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

COMPLETEDPHASE2

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

A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

NCT01162681•Anthera Pharmaceuticals

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Key Dates

Start Date

July 1, 2010

Primary Completion Date

April 1, 2012

Completion Date

April 1, 2012

Last Updated

March 4, 2014

Enrollment

547

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

A-623

DRUG

A-623

DRUG

A-623

DRUG

Placebo Comparator

OTHER

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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