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

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Antibodies, Monoclonal

Criteria

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.

• 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.