Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

August 1, 2013 updated by: Human Genome Sciences Inc.

A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Lusi Potosi, Mexico, 78240
        • Hospital Central "Igancio Morones Prieto"
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-7201
        • University of Alabama at Birmingham
    • California
      • Long Beach, California, United States, 90806
        • Valerious Medical Group Research Center
    • Florida
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, PA
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Fiechtner Research, Inc.
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Lake Success, New York, United States, 11042
        • North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
      • Smithtown, New York, United States, 11787
        • Rheumatology Associates
    • Ohio
      • Dayton, Ohio, United States, 45408
        • STAT Research, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Center For Arthritis Therapy & Research
    • Texas
      • Houston, Texas, United States, 77074
        • Houston Institute for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Active SLE disease
  • On stable SLE treatment regimen

Exclusion Criteria:

  • Pregnant or nursing
  • Have received treatment with an B cell targeted therapy
  • Have received treatment with a biologic investigational agent in the past year
  • Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
  • Have severe lupus kidney disease
  • Have active central nervous system (CNS) lupus
  • Have required management of acute or chronic infections with the past 60 days
  • Have current drug or alcohol abuse or dependence or within the past year
  • Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Belimumab Q2WKS
Every other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Drug: Belimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Other Names:
  • LymphoStat-B™
Drug: Belimumab 100 mg SC
Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
Experimental: Belimumab 3X/WK
Three times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Drug: Belimumab 100 mg SC
Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
Other Names:
  • LymphoStat-B™
Drug: Belimumab 100 mg SC
Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
Time Frame: Up to 24 weeks
SEE ALSO ADVERSE EVENTS RESULTS SECTION
Up to 24 weeks
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in IgA at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in IgA at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in IgG at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in IgG at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Absolute Change From Baseline in IgM at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in IgM at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
Time Frame: Baseline, 24 Weeks
PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Baseline, 24 Weeks
Mean Percent Change From Baseline in PGA Score at Week 24.
Time Frame: Baseline, 24 weeks
The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Baseline, 24 weeks
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24
Time Frame: Baseline, 24 Weeks
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Baseline, 24 Weeks
Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in Complement C3 at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in Compliment C3 at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Absolute Change From Baseline in Complement C4 at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Median Percent Change From Baseline in Complement C4 at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in Anti-dsDNA at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in HDL at Week 24
Time Frame: Baseline, 24 week
Baseline, 24 week
Absolute Change From Baseline in Total Cholesterol at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in Total Cholesterol at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks
Median Percent Change From Baseline in Triglycerides at Week 24
Time Frame: Baseline, 24 weeks
Baseline, 24 weeks
Absolute Change From Baseline in Triglycerides at Week 24
Time Frame: Baseline, 24 Weeks
Baseline, 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Genome Sciences Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HGS1006-1070
  • 112232 (Other Identifier: GlaxoSmithKline)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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