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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A-623
A-623
A-623
Placebo Comparator
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 103
  • Investigator Site 113
  • Investigator Site 108
  • Investigator Site 110
  • Investigator Site 105
  • Investigator Site 102
  • Investigator Site 117
  • Investigator Site 104
  • Investigator Site 106
  • Investigator Site 114
  • Investigator Site 101
  • Investigator Site 112
  • Investigator Site 111
  • Investigator Site 115
  • Investigator Site 404
  • Investigator Site 402
  • Investigator Site 403
  • Investigator Site 406
  • Investigator Site 407
  • Investigator Site 401
  • Investigator Site 408
  • Investigator Site 504
  • Investigator Site 509
  • Investigator Site 507
  • Investigator Site 506
  • Investigator Site 512
  • Investigator Site 503
  • Investigator Site 502
  • Investigator Site 510
  • Investigator Site 501
  • Investigator Site 511
  • Investigator Site 505
  • Investigator Site 602
  • Investigator Site 605
  • Investigator Site 606
  • Investigator Site 601
  • Investigator Site 706
  • Investigator Site 710
  • Investigator Site 701
  • Investigator Site 704
  • Investigator Site 703
  • Investigator Site 707
  • Investigator Site 702
  • Investigator Site 705
  • Investigator Site 709
  • Investigator Site 711
  • Investigator Site 708
  • Investigator Site 153
  • Investigator Site 151
  • Investigator Site 205
  • Investigator Site 203
  • Investigator Site 204
  • Investigator Site 201
  • Investigator Site 803
  • Inestigator Site 809
  • Investigator Site 802
  • Investigator Site 806
  • Investigator Site 804
  • Investigator Site 808
  • Investigator Site 805
  • Investigator Site 807
  • Investigator Site 801
  • Investigator Site 901
  • Investigator Site 902
  • Investigator Site 903
  • Investigator Site 905
  • Investigator Site 904
  • Investigator Site 303
  • Investigator Site 304
  • Investigator Site 302
  • Investigator Site 305
  • Investigator Site 354
  • Investigator Site 352
  • Investigator Site 351

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A-623 high dose weekly

A-623 low dose weekly

A-623 high dose every 4 weeks

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

B cell reduction
Time to first flare
FACIT-fatigue score
Reduction in prednisone dose
Change in IgG, IgM,C3 and C4
Flare rates
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9

Full Information

First Posted
July 13, 2010
Last Updated
January 30, 2014
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01162681
Brief Title
PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Acronym
PEARL-SC
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-623 high dose weekly
Arm Type
Experimental
Arm Title
A-623 low dose weekly
Arm Type
Experimental
Arm Title
A-623 high dose every 4 weeks
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
High dose given subcutaneously once a week for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
Low dose given subcutaneously once a week for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
A-623
Intervention Description
High dose given subcutaneously once every 4 weeks for up to 52 weeks
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
Primary Outcome Measure Information:
Title
SLE response
Description
The % of subjects with SLE response compared with baseline at the time of assessment
Time Frame
Various timepoints through Week 52
Secondary Outcome Measure Information:
Title
B cell reduction
Time Frame
Various timepoints through Week 52
Title
Time to first flare
Time Frame
Various timepoints through Week 52
Title
FACIT-fatigue score
Time Frame
Various timepoints through Week 52
Title
Reduction in prednisone dose
Time Frame
Various timepoints through Week 52
Title
Change in IgG, IgM,C3 and C4
Time Frame
Various timepoints through Week 52
Title
Flare rates
Time Frame
Various timepoints through Week 52
Title
SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9
Time Frame
Various timepoints through Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigator Site 103
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigator Site 113
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigator Site 108
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Investigator Site 110
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Investigator Site 105
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigator Site 102
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Investigator Site 117
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Investigator Site 104
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Investigator Site 106
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Investigator Site 114
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
Investigator Site 101
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigator Site 112
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigator Site 111
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigator Site 115
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigator Site 404
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Investigator Site 402
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Investigator Site 403
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Investigator Site 406
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Investigator Site 407
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Investigator Site 401
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Investigator Site 408
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Investigator Site 504
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40050-010
Country
Brazil
Facility Name
Investigator Site 509
City
Goias
State/Province
Goiania
ZIP/Postal Code
74605-050
Country
Brazil
Facility Name
Investigator Site 507
City
Goiania
State/Province
GO
ZIP/Postal Code
74110120
Country
Brazil
Facility Name
Investigator Site 506
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Investigator Site 512
City
Porto Alegre
State/Province
Rio de Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Investigator Site 503
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941
Country
Brazil
Facility Name
Investigator Site 502
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
9061-0000
Country
Brazil
Facility Name
Investigator Site 510
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13015
Country
Brazil
Facility Name
Investigator Site 501
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Investigator Site 511
City
Rio de Janeiro
ZIP/Postal Code
20551
Country
Brazil
Facility Name
Investigator Site 505
City
Sao Paulo
ZIP/Postal Code
04038-004
Country
Brazil
Facility Name
Investigator Site 602
City
Santiago de Chile
ZIP/Postal Code
8330033
Country
Chile
Facility Name
Investigator Site 605
City
Santiago
Country
Chile
Facility Name
Investigator Site 606
City
Santiago
Country
Chile
Facility Name
Investigator Site 601
City
Vina del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
Investigator Site 706
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Investigator Site 710
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Investigator Site 701
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Investigator Site 704
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Facility Name
Investigator Site 703
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Investigator Site 707
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Investigator Site 702
City
Bogota
Country
Colombia
Facility Name
Investigator Site 705
City
Bogota
Country
Colombia
Facility Name
Investigator Site 709
City
Bogota
Country
Colombia
Facility Name
Investigator Site 711
City
Bucaramanga
Country
Colombia
Facility Name
Investigator Site 708
City
Medellin
Country
Colombia
Facility Name
Investigator Site 153
City
New Territories
State/Province
Shatin
Country
Hong Kong
Facility Name
Investigator Site 151
City
Hong Kong
Country
Hong Kong
Facility Name
Investigator Site 205
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Investigator Site 203
City
Bangalore
State/Province
Kamataka
ZIP/Postal Code
560034
Country
India
Facility Name
Investigator Site 204
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Investigator Site 201
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Investigator Site 803
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Inestigator Site 809
City
Mexico
State/Province
D.f.
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Investigator Site 802
City
Toluca
State/Province
Estado de Mexico
ZIP/Postal Code
50120
Country
Mexico
Facility Name
Investigator Site 806
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Investigator Site 804
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Investigator Site 808
City
Guanajuato
Country
Mexico
Facility Name
Investigator Site 805
City
Mexico
Country
Mexico
Facility Name
Investigator Site 807
City
Mexico
Country
Mexico
Facility Name
Investigator Site 801
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Investigator Site 901
City
Cayma
State/Province
Arequipa
Country
Peru
Facility Name
Investigator Site 902
City
Bellavista Callao
State/Province
Callao
Country
Peru
Facility Name
Investigator Site 903
City
Lima
ZIP/Postal Code
L-01
Country
Peru
Facility Name
Investigator Site 905
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Investigator Site 904
City
Lima
Country
Peru
Facility Name
Investigator Site 303
City
Davao City
State/Province
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Investigator Site 304
City
Manila City
State/Province
Metro Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
Investigator Site 302
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Investigator Site 305
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Investigator Site 354
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Investigator Site 352
City
Taichung
ZIP/Postal Code
414
Country
Taiwan
Facility Name
Investigator Site 351
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
PubMed Identifier
24748629
Citation
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.
Results Reference
derived

Learn more about this trial

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

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