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

Purpose

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

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: A-623 Other: Placebo Comparator	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:

SLE response [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
The % of subjects with SLE response compared with baseline at the time of assessment

Secondary Outcome Measures:

B cell reduction [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
Time to first flare [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
FACIT-fatigue score [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
Reduction in prednisone dose [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
Change in IgG, IgM,C3 and C4 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
Flare rates [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 [ Time Frame: Various timepoints through Week 52 ] [ Designated as safety issue: No ]


Enrollment:	547
Study Start Date:	July 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A-623 high dose weekly	Drug: A-623 High dose given subcutaneously once a week for up to 52 weeks
Experimental: A-623 low dose weekly	Drug: A-623 Low dose given subcutaneously once a week for up to 52 weeks
Experimental: A-623 high dose every 4 weeks	Drug: A-623 High dose given subcutaneously once every 4 weeks for up to 52 weeks
Placebo Comparator: Placebo	Other: Placebo Comparator Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162681

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Sponsors and Collaborators

Anthera Pharmaceuticals

More Information

No publications provided


Responsible Party:	Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01162681 History of Changes
Other Study ID Numbers:	AN-SLE3321
Study First Received:	July 13, 2010
Last Updated:	January 30, 2014
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Chile: Instituto de Salud Pública de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos India: Drugs Controller General of India Mexico: Federal Commission for Protection Against Health Risks Peru: Instituto Nacional de Salud Philippines: Bureau of Food and Drugs

Keywords provided by Anthera Pharmaceuticals:


SLE Lupus Lupus Erythematosus, Systemic	Autoimmune Diseases A-623 Blisibimod

Additional relevant MeSH terms:


Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases

ClinicalTrials.gov processed this record on March 02, 2015