Trial record 10 of 11 for:    Lupus AND Los Angeles | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02041091
First received: January 17, 2014
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Lupus Erythematosus, Systemic
Drug: Tabalumab Auto-Injector
Drug: Tabalumab Prefilled Syringe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose [ Time Frame: Day 0 through 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ] [ Designated as safety issue: No ]
  • Percentage of Participants Reporting Incomplete Tabalumab Dose Administration [ Time Frame: Week 0 through Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Developing Anti-Tabalumab Antibodies [ Time Frame: Week 0 through Week 12 ] [ Designated as safety issue: Yes ]
  • Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score [ Time Frame: Week 0, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications [ Time Frame: Day 0 through Day 14 and Day 28 through Day 61 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: January 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041091

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 45 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02041091     History of Changes
Other Study ID Numbers: 15193, H9B-MC-BCEI
Study First Received: January 17, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Mexico: Ministry of Health

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014