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

Systemic Lupus Erythematosus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162681
• Other study ID #: AN-SLE3321
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2010
• Last updated: January 30, 2014
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2014
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosIndia: Drugs Controller General of IndiaMexico: Federal Commission for Protection Against Health RisksPeru: Instituto Nacional de SaludPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• A-623
High dose given subcutaneously once a week for up to 52 weeks
• A-623
Low dose given subcutaneously once a week for up to 52 weeks
• A-623
High dose given subcutaneously once every 4 weeks for up to 52 weeks

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

Locations

Country	Name	City	State
Argentina	Investigator Site 401	Buenos Aires
Argentina	Investigator Site 407	Buenos Aires
Argentina	Investigator Site 402	Caba	Buenos Aires
Argentina	Investigator Site 404	Caba	Buenos Aires
Argentina	Investigator Site 403	Rosario	Santa Fe
Argentina	Investigator Site 408	San Juan
Argentina	Investigator Site 406	San Miguel de Tucuman	Tucuman
Brazil	Investigator Site 510	Campinas	Sao Paulo
Brazil	Investigator Site 507	Goiania	GO
Brazil	Investigator Site 509	Goias	Goiania
Brazil	Investigator Site 506	Juiz de Fora	MG
Brazil	Investigator Site 502	Porto Alegre	RS
Brazil	Investigator Site 512	Porto Alegre	Rio de Grande do Sul
Brazil	Investigator Site 503	Rio de Janeiro	RJ
Brazil	Investigator Site 511	Rio de Janeiro
Brazil	Investigator Site 504	Salvador	Bahia
Brazil	Investigator Site 501	Sao Paulo	SP
Brazil	Investigator Site 505	Sao Paulo
Chile	Investigator Site 605	Santiago
Chile	Investigator Site 606	Santiago
Chile	Investigator Site 602	Santiago de Chile
Chile	Investigator Site 601	Vina del Mar
Colombia	Investigator Site 701	Barranquilla	Atlantico
Colombia	Investigator Site 704	Barranquilla	Atlántico
Colombia	Investigator Site 702	Bogota
Colombia	Investigator Site 703	Bogota	Cundinamarca
Colombia	Investigator Site 705	Bogota
Colombia	Investigator Site 709	Bogota
Colombia	Investigator Site 707	Bucaramanga	Santander
Colombia	Investigator Site 711	Bucaramanga
Colombia	Investigator Site 706	Medellin	Antioquia
Colombia	Investigator Site 708	Medellin
Colombia	Investigator Site 710	Medellin	Antioquia
Hong Kong	Investigator Site 151	Hong Kong
Hong Kong	Investigator Site 153	New Territories	Shatin
India	Investigator Site 203	Bangalore	Kamataka
India	Investigator Site 201	Mumbai	Maharashtra
India	Investigator Site 205	Secunderabad	Andhra Pradesh
India	Investigator Site 204	Trivandrum	Kerala
Mexico	Investigator Site 806	Guadalajara	Jalisco
Mexico	Investigator Site 808	Guanajuato
Mexico	Inestigator Site 809	Mexico	D.f.
Mexico	Investigator Site 805	Mexico
Mexico	Investigator Site 807	Mexico
Mexico	Investigator Site 803	Mexico City	D.f.
Mexico	Investigator Site 804	Morelia	Michoacan
Mexico	Investigator Site 801	San Luis Potosi
Mexico	Investigator Site 802	Toluca	Estado de Mexico
Peru	Investigator Site 902	Bellavista Callao	Callao
Peru	Investigator Site 901	Cayma	Arequipa
Peru	Investigator Site 903	Lima
Peru	Investigator Site 904	Lima
Peru	Investigator Site 905	Lima
Philippines	Investigator Site 302	Cebu
Philippines	Investigator Site 305	Davao
Philippines	Investigator Site 303	Davao City	Davao
Philippines	Investigator Site 304	Manila City	Metro Manila
Taiwan	Investigator Site 352	Taichung
Taiwan	Investigator Site 354	Taichung
Taiwan	Investigator Site 351	Taipei
United States	Investigator Site 117	Baltimore	Maryland
United States	Investigator Site 103	Birmingham	Alabama
United States	Investigator Site 101	Greenville	North Carolina
United States	Investigator Site 115	Houston	Texas
United States	Investigator Site 106	Lake Success	New York
United States	Investigator Site 104	Lansing	Michigan
United States	Investigator Site 113	Long Beach	California
United States	Investigator Site 108	Los Angeles	California
United States	Investigator Site 112	Oklahoma City	Oklahoma
United States	Investigator Site 105	Orlando	Florida
United States	Investigator Site 114	Smithtown	New York
United States	Investigator Site 102	Tampa	Florida
United States	Investigator Site 111	Tulsa	Oklahoma
United States	Investigator Site 110	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  Colombia,  Hong Kong,  India,  Mexico,  Peru,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SLE response	The % of subjects with SLE response compared with baseline at the time of assessment	Various timepoints through Week 52	No
Secondary	B cell reduction		Various timepoints through Week 52	No
Secondary	Time to first flare		Various timepoints through Week 52	No
Secondary	FACIT-fatigue score		Various timepoints through Week 52	No
Secondary	Reduction in prednisone dose		Various timepoints through Week 52	No
Secondary	Change in IgG, IgM,C3 and C4		Various timepoints through Week 52	No
Secondary	Flare rates		Various timepoints through Week 52	No
Secondary	SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9		Various timepoints through Week 52	No