A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Status: | Terminated |
---|---|
Conditions: | Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/17/2018 |
Start Date: | January 2014 |
End Date: | November 2015 |
Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
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.
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.
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.
We found this trial at
37
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