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

Lilly

Status and phase: Terminated; Phase 3

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Tabalumab Auto-Injector; Drug: Tabalumab Prefilled Syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02041091

H9B-MC-BCEI (Other Identifier)

15193

Details and patient eligibility

About

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.

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Tabalumab Auto-Injector

Experimental group

Description:

Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.

Treatment:

Drug: Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Experimental group

Description:

Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.

Treatment:

Drug: Tabalumab Prefilled Syringe