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

Lupus Erythematosus, Systemic Clinical Trial

Official title:

Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02041091
• Other study ID #: 15193
• Secondary ID: H9B-MC-BCEI
• Status: Terminated
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 226
• Est. completion date: November 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Tabalumab Auto-Injector
Administered SC
• Tabalumab Prefilled Syringe
Administered SC

Locations

Country	Name	City	State
Korea, Republic of	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.	Daejeon
Korea, Republic of	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	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
Puerto Rico	Office: Perez de Jesus, Amarylis	Caguas
Puerto Rico	Ramon L. Ortega Colon	Carolina
Puerto Rico	GCM Medical Group PSC	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Puerto Rico	Latin Clinical Trial Center	Santurce
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Tekton Research, Inc.	Austin	Texas
United States	Box Arthritis & Rheumatology of the Carolinas, PLLC	Charlotte	North Carolina
United States	Mountain State Clinical Research	Clarksburg	West Virginia
United States	Medvin Clinical Research	Covina	California
United States	Denver Arthritis Center	Denver	Colorado
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Oklahoma Arthritis Center	Edmond	Oklahoma
United States	TriWest Research Associates	El Cajon	California
United States	(AOA) Arthritis & Osteoporosis Associates	Freehold	New Jersey
United States	West Michigan Rheumatology	Grand Rapids	Michigan
United States	PharmQuest	Greensboro	North Carolina
United States	Indiana University Health	Indianapolis	Indiana
United States	Innovative Health Research	Las Vegas	Nevada
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	ProHealth Partners Medical Group	Long Beach	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Advanced Pharma Clinical Research	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	The Arthritis & Diabetes Clinic Inc.	Monroe	Louisiana
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Low Country Research Center	North Charleston	South Carolina
United States	Westroads Clinical Research-Omaha	Omaha	Nebraska
United States	Desert Medical Advances	Palm Desert	California
United States	Arthritis Research of Florida	Palm Harbor	Florida
United States	Shanahan Rheumatology & Immunotherapy	Raleigh	North Carolina
United States	Clayton Medical Research	Saint Louis	Missouri
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Sun Research Institute	San Antonio	Texas
United States	Arthritis Northwest Rheumatology	Spokane	Washington
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	New England Research Associates	Trumbull	Connecticut
United States	Inlande Rheumatology Clinical Trials	Upland	California
United States	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of Participants Reporting Incomplete Tabalumab Dose Administration	Participants reporting incomplete dose administration from the study drug administration log.	Week 0 through Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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