 subcutaneous injection.
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Experimental: 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.
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TAK-079 subcutaneous injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time Frame: From the study start to end of the study (up to Week 36)
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An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
A TEAE is defined as an AE with an onset that occurs after receiving study drug.
An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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From the study start to end of the study (up to Week 36)
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Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
Time Frame: From the study start up to end of the study (up to Week 36)
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The severity of TEAEs will be graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 definitions of Grade 1 through Grade 5. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4 Life-threatening consequences; urgent intervention indicated.
Grade 5 Death related to AE.
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From the study start up to end of the study (up to Week 36)
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Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation
Time Frame: From the study start up to end of the study (up to Week 36)
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
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From the study start up to end of the study (up to Week 36)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax: Maximum Observed Plasma Concentration for TAK-079
Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose
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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose.
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Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose.
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Number of Participants With Change From Baseline In Immune Cell Subsets
Time Frame: Baseline up to Day 85 (End of Treatment [EOT])
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Immune cell subsets included plasma cells, plasma blast (PBs), natural killer (NK) cells, B cells, T cells, monocytes, and total lymphocytes.
The concentration of each plasma subset cell type is measured at baseline and post-baseline timepoints and the number of participants who had change in the concentration of each plasma subset cells from baseline were evaluated and reported in this outcome measure.
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Baseline up to Day 85 (End of Treatment [EOT])
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Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy
Time Frame: Baseline up to Day 85 (EOT)
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Receptor occupancy was evaluated for plasma cells, PBs, NK cells, B cells, T cells, and monocytes.
The concentration of cells expressing CD38+ and those not expressing the same is correlated and used to determine receptor occupancy.
The receptor occupancy of these cells was determined at baseline and post-baseline timepoints.
The number of participants who had change in the receptor occupancy of these cells from baseline were evaluated and reported in this outcome measure.
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Baseline up to Day 85 (EOT)
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Change From Baseline in Cytokines Level
Time Frame: Baseline up to Day 85
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Baseline up to Day 85
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Number of Participants With Positive Anti-drug Antibodies
Time Frame: Baseline up to Day 85 (EOT)
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Baseline up to Day 85 (EOT)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Millennium Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-079-2001
- U1111-1220-2497 (Other Identifier: World Health Organization)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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