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

  Hide Study Locations
Locations
United States, Alabama
Investigator Site 103
Birmingham, Alabama, United States, 35294
United States, California
Investigator Site 113
Long Beach, California, United States, 90806
Investigator Site 108
Los Angeles, California, United States, 90095
Investigator Site 110
Upland, California, United States, 91786
United States, Florida
Investigator Site 105
Orlando, Florida, United States, 32806
Investigator Site 102
Tampa, Florida, United States, 33614
United States, Maryland
Investigator Site 117
Baltimore, Maryland, United States, 21205
United States, Michigan
Investigator Site 104
Lansing, Michigan, United States, 48910
United States, New York
Investigator Site 106
Lake Success, New York, United States, 11042
Investigator Site 114
Smithtown, New York, United States, 11787
United States, North Carolina
Investigator Site 101
Greenville, North Carolina, United States, 27834
United States, Oklahoma
Investigator Site 112
Oklahoma City, Oklahoma, United States, 73104
Investigator Site 111
Tulsa, Oklahoma, United States, 74104
United States, Texas
Investigator Site 115
Houston, Texas, United States, 77034
Argentina
Investigator Site 402
Caba, Buenos Aires, Argentina, C1280AEB
Investigator Site 404
Caba, Buenos Aires, Argentina, C1015ABO
Investigator Site 403
Rosario, Santa Fe, Argentina, S2000PBJ
Investigator Site 406
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Investigator Site 401
Buenos Aires, Argentina, C1431FWO
Investigator Site 407
Buenos Aires, Argentina, C1121ABE
Investigator Site 408
San Juan, Argentina, 5400
Brazil
Investigator Site 504
Salvador, Bahia, Brazil, 40050-010
Investigator Site 509
Goias, Goiania, Brazil, 74605-050
Investigator Site 507
Goiania, GO, Brazil, 74110120
Investigator Site 506
Juiz de Fora, MG, Brazil, 36010-570
Investigator Site 512
Porto Alegre, Rio de Grande do Sul, Brazil, 90035-903
Investigator Site 503
Rio de Janeiro, RJ, Brazil, 21941
Investigator Site 502
Porto Alegre, RS, Brazil, 9061-0000
Investigator Site 510
Campinas, Sao Paulo, Brazil, 13015
Investigator Site 501
Sao Paulo, SP, Brazil, 04039-901
Investigator Site 511
Rio de Janeiro, Brazil, 20551
Investigator Site 505
Sao Paulo, Brazil, 04038-004
Chile
Investigator Site 606
Santiago, Chile
Investigator Site 605
Santiago, Chile
Investigator Site 602
Santiago de Chile, Chile, 8330033
Investigator Site 601
Vina del Mar, Chile, 2570017
Colombia
Investigator Site 710
Medellin, Antioquia, Colombia
Investigator Site 706
Medellin, Antioquia, Colombia
Investigator Site 701
Barranquilla, Atlantico, Colombia
Investigator Site 704
Barranquilla, Atlántico, Colombia
Investigator Site 703
Bogota, Cundinamarca, Colombia
Investigator Site 707
Bucaramanga, Santander, Colombia
Investigator Site 705
Bogota, Colombia
Investigator Site 709
Bogota, Colombia
Investigator Site 702
Bogota, Colombia
Investigator Site 711
Bucaramanga, Colombia
Investigator Site 708
Medellin, Colombia
Hong Kong
Investigator Site 153
New Territories, Shatin, Hong Kong
Investigator Site 151
Hong Kong, Hong Kong
India
Investigator Site 205
Secunderabad, Andhra Pradesh, India, 500003
Investigator Site 203
Bangalore, Kamataka, India, 560034
Investigator Site 204
Trivandrum, Kerala, India, 695011
Investigator Site 201
Mumbai, Maharashtra, India, 400012
Mexico
Inestigator Site 809
Mexico, D.f., Mexico, 14000
Investigator Site 803
Mexico City, D.f., Mexico, 06726
Investigator Site 802
Toluca, Estado de Mexico, Mexico, 50120
Investigator Site 806
Guadalajara, Jalisco, Mexico, 44280
Investigator Site 804
Morelia, Michoacan, Mexico, 58070
Investigator Site 808
Guanajuato, Mexico
Investigator Site 805
Mexico, Mexico
Investigator Site 807
Mexico, Mexico
Investigator Site 801
San Luis Potosi, Mexico, 78240
Peru
Investigator Site 901
Cayma, Arequipa, Peru
Investigator Site 902
Bellavista Callao, Callao, Peru
Investigator Site 905
Lima, Peru, L27
Investigator Site 904
Lima, Peru
Investigator Site 903
Lima, Peru, L-01
Philippines
Investigator Site 303
Davao City, Davao, Philippines, 8000
Investigator Site 304
Manila City, Metro Manila, Philippines, 1008
Investigator Site 302
Cebu, Philippines, 6000
Investigator Site 305
Davao, Philippines, 8000
Taiwan
Investigator Site 352
Taichung, Taiwan, 414
Investigator Site 354
Taichung, Taiwan, 402
Investigator Site 351
Taipei, Taiwan, 100
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 October 20, 2014