Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

NCT ID: NCT02265744

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-13
• Study Completion Date: 2017-11-30

Brief Summary

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

Detailed Description

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period

2. The LTE period will remain blinded but will no longer have a placebo arm:

• Subjects will remain on their originally assigned treatment arm unless they were on placebo
• Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks)

Conditions

Lupus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental:Arm A: BMS-931699

12.5mg subcutaneous (SC) injection Weekly dosing

Group Type: EXPERIMENTAL

BMS-931699

Intervention Type: DRUG

Experimental:Arm B: BMS-931699

12.5mg SC injection Every other Week dosing

Group Type: EXPERIMENTAL

BMS-931699

Intervention Type: DRUG

Experimental:Arm C: BMS-931699

5mg SC injection Every other Week dosing

Group Type: EXPERIMENTAL

BMS-931699

Intervention Type: DRUG

Experimental:Arm D: BMS-931699

1.25mg SC injection Every other Week dosing

Group Type: EXPERIMENTAL

BMS-931699

Intervention Type: DRUG

Placebo Comparator: Arm E: Placebo matching BMS-931699

0mg SC injection Weekly dosing

Group Type: PLACEBO_COMPARATOR

Placebo matching BMS-931699

Intervention Type: DRUG

Interventions

BMS-931699

Intervention Type: DRUG

Placebo matching BMS-931699

Intervention Type: DRUG

Other Intervention Names

lulizumab pegol

Eligibility Criteria

Inclusion Criteria

• Male or female aged between 18 to 70 (included)
• Diagnosed with active systemic lupus erythematosus by a doctor
• Disease must be in patient's joints or on the skin at a minimum
• Taking other medications is allowed but some are excluded

Exclusion Criteria

• Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
• Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama, United States

St Jude Hospital Yorba Linda

Fullerton, California, United States

Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

Long Beach, California, United States

Harbor UCLA Medical Center

Torrance, California, United States

University Of Connecticut Health Center

Farmington, Connecticut, United States

Local Institution

Trumbull, Connecticut, United States

Center For Rheumatology, Immunology And Arthritis

Fort Lauderdale, Florida, United States

The Arthritis Center

Palm Harbor, Florida, United States

Jefrey D. Lieberman, Md., Pc

Decatur, Georgia, United States

Coeur D'Alene Arthrit Clin

Coeur d'Alene, Idaho, United States

Heartland Research Associates, Llc

Wichita, Kansas, United States

Beth Israel Deaconess Med. Center Div. Of Gastroenterology

Boston, Massachusetts, United States

Physician Research Collaboration, Llc

Lincoln, Nebraska, United States

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

North Shore Lij Health System

Great Neck, New York, United States

The Feinstein Institute For Medical Research

Manhasset, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Joint and Muscle Medical Care and Research Institute (JMMCRI)

Charlotte, North Carolina, United States

Pmg Research Of Salisbury

Salisbury, North Carolina, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, United States

Allegheny-Singer Research Institute (Asri)

Pittsburgh, Pennsylvania, United States

Tekton Research Inc

Austin, Texas, United States

Local Institution

Dallas, Texas, United States

Arthritis Northwest

Spokane, Washington, United States

Local Institution

Capital Federal, Buenos Aires, Argentina

Hospital General De Agudos J.M. Ramos Mejia

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Instituto De Investigaciones Clinicas De Mar Del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto de Asistencia Reumatologica Integral

San Fernando, Buenos Aires, Argentina

Clinica De Reumatologia

Rosario, Santa Fe Province, Argentina

Centro Consultora Integral de Salud SRL

Córdoba, , Argentina

Servicos Especializados em Reumatologia SER

Savaldor, Estado de Bahia, Brazil

Cip Pesquisas Medicas

Goiânia, Goiás, Brazil

Centro Mineiro De Pesquisa

Juiz de Fora, Minas Gerais, Brazil

Centro Medico Varginha

Varginha, Minas Gerais, Brazil

Edumed - Educacao em Saude S/S LTDA

Curitiba, Paraná, Brazil

LMK Servicos Medicos S S Ltda

Porto Alegre, Rio Grande do Sul, Brazil

CPCLIN Centro de Pesquisas Clinicas LTDA

São Paulo, , Brazil

Lar Escola AACD

São Paulo, , Brazil

Karma Clinical Trials Inc.

St. John's, Newfoundland and Labrador, Canada

McMaster University

Hamilton, Ontario, Canada

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

CHU de Quebec Research Centre

Québec, Quebec, Canada

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec, Canada

Centro De Estudios Reumatologicos

Santiago, Santiago Metropolitan, Chile

Hospital San Borja Arriaran

Santiago, Santiago Metropolitan, Chile

Riesgo De Fractura

Bogota, Cundinamarca, Colombia

Servimed E.U

Bucaramanga, Santander Department, Colombia

Clinica De La Costa

Barranquilla, , Colombia

Hospital Pablo Tobon Uribe

Medellín, , Colombia

Local Institution

Bordeaux, , France

Local Institution

Lille, , France

Local Institution

Marseille, , France

Local Institution

Paris, , France

Local Institution

Strasbourg, , France

Campus Charite Mitte

Berlin, , Germany

Medizinsche Universitaetsklinik Freiburg

Freiburg im Breisgau, , Germany

Universitaetshautklinik Heidelberg

Heidelberg, , Germany

Johannes Gutenberg - Universitaet

Mainz, , Germany

Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Infektologiai-Hepatologiai Osztaly

Gyula, , Hungary

Borgyogyaszati Klinika

Szeged, , Hungary

Arcispedale S. Anna

Cona - Ferrara, , Italy

Azienda Ospedaliera Luigi Sacco

Milan, , Italy

Azienda Ospedaliera Di Padova

Padua, , Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Policlinico Umberto I

Roma, , Italy

Local Institution

Chiba, Chiba, Japan

Local Institution

Fukuoka, Fukuoka, Japan

Local Institution

Kitakyushu-shi, Fukuoka, Japan

Local Institution

Sapporo, Hokkaido, Japan

Local Institution

Sapporo, Hokkaido, Japan

Local Institution

Kanazawa, Ishikawa-ken, Japan

Local Institution

Sendai, Miyagi, Japan

Local Institution

Sasebo-shi, Nagasaki, Japan

Local Institution

Shimotsuke-shi, Tochigi, Japan

Local Institution

Bunkyo-ku, Tokyo, Japan

Local Institution

Chuo-ku, Tokyo, Japan

Local Institution

Fuchū, Tokyo, Japan

Local Institution

Itabashi-ku, Tokyo, Japan

Local Institution

Meguro-ku, Tokyo, Japan

Local Institution

Shinjuku-Ku, Tokyo, Japan

Local Institution

Beirut, , Lebanon

Local Institution

Tripoli, , Lebanon

CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

Mexico City, Distrito Fededral, Mexico

Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

León, Guanajuato, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, Mexico

Centro Integral En Reumatologia Sa De Cv

Guadalajara, Jalisco, Jalisco, Mexico

Instituto para el DeSarrollo Integral de la Salud S de RL de CV

Mexico City, Mexico City, Mexico

Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.

Villahermosa, Tabasco, Mexico

Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

Distrito Federal, , Mexico

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

San Luis Potosí City, , Mexico

Unidad Reumatologica Las Americas, S.C. P.

Yucatán, , Mexico

Local Institution

Groningen, , Netherlands

Local Institution

The Hague, , Netherlands

Clinica Anglo Americana

Lima, , Peru

Hospital Nacional Cayetano Heredia

Lima, , Peru

Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, , Peru

Local Institution

Lublin, , Poland

Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar

Poznan, , Poland

Local Institution

Warsaw, , Poland

Local Institution

San Juan, , Puerto Rico

Sf. Maria Clinical Hospital,Bucharest

Bucharest, , Romania

Spitalul Clinic de Recuperare Iasi

Iași, , Romania

Local Institution

Saint Petersburg, , Russia

Local Institution

Tolyatti, , Russia

Local Institution

Johannesburg, Gauteng, South Africa

Local Institution

Soweto, Gauteng, South Africa

Local Institution

Cape Town, Western Cape, South Africa

Local Institution

Stellenbosch, Western Cape, South Africa

Local Institution

Daejeon, , South Korea

Local Institution

Incheon, , South Korea

Local Institution

Seoul, , South Korea

Local Institution

Seoul, , South Korea

Hosp Univer 12 De Octubre

Madrid, , Spain

Hospital Carlos Haya De Malaga

Málaga, , Spain

Hospital Meixoeiro

Vigo, , Spain

Local Institution

Kaohsiung City, , Taiwan

Local Institution

Taichung, , Taiwan

Local Institution

Taipei, , Taiwan

Local Institution

Taoyuan District, , Taiwan

Countries

United States; Argentina; Brazil; Canada; Chile; Colombia; France; Germany; Hungary; Italy; Japan; Lebanon; Mexico; Netherlands; Peru; Poland; Puerto Rico; Romania; Russia; South Africa; South Korea; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 33687069 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

2014-002184-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM128-027

Identifier Type: -

Identifier Source: org_study_id