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

Primary Purpose

Systemic Lupus Erythematosus

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Belimumab 100 mg SC

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Systemic Lupus Erythematosus, Antibodies, Autoimmune Diseases, Belimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham
Valerious Medical Group Research Center
Tampa Medical Group, PA
Fiechtner Research, Inc.
SUNY Downstate Medical Center
North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
Rheumatology Associates
STAT Research, Inc.
Oklahoma Center for Arthritis Therapy & Research
Houston Institute for Clinical Research
Hospital Central "Igancio Morones Prieto"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Belimumab Q2WKS

Belimumab 3X/WK

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

Secondary Outcome Measures

Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.

Absolute Change From Baseline in IgA at Week 24

Median Percent Change From Baseline in IgA at Week 24

Absolute Change From Baseline in IgG at Week 24

Median Percent Change From Baseline in IgG at Week 24

Absolute Change From Baseline in IgM at Week 24

Median Percent Change From Baseline in IgM at Week 24

Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24

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.

Mean Percent Change From Baseline in PGA Score at Week 24.

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.

Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.

Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24

Absolute Change From Baseline in Complement C3 at Week 24

Median Percent Change From Baseline in Compliment C3 at Week 24

Absolute Change From Baseline in Complement C4 at Week 24

Median Percent Change From Baseline in Complement C4 at Week 24

Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24

Median Percent Change From Baseline in Anti-dsDNA at Week 24

Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24

Median Percent Change From Baseline in HDL at Week 24

Absolute Change From Baseline in Total Cholesterol at Week 24

Median Percent Change From Baseline in Total Cholesterol at Week 24

Median Percent Change From Baseline in Triglycerides at Week 24

Absolute Change From Baseline in Triglycerides at Week 24

Full Information

NCT ID

NCT00732940

First Posted

August 8, 2008

Last Updated

August 1, 2013

Sponsor

Human Genome Sciences Inc.

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00732940

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

Sponsor terminated study for business reasons.

Study Start Date

October 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Human Genome Sciences Inc.

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

SLE, Lupus, Systemic Lupus Erythematosus, Antibodies, Autoimmune Diseases, Belimumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Belimumab Q2WKS

Arm Type

Experimental

Arm Description

Arm Title

Belimumab 3X/WK

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Belimumab 100 mg SC

Other Intervention Name(s)

LymphoStat-B™

Intervention Description

Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.

Intervention Type

Drug

Intervention Name(s)

Belimumab 100 mg SC

Intervention Description

Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

Primary Outcome Measure Information:

Title

Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

Description

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249-7201

Country

United States

Facility Name

Valerious Medical Group Research Center

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Tampa Medical Group, PA

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Fiechtner Research, Inc.

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

SUNY Downstate Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

North Shore-LIJ Health System/Rheumatology, Allergy, Immunology

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Rheumatology Associates

City

Smithtown

State/Province

New York

ZIP/Postal Code

11787

Country

United States

Facility Name

STAT Research, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45408

Country

United States

Facility Name

Oklahoma Center for Arthritis Therapy & Research

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Houston Institute for Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Hospital Central "Igancio Morones Prieto"

City

San Lusi Potosi

ZIP/Postal Code

78240

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

31302695

Citation

van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

Results Reference

derived

Learn more about this trial

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

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