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

NCT01162681 | Completed Phase 2 DMC

• 1 other identifier: AN-SLE3321
• Study Type: interventional
• Target: 547
• Locations: 11 countries
• Sites: 74

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

Conditions

Systemic Lupus Erythematosus

Keywords

SLE; Lupus; Lupus Erythematosus, Systemic; Autoimmune Diseases; A-623; Blisibimod

Outcome Measures

Primary Outcomes (1)

• SLE response

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

  Various timepoints through Week 52

Secondary Outcomes (7)

• B cell reduction

  Various timepoints through Week 52

• Time to first flare

  Various timepoints through Week 52

• FACIT-fatigue score

  Various timepoints through Week 52

• Reduction in prednisone dose

  Various timepoints through Week 52

• Change in IgG, IgM,C3 and C4

  Various timepoints through Week 52

Study Arms (4)

A-623 high dose weekly

EXPERIMENTAL

Drug: A-623

A-623 low dose weekly

EXPERIMENTAL

Drug: A-623

A-623 high dose every 4 weeks

EXPERIMENTAL

Drug: A-623

Placebo

PLACEBO COMPARATOR

Other: Placebo Comparator

Interventions

A-623 DRUG

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

A-623 high dose weekly

Placebo Comparator OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SLE by American College of Rheumatology guidelines.
• On stable SLE treatment
• Active SLE disease
• Serologically active
• years of age or older
• Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

You may not qualify if:

• 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

Sponsors & Collaborators

• Anthera Pharmaceuticals: lead

Study Sites (74)

Investigator Site 103

Birmingham, Alabama, 35294, United States

Location

Investigator Site 113

Long Beach, California, 90806, United States

Location

Investigator Site 108

Los Angeles, California, 90095, United States

Location

Investigator Site 110

Upland, California, 91786, United States

Location

Investigator Site 105

Orlando, Florida, 32806, United States

Location

Investigator Site 102

Tampa, Florida, 33614, United States

Location

Investigator Site 117

Baltimore, Maryland, 21205, United States

Location

Investigator Site 104

Lansing, Michigan, 48910, United States

Location

Investigator Site 106

Lake Success, New York, 11042, United States

Location

Investigator Site 114

Smithtown, New York, 11787, United States

Location

Investigator Site 101

Greenville, North Carolina, 27834, United States

Location

Investigator Site 112

Oklahoma City, Oklahoma, 73104, United States

Location

Investigator Site 111

Tulsa, Oklahoma, 74104, United States

Location

Investigator Site 115

Houston, Texas, 77034, United States

Location

Investigator Site 404

Caba, Buenos Aires, C1015ABO, Argentina

Location

Investigator Site 402

Caba, Buenos Aires, C1280AEB, Argentina

Location

Investigator Site 408

San Juan, San Juan Province, 5400, Argentina

Location

Investigator Site 403

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

Investigator Site 406

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Investigator Site 407

Buenos Aires, C1121ABE, Argentina

Location

Investigator Site 401

Buenos Aires, C1431FWO, Argentina

Location

Investigator Site 504

Salvador, Estado de Bahia, 40050-010, Brazil

Location

Investigator Site 509

Goiás, Goiania, 74605-050, Brazil

Location

Investigator Site 507

Goiânia, Goiás, 74110120, Brazil

Location

Investigator Site 506

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Investigator Site 512

Porto Alegre, Rio de Grande Do Sul, 90035-903, Brazil

Location

Investigator Site 503

Rio de Janeiro, Rio de Janeiro, 21941, Brazil

Location

Investigator Site 502

Porto Alegre, Rio Grande do Sul, 9061-0000, Brazil

Location

Investigator Site 510

Campinas, São Paulo, 13015, Brazil

Location

Investigator Site 505

São Paulo, São Paulo, 04038-004, Brazil

Location

Investigator Site 501

São Paulo, São Paulo, 04039-901, Brazil

Location

Investigator Site 511

Rio de Janeiro, 20551, Brazil

Location

Investigator Site 606

Santiago, Chile, Chile

Location

Investigator Site 602

Santiago, 8330033, Chile

Location

Investigator Site 605

Santiago, Chile

Location

Investigator Site 601

Viña del Mar, 2570017, Chile

Location

Investigator Site 706

Medellín, Antioquia, Colombia

Location

Investigator Site 710

Medellín, Antioquia, Colombia

Location

Investigator Site 701

Barranquilla, Atlántico, Colombia

Location

Investigator Site 704

Barranquilla, Atlántico, Colombia

Location

Investigator Site 703

Bogota, Cundinamarca, Colombia

Location

Investigator Site 707

Bucaramanga, Santander Department, Colombia

Location

Investigator Site 702

Bogotá, Colombia

Location

Investigator Site 705

Bogotá, Colombia

Location

Investigator Site 709

Bogotá, Colombia

Location

Investigator Site 711

Bucaramanga, Colombia

Location

Investigator Site 708

Medellín, Colombia

Location

Investigator Site 153

New Territories, Shatin, Hong Kong

Location

Investigator Site 151

Hong Kong, Hong Kong

Location

Investigator Site 205

Secunderabad, Andhra Pradesh, 500003, India

Location

Investigator Site 203

Bangalore, Kamataka, 560034, India

Location

Investigator Site 204

Trivandrum, Kerala, 695011, India

Location

Investigator Site 201

Mumbai, Maharashtra, 400012, India

Location

Investigator Site 803

Mexico City, D.f., 06726, Mexico

Location

Inestigator Site 809

México, D.f., 14000, Mexico

Location

Investigator Site 806

Guadalajara, Jalisco, 44280, Mexico

Location

Investigator Site 804

Morelia, Michoacán, 58070, Mexico

Location

Investigator Site 801

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Investigator Site 802

Toluca, State of Mexico, 50120, Mexico

Location

Investigator Site 808

Guanajuato City, Mexico

Location

Investigator Site 805

México, Mexico

Location

Investigator Site 807

México, Mexico

Location

Investigator Site 901

Cayma, Arequipa, Peru

Location

Investigator Site 903

Lima, Lima Province, L-01, Peru

Location

Investigator Site 905

Lima, Lima Province, L27, Peru

Location

Investigator Site 904

Lima, Lima Province, Peru

Location

Investigator Site 902

Bellavista Callao, Provincia Constitucional del Callao, Peru

Location

Investigator Site 302

Cebu, Cebu, 6000, Philippines

Location

Investigator Site 303

Davao City, Davao Region, 8000, Philippines

Location

Investigator Site 304

Manila, National Capital Region, 1008, Philippines

Location

Investigator Site 305

Davao City, 8000, Philippines

Location

Investigator Site 354

Taichung, 402, Taiwan

Location

Investigator Site 352

Taichung, 414, Taiwan

Location

Investigator Site 351

Taipei, 100, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 33687069 DERIVED

• 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.

  PMID: 24748629 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

AMG623 peptibody

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 4, 2014

Record last verified: 2014-01

Locations

IN (4); CO (11); TW (3); HK (2); US (14); BR (11); CL (4); ME (9); PE (5); PH (4); AR (7)