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)

ClinicalTrials.gov ID: NCT03724916

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.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 5:15 AM EDT

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

Study identification

NCT ID: NCT03724916
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Millennium Pharmaceuticals, Inc.; Industry
Enrollment: 23 participants

Conditions and interventions

Conditions

Interventions

TAK-079 Drug
TAK-079 Placebo Drug

Drug

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 25, 2018
Primary completion: Nov 3, 2021
Completion: Nov 3, 2021
Last update posted: Mar 28, 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 28, 2024 · Synced Jul 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03724916 live on ClinicalTrials.gov.

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