Clinical trial NCT01162681: PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: SLE response
timeFrame: Various timepoints through Week 52
Secondary outcomes:
measure: B cell reduction
timeFrame: Various timepoints through Week 52
measure: Time to first flare
timeFrame: Various timepoints through Week 52
measure: FACIT-fatigue score
timeFrame: Various timepoints through Week 52
measure: Reduction in prednisone dose
timeFrame: Various timepoints through Week 52
measure: Change in IgG, IgM,C3 and C4
timeFrame: Various timepoints through Week 52
measure: Flare rates
timeFrame: Various timepoints through Week 52
measure: SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9
timeFrame: Various timepoints through Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator Site 103
state: Alabama
city: Long Beach
country: United States
facility: Investigator Site 113
state: California
city: Los Angeles
country: United States
facility: Investigator Site 108
state: California
city: Upland
country: United States
facility: Investigator Site 110
state: California
city: Orlando
country: United States
facility: Investigator Site 105
state: Florida
city: Tampa
country: United States
facility: Investigator Site 102
state: Florida
city: Baltimore
country: United States
facility: Investigator Site 117
state: Maryland
city: Lansing
country: United States
facility: Investigator Site 104
state: Michigan
city: Lake Success
country: United States
facility: Investigator Site 106
state: New York
city: Smithtown
country: United States
facility: Investigator Site 114
state: New York
city: Greenville
country: United States
facility: Investigator Site 101
state: North Carolina
city: Oklahoma City
country: United States
facility: Investigator Site 112
state: Oklahoma
city: Tulsa
country: United States
facility: Investigator Site 111
state: Oklahoma
city: Houston
country: United States
facility: Investigator Site 115
state: Texas
city: Caba
country: Argentina
facility: Investigator Site 404
state: Buenos Aires
city: Caba
country: Argentina
facility: Investigator Site 402
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigator Site 403
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Investigator Site 406
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Investigator Site 407
city: Buenos Aires
country: Argentina
facility: Investigator Site 401
city: San Juan
country: Argentina
facility: Investigator Site 408
city: Salvador
country: Brazil
facility: Investigator Site 504
state: Bahia
city: Goias
country: Brazil
facility: Investigator Site 509
state: Goiania
city: Goiania
country: Brazil
facility: Investigator Site 507
state: GO
city: Juiz de Fora
country: Brazil
facility: Investigator Site 506
state: MG
city: Porto Alegre
country: Brazil
facility: Investigator Site 512
state: Rio de Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Investigator Site 503
state: RJ
city: Porto Alegre
country: Brazil
facility: Investigator Site 502
state: RS
city: Campinas
country: Brazil
facility: Investigator Site 510
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Investigator Site 501
state: SP
city: Rio de Janeiro
country: Brazil
facility: Investigator Site 511
city: Sao Paulo
country: Brazil
facility: Investigator Site 505
city: Santiago de Chile
country: Chile
facility: Investigator Site 602
city: Santiago
country: Chile
facility: Investigator Site 605
city: Santiago
country: Chile
facility: Investigator Site 606
city: Vina del Mar
country: Chile
facility: Investigator Site 601
city: Medellin
country: Colombia
facility: Investigator Site 706
state: Antioquia
city: Medellin
country: Colombia
facility: Investigator Site 710
state: Antioquia
city: Barranquilla
country: Colombia
facility: Investigator Site 701
state: Atlantico
city: Barranquilla
country: Colombia
facility: Investigator Site 704
state: Atlántico
city: Bogota
country: Colombia
facility: Investigator Site 703
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Investigator Site 707
state: Santander
city: Bogota
country: Colombia
facility: Investigator Site 702
city: Bogota
country: Colombia
facility: Investigator Site 705
city: Bogota
country: Colombia
facility: Investigator Site 709
city: Bucaramanga
country: Colombia
facility: Investigator Site 711
city: Medellin
country: Colombia
facility: Investigator Site 708
city: New Territories
country: Hong Kong
facility: Investigator Site 153
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Investigator Site 151
city: Secunderabad
country: India
facility: Investigator Site 205
state: Andhra Pradesh
city: Bangalore
country: India
facility: Investigator Site 203
state: Kamataka
city: Trivandrum
country: India
facility: Investigator Site 204
state: Kerala
city: Mumbai
country: India
facility: Investigator Site 201
state: Maharashtra
city: Mexico City
country: Mexico
facility: Investigator Site 803
state: D.f.
city: Mexico
country: Mexico
facility: Inestigator Site 809
state: D.f.
city: Toluca
country: Mexico
facility: Investigator Site 802
state: Estado de Mexico
city: Guadalajara
country: Mexico
facility: Investigator Site 806
state: Jalisco
city: Morelia
country: Mexico
facility: Investigator Site 804
state: Michoacan
city: Guanajuato
country: Mexico
facility: Investigator Site 808
city: Mexico
country: Mexico
facility: Investigator Site 805
city: Mexico
country: Mexico
facility: Investigator Site 807
city: San Luis Potosi
country: Mexico
facility: Investigator Site 801
city: Cayma
country: Peru
facility: Investigator Site 901
state: Arequipa
city: Bellavista Callao
country: Peru
facility: Investigator Site 902
state: Callao
city: Lima
country: Peru
facility: Investigator Site 903
city: Lima
country: Peru
facility: Investigator Site 905
city: Lima
country: Peru
facility: Investigator Site 904
city: Davao City
country: Philippines
facility: Investigator Site 303
state: Davao
city: Manila City
country: Philippines
facility: Investigator Site 304
state: Metro Manila
city: Cebu
country: Philippines
facility: Investigator Site 302
city: Davao
country: Philippines
facility: Investigator Site 305
city: Taichung
country: Taiwan
facility: Investigator Site 354
city: Taichung
country: Taiwan
facility: Investigator Site 352
city: Taipei
country: Taiwan
facility: Investigator Site 351
Study officials:
References:
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.
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.