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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01162681
First received: July 13, 2010
Last updated: January 30, 2014
Last verified: January 2014
  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:


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

  Show 74 Study Locations
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
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014