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

Phase 3TerminatedNCT02041091

Eli Lilly and Company226 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

226

Conditions

Lupus Erythematosus, Systemic

Interventions

Tabalumab Auto-InjectorDRUG

Administered SC

Tabalumab Prefilled SyringeDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (44)

Outcomes

Primary Outcomes

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.

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

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.

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 Outcomes

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.

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

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.

Data from ClinicalTrials.gov

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Medvin Clinical Research

Covina, California, United States

TriWest Research Associates

El Cajon, California, United States

ProHealth Partners Medical Group

Long Beach, California, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

Desert Medical Advances

Palm Desert, California, United States

Inlande Rheumatology Clinical Trials

Upland, California, United States

Denver Arthritis Center

Denver, Colorado, United States

New England Research Associates

Trumbull, Connecticut, United States

Advanced Pharma Clinical Research

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

...and 34 more locations

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

Number of Participants Reporting Incomplete Tabalumab Dose Administration

Participants reporting incomplete dose administration from the study drug administration log.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

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