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A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus

Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus

NCT02041091•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of Lupus.
•Able and willing to have blood drawn for PK sampling.

Exclusion Criteria

•Have severe active lupus nephritis.
•Have severe active central nervous system (CNS) or peripheral neurologic disease or other severe neurologic involvement requiring treatment within approximately 3 months prior to screening.
•Have received high dose corticosteroid within approximately 1 month prior to baseline.
•Have initiated or adjusted treatment with immunosuppressant drugs within approximately 1 month prior to baseline.
•Have received plasmapheresis within approximately 3 months prior to baseline.
•Have previously received approved or experimental B cell targeted therapies within the last year.
•Have received any biologic or non-biologic therapy within approximately 3 months or 5 half-lives (whichever is longer).
•Have a history of severe reaction to any biologic therapy.
•Have an active or recent infection within approximately 1 month prior to Week 0.
•Have had a serious infection within approximately 3 month or serious bone/joint infection within approximately 6 months prior to baseline.
+3 more criteria

Locations (44)

Medvin Clinical Research

Covina, California, United States

TriWest Research Associates

El Cajon, California, United States

ProHealth Partners Medical Group

Long Beach, California, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

Desert Medical Advances

Palm Desert, California, United States

Inlande Rheumatology Clinical Trials

Upland, California, United States

Denver Arthritis Center

Denver, Colorado, United States

New England Research Associates

Trumbull, Connecticut, United States

Advanced Pharma Clinical Research

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

November 1, 2015

Last Updated

June 15, 2018

Enrollment

226

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

Tabalumab Auto-Injector

DRUG

Tabalumab Prefilled Syringe

DRUG

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

View study

RECRUITINGPHASE3

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

NCT07438496

Lupus Erythematosus, Systemic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases