A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
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| ClinicalTrials.gov Identifier: NCT02041091 |
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Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : January 20, 2014
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Erythematosus, Systemic | Drug: Tabalumab Auto-Injector Drug: Tabalumab Prefilled Syringe | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 226 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | January 2014 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | November 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
MedlinePlus related topics:
Lupus
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Tabalumab Auto-Injector
Administered SC
Other Name: LY2127399 |
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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.
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Drug: Tabalumab Prefilled Syringe
Administered SC
Other Name: LY2127399 |
Primary Outcome Measures :
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose [ 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 ]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 [ 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 ]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 [ 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 ]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 [ 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 ]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 [ Time Frame: Week 0 through Week 12 ]Participants reporting incomplete dose administration from the study drug administration log.
- Number of Participants Developing Anti-Tabalumab Antibodies [ Time Frame: Week 0 through Week 12 ]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 [ Time Frame: Week 0, Week 4 and Week 8 ]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 [ 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 ]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 [ 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 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041091
Locations
Show 44 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 |
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02041091 |
| Other Study ID Numbers: |
15193 H9B-MC-BCEI ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | January 20, 2014 Key Record Dates |
| Results First Posted: | June 15, 2018 |
| Last Update Posted: | June 15, 2018 |
| Last Verified: | May 2018 |
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |