PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Other: Placebo Comparator; Drug: A-623

• Registration Number: NCT01162681
• Lead Sponsor: Anthera Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-15
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-01
• Disposition First Submitted: 2014-01-30
• Disposition First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Disposition First Posted: 2014-03-04
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 547

Inclusion Criteria

• Diagnosis of SLE by American College of Rheumatology guidelines.
• On stable SLE treatment
• Active SLE disease
• Serologically active
• 18 years of age or older
• Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria

• Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
• Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
• Liver disease.
• Anemia, neutropenia, or thrombocytopenia.
• Malignancy within past 5 years
• Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
• History of active tuberculosis or a history of tuberculosis infection.
• Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
• Prior administration of any B cell depleting therapy in the past 18 months.
• Pregnant or nursing
• History of congenital immunodeficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	-
A-623 high dose weekly	A-623	-
A-623 low dose weekly	A-623	-
A-623 high dose every 4 weeks	A-623	-

Primary Outcome Measures

Name	Time	Method
SLE response	Various timepoints through Week 52	The % of subjects with SLE response compared with baseline at the time of assessment

Secondary Outcome Measures

Name	Time	Method
Time to first flare	Various timepoints through Week 52
Reduction in prednisone dose	Various timepoints through Week 52
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9	Various timepoints through Week 52
B cell reduction	Various timepoints through Week 52
FACIT-fatigue score	Various timepoints through Week 52
Change in IgG, IgM,C3 and C4	Various timepoints through Week 52
Flare rates	Various timepoints through Week 52

Trial Locations

Locations (74)

Investigator Site 103; 🇺🇸 Birmingham, Alabama, United States

Investigator Site 113; 🇺🇸 Long Beach, California, United States

Investigator Site 108; 🇺🇸 Los Angeles, California, United States

Investigator Site 110; 🇺🇸 Upland, California, United States

Investigator Site 105; 🇺🇸 Orlando, Florida, United States

Investigator Site 102; 🇺🇸 Tampa, Florida, United States

Investigator Site 117; 🇺🇸 Baltimore, Maryland, United States

Investigator Site 104; 🇺🇸 Lansing, Michigan, United States

Investigator Site 106; 🇺🇸 Lake Success, New York, United States

Investigator Site 114; 🇺🇸 Smithtown, New York, United States

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