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

Systemic Lupus Erythematosus Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732940
• Other study ID #: HGS1006-1070
• Secondary ID: 112232
• Status: Terminated
• Phase: Phase 2
• First received: August 8, 2008
• Last updated: August 1, 2013
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: March 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: March 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Central "Igancio Morones Prieto"	San Lusi Potosi
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	STAT Research, Inc.	Dayton	Ohio
United States	Houston Institute for Clinical Research	Houston	Texas
United States	North Shore-LIJ Health System/Rheumatology, Allergy, Immunology	Lake Success	New York
United States	Fiechtner Research, Inc.	Lansing	Michigan
United States	Valerious Medical Group Research Center	Long Beach	California
United States	Rheumatology Associates	Smithtown	New York
United States	Tampa Medical Group, PA	Tampa	Florida
United States	Oklahoma Center for Arthritis Therapy & Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.	SEE ALSO ADVERSE EVENTS RESULTS SECTION	Up to 24 weeks	Yes
Primary	Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24		Baseline, 24 weeks	No
Primary	Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.		Baseline, 24 Weeks	No
Primary	Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24		Baseline, 24 weeks	No
Primary	Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24		Baseline, 24 weeks	No
Primary	Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24		Baseline, 24 Weeks	No
Primary	Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24		Baseline, 24 Weeks	No
Primary	Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24		Baseline, 24 Weeks	No
Primary	Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24		Baseline, 24 Weeks	No
Secondary	Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.		Baseline, 24 weeks	No
Secondary	Absolute Change From Baseline in IgA at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in IgA at Week 24		Baseline, 24 weeks	No
Secondary	Absolute Change From Baseline in IgG at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in IgG at Week 24		Baseline, 24 Weeks	No
Secondary	Absolute Change From Baseline in IgM at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in IgM at Week 24		Baseline, 24 weeks	No
Secondary	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.	Baseline, 24 Weeks	No
Secondary	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.	Baseline, 24 weeks	No
Secondary	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.	Baseline, 24 Weeks	No
Secondary	Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24		Baseline, 24 weeks	No
Secondary	Absolute Change From Baseline in Complement C3 at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in Compliment C3 at Week 24		Baseline, 24 Weeks	No
Secondary	Absolute Change From Baseline in Complement C4 at Week 24		Baseline, 24 weeks	No
Secondary	Median Percent Change From Baseline in Complement C4 at Week 24		Baseline, 24 Weeks	No
Secondary	Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in Anti-dsDNA at Week 24		Baseline, 24 weeks	No
Secondary	Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in HDL at Week 24		Baseline, 24 week	No
Secondary	Absolute Change From Baseline in Total Cholesterol at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in Total Cholesterol at Week 24		Baseline, 24 Weeks	No
Secondary	Median Percent Change From Baseline in Triglycerides at Week 24		Baseline, 24 weeks	No
Secondary	Absolute Change From Baseline in Triglycerides at Week 24		Baseline, 24 Weeks	No