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

January 30, 2014 updated by: Anthera Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

547

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: A-623 high dose weekly
Drug: A-623
High dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
Low dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks
Experimental: A-623 low dose weekly
Drug: A-623
High dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
Low dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks
Experimental: A-623 high dose every 4 weeks
Drug: A-623
High dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
Low dose given subcutaneously once a week for up to 52 weeks
Drug: A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE response
Time Frame: Various timepoints through Week 52
The % of subjects with SLE response compared with baseline at the time of assessment
Various timepoints through Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-SLE3321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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