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

Stopped early · Phase 3

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT02041091

Run by

Eli Lilly and Company

People needed

226

Starts

2014-01-01

Expected to finish

2015-11-01

Last updated by the study team

2018-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Have evidence of or test positive for active hepatitis B or are positive for hepatitis C or human immunodeficiency virus (HIV).
• Have evidence of active or latent tuberculosis.
• Have significant hematological abnormalities.

Where it is running

• 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
• Arthritis Research of Florida — Palm Harbor, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Indiana University Health — Indianapolis, Indiana, United States
• The Arthritis & Diabetes Clinic Inc. — Monroe, Louisiana, United States
• West Michigan Rheumatology — Grand Rapids, Michigan, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Westroads Clinical Research-Omaha — Omaha, Nebraska, United States
• Innovative Health Research — Las Vegas, Nevada, United States
• (AOA) Arthritis & Osteoporosis Associates — Freehold, New Jersey, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• The Feinstein Institute for Medical Research — Manhasset, New York, United States
• Box Arthritis & Rheumatology of the Carolinas, PLLC — Charlotte, North Carolina, United States
• PharmQuest — Greensboro, North Carolina, United States
• Shanahan Rheumatology & Immunotherapy — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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