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CompletedNCT01162681PEARL-SCUpdated Mar 4, 2014

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

A Phase 2 interventional study of A-623 and A-623 in Systemic Lupus Erythematosus, sponsored by Anthera Pharmaceuticals. Completed at 74 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-04.

Sponsored by Anthera Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
547
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • SLE
  • Lupus
  • Lupus Erythematosus, Systemic
  • Autoimmune Diseases
  • A-623
  • Blisibimod
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 547 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Anthera Pharmaceuticals is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
547 participants (actual)

Study arms

  • Experimental
    A-623 high dose weekly

    Drug: A-623

  • Experimental
    A-623 low dose weekly

    Drug: A-623

  • Experimental
    A-623 high dose every 4 weeks

    Drug: A-623

  • Placebo comparator
    Placebo

    Other: Placebo Comparator

Interventions

  • DrugA-623

    High dose given subcutaneously once a week for up to 52 weeks

  • DrugA-623

    Low dose given subcutaneously once a week for up to 52 weeks

  • DrugA-623

    High dose given subcutaneously once every 4 weeks for up to 52 weeks

  • OtherPlacebo Comparator

    Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

06

What researchers measure

Primary outcomes

  1. SLE response

    The % of subjects with SLE response compared with baseline at the time of assessment

    Time frame: Various timepoints through Week 52

Secondary outcomes

  1. B cell reduction

    Time frame: Various timepoints through Week 52

  2. Time to first flare

    Time frame: Various timepoints through Week 52

  3. FACIT-fatigue score

    Time frame: Various timepoints through Week 52

  4. Reduction in prednisone dose

    Time frame: Various timepoints through Week 52

  5. Change in IgG, IgM,C3 and C4

    Time frame: Various timepoints through Week 52

  6. Flare rates

    Time frame: Various timepoints through Week 52

  7. SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9

    Time frame: Various timepoints through Week 52

07

Study locations

74 sites
  • Investigator Site 103
    Birmingham, Alabama 35294, United States
  • Investigator Site 113
    Long Beach, California 90806, United States
  • Investigator Site 108
    Los Angeles, California 90095, United States
  • Investigator Site 110
    Upland, California 91786, United States
  • Investigator Site 105
    Orlando, Florida 32806, United States
  • Investigator Site 102
    Tampa, Florida 33614, United States
  • Investigator Site 117
    Baltimore, Maryland 21205, United States
  • Investigator Site 104
    Lansing, Michigan 48910, United States
  • Investigator Site 106
    Lake Success, New York 11042, United States
  • Investigator Site 114
    Smithtown, New York 11787, United States
  • Investigator Site 101
    Greenville, North Carolina 27834, United States
  • Investigator Site 112
    Oklahoma City, Oklahoma 73104, United States
  • Investigator Site 111
    Tulsa, Oklahoma 74104, United States
  • Investigator Site 115
    Houston, Texas 77034, United States
  • Investigator Site 404
    Caba, Buenos Aires C1015ABO, Argentina
  • Investigator Site 402
    Caba, Buenos Aires C1280AEB, Argentina
  • Investigator Site 403
    Rosario, Santa Fe S2000PBJ, Argentina
  • Investigator Site 406
    San Miguel de Tucuman, Tucuman T4000AXL, Argentina
  • Investigator Site 407
    Buenos Aires, C1121ABE, Argentina
  • Investigator Site 401
    Buenos Aires, C1431FWO, Argentina
  • Investigator Site 408
    San Juan, 5400, Argentina
  • Investigator Site 504
    Salvador, Bahia 40050-010, Brazil
  • Investigator Site 509
    Goias, Goiania 74605-050, Brazil
  • Investigator Site 507
    Goiania, GO 74110120, Brazil
  • Investigator Site 506
    Juiz de Fora, MG 36010-570, Brazil
  • Investigator Site 512
    Porto Alegre, Rio de Grande do Sul 90035-903, Brazil
  • Investigator Site 503
    Rio de Janeiro, RJ 21941, Brazil
  • Investigator Site 502
    Porto Alegre, RS 9061-0000, Brazil
  • Investigator Site 510
    Campinas, Sao Paulo 13015, Brazil
  • Investigator Site 501
    Sao Paulo, SP 04039-901, Brazil
  • Investigator Site 511
    Rio de Janeiro, 20551, Brazil
  • Investigator Site 505
    Sao Paulo, 04038-004, Brazil
  • Investigator Site 602
    Santiago de Chile, 8330033, Chile
  • Investigator Site 605
    Santiago, Chile
  • Investigator Site 606
    Santiago, Chile
  • Investigator Site 601
    Vina del Mar, 2570017, Chile
  • Investigator Site 706
    Medellin, Antioquia, Colombia
  • Investigator Site 710
    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 702
    Bogota, Colombia
  • Investigator Site 705
    Bogota, Colombia
  • Investigator Site 709
    Bogota, Colombia
  • Investigator Site 711
    Bucaramanga, Colombia
  • Investigator Site 708
    Medellin, Colombia
  • Investigator Site 153
    New Territories, Shatin, Hong Kong
  • Investigator Site 151
    Hong Kong, Hong Kong
  • Investigator Site 205
    Secunderabad, Andhra Pradesh 500003, India
  • Investigator Site 203
    Bangalore, Kamataka 560034, India
  • Investigator Site 204
    Trivandrum, Kerala 695011, India
  • Investigator Site 201
    Mumbai, Maharashtra 400012, India
  • Investigator Site 803
    Mexico City, D.f. 06726, Mexico
  • Inestigator Site 809
    Mexico, D.f. 14000, Mexico
  • Investigator Site 802
    Toluca, Estado de Mexico 50120, Mexico
  • Investigator Site 806
    Guadalajara, Jalisco 44280, Mexico
  • Investigator Site 804
    Morelia, Michoacan 58070, Mexico
  • Investigator Site 808
    Guanajuato, Mexico
  • Investigator Site 805
    Mexico, Mexico
  • Investigator Site 807
    Mexico, Mexico
  • Investigator Site 801
    San Luis Potosi, 78240, Mexico
  • Investigator Site 901
    Cayma, Arequipa, Peru
  • Investigator Site 902
    Bellavista Callao, Callao, Peru
  • Investigator Site 903
    Lima, L-01, Peru
  • Investigator Site 905
    Lima, L27, Peru
  • Investigator Site 904
    Lima, Peru
  • Investigator Site 303
    Davao City, Davao 8000, Philippines
  • Investigator Site 304
    Manila City, Metro Manila 1008, Philippines
  • Investigator Site 302
    Cebu, 6000, Philippines
  • Investigator Site 305
    Davao, 8000, Philippines
  • Investigator Site 354
    Taichung, 402, Taiwan
  • Investigator Site 352
    Taichung, 414, Taiwan
  • Investigator Site 351
    Taipei, 100, Taiwan
08

References and documents

Publications

  • Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. PubMed 33687069 ↗
  • Furie RA, Leon G, Thomas M, Petri MA, Chu AD, Hislop C, Martin RS, Scheinberg MA; PEARL-SC Study. A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study. Ann Rheum Dis. 2015 Sep;74(9):1667-75. doi: 10.1136/annrheumdis-2013-205144. Epub 2014 Apr 19. PubMed 24748629 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01162681
Lead sponsor
Anthera Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 15, 2010
Start date
Jul 2010
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Mar 4, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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