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

Primary Purpose

Lupus Erythematosus, Systemic

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tabalumab Auto-Injector
Tabalumab Prefilled Syringe
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Medvin Clinical Research
  • TriWest Research Associates
  • ProHealth Partners Medical Group
  • Wallace Rheumatic Study Center
  • Desert Medical Advances
  • Inlande Rheumatology Clinical Trials
  • Denver Arthritis Center
  • New England Research Associates
  • Advanced Pharma Clinical Research
  • New Horizon Research Center
  • Arthritis Research of Florida
  • Clinical Research of West Florida, Inc.
  • Indiana University Health
  • The Arthritis & Diabetes Clinic Inc.
  • West Michigan Rheumatology
  • Clayton Medical Research
  • Physician Research Collaboration, LLC
  • Westroads Clinical Research-Omaha
  • Innovative Health Research
  • (AOA) Arthritis & Osteoporosis Associates
  • Albuquerque Clinical Trials
  • The Feinstein Institute for Medical Research
  • Box Arthritis & Rheumatology of the Carolinas, PLLC
  • PharmQuest
  • Shanahan Rheumatology & Immunotherapy
  • PMG Research of Salisbury
  • Paramount Medical Research
  • Oklahoma Arthritis Center
  • Altoona Center for Clinical Research
  • Clinical Research Center of Reading, LLP
  • Low Country Research Center
  • Tekton Research, Inc.
  • Sun Research Institute
  • Virginia Clinical Research
  • Arthritis Northwest Rheumatology
  • Mountain State Clinical Research
  • 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.
  • 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.
  • 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.
  • Office: Perez de Jesus, Amarylis
  • Ramon L. Ortega Colon
  • GCM Medical Group PSC
  • Mindful Medical Research
  • Latin Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Participants reporting incomplete dose administration from the study drug administration log.
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.
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.
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.
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.

Full Information

First Posted
January 17, 2014
Last Updated
May 16, 2018
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02041091
Brief Title
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Official Title
Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tabalumab Auto-Injector
Arm Type
Experimental
Arm 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.
Arm Title
Tabalumab Prefilled Syringe
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tabalumab Auto-Injector
Other Intervention Name(s)
LY2127399
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Tabalumab Prefilled Syringe
Other Intervention Name(s)
LY2127399
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
Description
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.
Time Frame
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Title
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
Description
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.
Time Frame
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 Measure Information:
Title
Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
Description
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.
Time Frame
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Title
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
Description
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.
Time Frame
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Title
Number of Participants Reporting Incomplete Tabalumab Dose Administration
Description
Participants reporting incomplete dose administration from the study drug administration log.
Time Frame
Week 0 through Week 12
Title
Number of Participants Developing Anti-Tabalumab Antibodies
Description
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.
Time Frame
Week 0 through Week 12
Title
Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
Description
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.
Time Frame
Week 0, Week 4 and Week 8
Title
Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
Description
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.
Time Frame
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Title
Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
Description
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.
Time Frame
Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
TriWest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
ProHealth Partners Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Inlande Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Advanced Pharma Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Arthritis Research of Florida
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Arthritis & Diabetes Clinic Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
West Michigan Rheumatology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Clayton Medical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Westroads Clinical Research-Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
(AOA) Arthritis & Osteoporosis Associates
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Box Arthritis & Rheumatology of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Shanahan Rheumatology & Immunotherapy
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Paramount Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oklahoma Arthritis Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Low Country Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Arthritis Northwest Rheumatology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Mountain State Clinical Research
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
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.
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
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.
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
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.
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Office: Perez de Jesus, Amarylis
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Ramon L. Ortega Colon
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
Facility Name
GCM Medical Group PSC
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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