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)
Public ClinicalTrials.gov record NCT03724916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03724916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 23 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2018 (Actual)
- Primary completion
- Nov 4, 2021 (Actual)
- Completion
- Nov 4, 2021 (Actual)
- Last update posted
- Mar 29, 2024
2018 – 2021
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| ACRC Studies | Poway | California | 92064 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Clinical Research of West Florida - Clearwater | Clearwater | Florida | 33765 | — |
| CRIA Research | Fort Lauderdale | Florida | 33309 | — |
| Millennium Research | Ormond Beach | Florida | 32174 | — |
| North Georgia Rheumatology Group-Duluth | Lawrenceville | Georgia | 30046 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Northwell Health | Great Neck | New York | 11021 | — |
| State University of New York Upstate Medical Center (SUNY) | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Accurate Clinical Research | Houston | Texas | 77034 | — |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | — |
| Arthritis Northwest Rheumatology | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03724916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2024 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03724916 live on ClinicalTrials.gov.