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

NCT02041091 | Terminated Phase 3 Results

• 2 other identifiers: 15193H9B-MC-BCEI
• Study Type: interventional
• Target: 226
• Locations: 3 countries
• Sites: 44

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.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight

  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

  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

  Week 0 through Week 12

• Number of Participants Developing Anti-Tabalumab Antibodies

  Week 0 through Week 12

• Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score

  Week 0, Week 4 and Week 8

Study Arms (2)

Tabalumab Auto-Injector

EXPERIMENTAL

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.

Drug: Tabalumab Auto-Injector

Tabalumab Prefilled Syringe

EXPERIMENTAL

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.

Drug: Tabalumab Prefilled Syringe

Interventions

Tabalumab Auto-Injector DRUG

Administered SC

Also known as: LY2127399

Tabalumab Auto-Injector

Tabalumab Prefilled Syringe DRUG

Administered SC

Also known as: LY2127399

Tabalumab Prefilled Syringe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (44)

Medvin Clinical Research

Covina, California, 91723, United States

Location

TriWest Research Associates

El Cajon, California, 92020, United States

Location

ProHealth Partners Medical Group

Long Beach, California, 90808, United States

Location

Wallace Rheumatic Study Center

Los Angeles, California, 90048, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Inlande Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Denver Arthritis Center

Denver, Colorado, 80230, United States

Location

New England Research Associates

Trumbull, Connecticut, 06611, United States

Location

Advanced Pharma Clinical Research

Miami, Florida, 33136, United States

Location

New Horizon Research Center

Miami, Florida, 33175, United States

Location

Arthritis Research of Florida

Palm Harbor, Florida, 34684, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

The Arthritis & Diabetes Clinic Inc.

Monroe, Louisiana, 71203, United States

Location

West Michigan Rheumatology

Grand Rapids, Michigan, 49546, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Westroads Clinical Research-Omaha

Omaha, Nebraska, 68114, United States

Location

Innovative Health Research

Las Vegas, Nevada, 89128, United States

Location

(AOA) Arthritis & Osteoporosis Associates

Freehold, New Jersey, 07728, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Box Arthritis & Rheumatology of the Carolinas, PLLC

Charlotte, North Carolina, 28210, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Shanahan Rheumatology & Immunotherapy

Raleigh, North Carolina, 27617, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Paramount Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Oklahoma Arthritis Center

Edmond, Oklahoma, 73013, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Research Center of Reading, LLP

Wyomissing, Pennsylvania, 19610, United States

Location

Low Country Research Center

North Charleston, South Carolina, 29406, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

Mountain State Clinical Research

Clarksburg, West Virginia, 26301, United States

Location

Office: Perez de Jesus, Amarylis

Caguas, 00725, Puerto Rico

Location

Ramon L. Ortega Colon

Carolina, 00983, Puerto Rico

Location

GCM Medical Group PSC

San Juan, 00909, Puerto Rico

Location

Mindful Medical Research

San Juan, 00918, Puerto Rico

Location

Latin Clinical Trial Center

Santurce, 00909, Puerto Rico

Location

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, South Korea

Location

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, South Korea

Location

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, South Korea

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

tabalumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-05

Locations

US (36); KR (3); PR (5)