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Lupus Erythematosus, SystemicPhase 3NCT02041091

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

A Phase 3 study testing Tabalumab Auto-Injector and Tabalumab Prefilled Syringe in people with Lupus Erythematosus, Systemic, run by Eli Lilly and Company at 44 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Tabalumab Auto-Injector and Tabalumab Prefilled Syringe
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
44 sitesin 3 countries
Study dates
Jan 2014to Nov 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Lupus.
  • Able and willing to have blood drawn for PK sampling.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

44 sites in 3 countries.

44 sites in 3 countries

United States36 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Box Arthritis & Rheumatology of the Carolinas, PLLC

    Charlotte, North Carolina, 28210

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Medvin Clinical Research

    Covina, California, 91723

  • Denver Arthritis Center

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Oklahoma Arthritis Center

    Edmond, Oklahoma, 73013

  • TriWest Research Associates

    El Cajon, California, 92020

  • (AOA) Arthritis & Osteoporosis Associates

    Freehold, New Jersey, 07728

  • West Michigan Rheumatology

    Grand Rapids, Michigan, 49546

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • Innovative Health Research

    Las Vegas, Nevada, 89128

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516

  • ProHealth Partners Medical Group

    Long Beach, California, 90808

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Advanced Pharma Clinical Research

    Miami, Florida, 33136

  • New Horizon Research Center

    Miami, Florida, 33175

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • The Arthritis & Diabetes Clinic Inc.

    Monroe, Louisiana, 71203

  • Virginia Clinical Research

    Norfolk, Virginia, 23507

  • Low Country Research Center

    North Charleston, South Carolina, 29406

  • Westroads Clinical Research-Omaha

    Omaha, Nebraska, 68114

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Arthritis Research of Florida

    Palm Harbor, Florida, 34684

  • Shanahan Rheumatology & Immunotherapy

    Raleigh, North Carolina, 27617

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Arthritis Northwest Rheumatology

    Spokane, Washington, 99204

  • Clayton Medical Research

    St Louis, Missouri, 63117

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • New England Research Associates

    Trumbull, Connecticut, 06611

  • Inlande Rheumatology Clinical Trials

    Upland, California, 91786

  • Clinical Research Center of Reading, LLP

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Puerto Rico5 sites

  • Office: Perez de Jesus, Amarylis

    Caguas, 00725

  • Ramon L. Ortega Colon

    Carolina, 00983

  • GCM Medical Group PSC

    San Juan, 00909

  • Mindful Medical Research

    San Juan, 00918

  • Latin Clinical Trial Center

    Santurce, 00909

Other trials in Puerto Rico

South Korea3 sites

  • 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, 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, 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, 143-729

Other trials in South Korea

About this study

Official title: 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.

Being tested
Tabalumab Auto-Injector, Tabalumab Prefilled Syringe
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tabalumab Auto-InjectorDrug

    Also called LY2127399

    Administered SC

  • Tabalumab Prefilled SyringeDrug

    Also called LY2127399

    Administered SC

Study groups in NCT02041091
Study groupRoleWhat they receive
Tabalumab Auto-InjectorExperimentalTabalumab 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.
Receives: Drug: Tabalumab Auto-Injector
Tabalumab Prefilled SyringeExperimentalTabalumab 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.
Receives: Drug: Tabalumab Prefilled Syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

  2. 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.

    Measured: 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 (7)

  1. 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.

    Measured: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

  2. 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.

    Measured: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

  3. Number of Participants Reporting Incomplete Tabalumab Dose Administration

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

    Measured: Week 0 through Week 12

  4. 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.

    Measured: Week 0 through Week 12

  5. 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.

    Measured: Week 0, Week 4 and Week 8

  6. 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.

    Measured: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

  7. 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.

    Measured: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2014
  4. Study completionNov 2015

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02041091
Sponsor's protocol ID
15193
Other IDs
H9B-MC-BCEI
Status last verified
May 2018
First submitted
17 Jan 2014
Last updated
15 Jun 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tabalumab Auto-Injector and Tabalumab Prefilled Syringe in people with Lupus Erythematosus, Systemic, run by Eli Lilly and Company at 44 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Puerto Rico, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02041091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.

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Clinical Trial NCT02041091 | AzTrials