ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02041091
Recruitment Status : Terminated (Lack of efficacy)
First Posted : January 20, 2014
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Tabalumab Auto-Injector Drug: Tabalumab Prefilled Syringe Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tabalumab Auto-Injector
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.
Drug: Tabalumab Auto-Injector
Administered SC
Other Name: LY2127399
Experimental: Tabalumab Prefilled Syringe
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.
Drug: Tabalumab Prefilled Syringe
Administered SC
Other Name: LY2127399



Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose [ Time Frame: Day 0 through 14 ]
  2. Pharmacokinetics (PK): Area Under the Concentration Time Curve from Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose [ Time Frame: Day 0 through 14 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ]
  2. Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ]
  3. Percentage of Participants Reporting Incomplete Tabalumab Dose Administration [ Time Frame: Week 0 through Week 12 ]
  4. Number of Participants Developing Anti-Tabalumab Antibodies [ Time Frame: Week 0 through Week 12 ]
  5. Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score [ Time Frame: Week 0, Week 4 and Week 8 ]
  6. Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ]
  7. Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041091


  Show 44 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02041091     History of Changes
Other Study ID Numbers: 15193
H9B-MC-BCEI ( Other Identifier: Eli Lilly and Company )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs