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)

NCT03724916 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-079-2001U1111-1220-2497
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus; Lupus Erythematosus, Systemic

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

  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.

  From the study start to end of the study (up to Week 36)

• Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)

  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.

  From the study start up to end of the study (up to Week 36)

• Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation

  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.

  From the study start up to end of the study (up to Week 36)

Secondary Outcomes (6)

• Cmax: Maximum Observed Plasma Concentration for TAK-079

  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

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079

  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.

• Number of Participants With Change From Baseline In Immune Cell Subsets

  Baseline up to Day 85 (End of Treatment [EOT])

• Number of Participants With Change From Baseline in Immune Cell Subsets Determined Based on Receptor Occupancy

  Baseline up to Day 85 (EOT)

• Change From Baseline in Cytokines Level

  Baseline up to Day 85

Study Arms (4)

Pooled Placebo

PLACEBO COMPARATOR

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.

Drug: TAK-079 Placebo

TAK-079 45 mg

EXPERIMENTAL

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.

Drug: TAK-079

TAK-079 90 mg

EXPERIMENTAL

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.

Drug: TAK-079

TAK-079 135 mg

EXPERIMENTAL

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.

Drug: TAK-079

Interventions

TAK-079 DRUG

TAK-079 subcutaneous injection.

TAK-079 135 mg; TAK-079 45 mg; TAK-079 90 mg

TAK-079 Placebo DRUG

TAK-079 placebo-matching subcutaneous injection.

Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (19)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

ACRC Studies

Poway, California, 92064, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Clinical Research of West Florida - Clearwater

Clearwater, Florida, 33765, United States

Location

CRIA Research

Fort Lauderdale, Florida, 33309, United States

Location

Millennium Research

Ormond Beach, Florida, 32174, United States

Location

North Georgia Rheumatology Group-Duluth

Lawrenceville, Georgia, 30046, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

State University of New York Upstate Medical Center (SUNY)

Syracuse, New York, 13210, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Accurate Clinical Research

Houston, Texas, 77034, United States

Location

Southwest Rheumatology Research, LLC

Mesquite, Texas, 75150, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Contact
• Organization: Takeda

medinfoUS@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 30, 2018
• Study Start: November 26, 2018
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (19)