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

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.

Study Overview

• Status: Terminated
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: Tabalumab Auto-Injector; Drug: Tabalumab Prefilled Syringe

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 301-721
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Incheon, Korea, Republic of, 405-760
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Seoul, Korea, Republic of, 143-729
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Office: Perez de Jesus, Amarylis
  • Carolina, Puerto Rico, 00983
    • Ramon L. Ortega Colon
  • San Juan, Puerto Rico, 00909
    • GCM Medical Group PSC
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • Santurce, Puerto Rico, 00909
    • Latin Clinical Trial Center
• United States
  • California
    • Covina, California, United States, 91723
      • Medvin Clinical Research
    • El Cajon, California, United States, 92020
      • Triwest Research Associates
    • Long Beach, California, United States, 90808
      • ProHealth Partners Medical Group
    • Los Angeles, California, United States, 90048
      • Wallace Rheumatic Study Center
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
    • Upland, California, United States, 91786
      • Inlande Rheumatology Clinical Trials
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Center
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • New England Research Associates
  • Florida
    • Miami, Florida, United States, 33175
      • New Horizon Research Center
    • Miami, Florida, United States, 33136
      • Advanced Pharma Clinical Research
    • Palm Harbor, Florida, United States, 34684
      • Arthritis Research of Florida
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • The Arthritis & Diabetes Clinic Inc.
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • West Michigan Rheumatology
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Clayton Medical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Physician Research Collaboration, LLC
    • Omaha, Nebraska, United States, 68114
      • Westroads Clinical Research-Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • (AOA) Arthritis & Osteoporosis Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Box Arthritis & Rheumatology of the Carolinas, PLLC
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Raleigh, North Carolina, United States, 27617
      • Shanahan Rheumatology & Immunotherapy
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Oklahoma Arthritis Center
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLP
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Low Country Research Center
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc.
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest Rheumatology
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Mountain State Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: LY2127399

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose	Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose	Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight	Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight	Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Number of Participants Reporting Incomplete Tabalumab Dose Administration	Participants reporting incomplete dose administration from the study drug administration log.	Week 0 through Week 12
Number of Participants Developing Anti-Tabalumab Antibodies	Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)*100.	Week 0 through Week 12
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score	The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from "Strongly Disagree" as 1 to "Strongly Agree" as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.	Week 0, Week 4 and Week 8
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications	Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications	Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.	Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: 15193; H9B-MC-BCEI (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No