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

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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)

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

Trial contacts and locations

44

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Data sourced from clinicaltrials.gov

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