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

NCT02265744 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IM128-0272014-002184-14
• Study Type: interventional
• Target: 730
• Locations: 23 countries
• Sites: 121

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.

Conditions

Lupus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169

  The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline.

  At Day 169

Secondary Outcomes (33)

• Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169

  At Day 169

• Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85

  At Day 85

• Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85

  At Day 85

• Mean Change From Baseline in CLASI Score at Day 85 and Day 169

  At Day 85 and Day 169

• Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score

  At Day 85 and Day 169

Study Arms (5)

Experimental:Arm A: BMS-931699

EXPERIMENTAL

12.5mg subcutaneous (SC) injection Weekly dosing

Drug: BMS-931699

Experimental:Arm B: BMS-931699

EXPERIMENTAL

12.5mg SC injection Every other Week dosing

Drug: BMS-931699

Experimental:Arm C: BMS-931699

EXPERIMENTAL

5mg SC injection Every other Week dosing

Drug: BMS-931699

Experimental:Arm D: BMS-931699

EXPERIMENTAL

1.25mg SC injection Every other Week dosing

Drug: BMS-931699

Placebo Comparator: Arm E: Placebo matching BMS-931699

PLACEBO COMPARATOR

0mg SC injection Weekly dosing

Drug: Placebo matching BMS-931699

Interventions

BMS-931699 DRUG

Also known as: lulizumab pegol

Experimental:Arm A: BMS-931699; Experimental:Arm B: BMS-931699; Experimental:Arm C: BMS-931699; Experimental:Arm D: BMS-931699

Placebo matching BMS-931699 DRUG

Placebo Comparator: Arm E: Placebo matching BMS-931699

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (121)

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama, 35801, United States

Location

St Jude Hospital Yorba Linda

Fullerton, California, 92835, United States

Location

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

Long Beach, California, 90806, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

University Of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Local Institution

Trumbull, Connecticut, 06611, United States

Location

Center For Rheumatology, Immunology And Arthritis

Fort Lauderdale, Florida, 33309, United States

Location

The Arthritis Center

Palm Harbor, Florida, 34684-3176, United States

Location

Jefrey D. Lieberman, Md., Pc

Decatur, Georgia, 30033, United States

Location

Coeur D'Alene Arthrit Clin

Coeur d'Alene, Idaho, 83814-2644, United States

Location

Heartland Research Associates, Llc

Wichita, Kansas, 67207-5150, United States

Location

Beth Israel Deaconess Med. Center Div. Of Gastroenterology

Boston, Massachusetts, 02215, United States

Location

Physician Research Collaboration, Llc

Lincoln, Nebraska, 68516, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102-2631, United States

Location

North Shore Lij Health System

Great Neck, New York, 11021, United States

Location

The Feinstein Institute For Medical Research

Manhasset, New York, 11030, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Joint and Muscle Medical Care and Research Institute (JMMCRI)

Charlotte, North Carolina, 28204, United States

Location

Pmg Research Of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

East Penn Rheumatology Associates, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Allegheny-Singer Research Institute (Asri)

Pittsburgh, Pennsylvania, 15224, United States

Location

Tekton Research Inc

Austin, Texas, 78745, United States

Location

Local Institution

Dallas, Texas, 75246, United States

Location

Arthritis Northwest

Spokane, Washington, 99204, United States

Location

Local Institution

Capital Federal, Buenos Aires, 1431, Argentina

Location

Hospital General De Agudos J.M. Ramos Mejia

Ciudad Autonoma de Buenos Aire, Buenos Aires, 1221, Argentina

Location

Instituto De Investigaciones Clinicas De Mar Del Plata

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Instituto de Asistencia Reumatologica Integral

San Fernando, Buenos Aires, 1646, Argentina

Location

Clinica De Reumatologia

Rosario, Santa Fe Province, 2000, Argentina

Location

Centro Consultora Integral de Salud SRL

Córdoba, 5004, Argentina

Location

Servicos Especializados em Reumatologia SER

Savaldor, Estado de Bahia, 40150-150, Brazil

Location

Cip Pesquisas Medicas

Goiânia, Goiás, 74110-120, Brazil

Location

Centro Mineiro De Pesquisa

Juiz de Fora, Minas Gerais, 36010570, Brazil

Location

Centro Medico Varginha

Varginha, Minas Gerais, 37006-710, Brazil

Location

Edumed - Educacao em Saude S/S LTDA

Curitiba, Paraná, 80440-210, Brazil

Location

LMK Servicos Medicos S S Ltda

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

CPCLIN Centro de Pesquisas Clinicas LTDA

São Paulo, 01244-030, Brazil

Location

Lar Escola AACD

São Paulo, 04032-060, Brazil

Location

Karma Clinical Trials Inc.

St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

CHU de Quebec Research Centre

Québec, Quebec, G1V 4G2, Canada

Location

Centre De Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Centro De Estudios Reumatologicos

Santiago, Santiago Metropolitan, 7501126, Chile

Location

Hospital San Borja Arriaran

Santiago, Santiago Metropolitan, 8360156, Chile

Location

Riesgo De Fractura

Bogota, Cundinamarca, Colombia

Location

Servimed E.U

Bucaramanga, Santander Department, Colombia

Location

Clinica De La Costa

Barranquilla, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, MEDELLIN, Colombia

Location

Local Institution

Bordeaux, 33076, France

Location

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Lille, 59037, France

Location

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Marseille, 13003, France

Location

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Paris, 75651, France

Location

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Strasbourg, 67098, France

Location

Campus Charite Mitte

Berlin, 10117, Germany

Location

Medizinsche Universitaetsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitaetshautklinik Heidelberg

Heidelberg, 69120, Germany

Location

Johannes Gutenberg - Universitaet

Mainz, 55131, Germany

Location

Budai Irgalmasrendi Korhaz

Budapest, 1027, Hungary

Location

Infektologiai-Hepatologiai Osztaly

Gyula, 5700, Hungary

Location

Borgyogyaszati Klinika

Szeged, 6720, Hungary

Location

Arcispedale S. Anna

Cona - Ferrara, 44124, Italy

Location

Azienda Ospedaliera Luigi Sacco

Milan, 20154, Italy

Location

Azienda Ospedaliera Di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

Location

Policlinico Umberto I

Roma, 00185, Italy

Location

Local Institution

Chiba, Chiba, 2608677, Japan

Location

Local Institution

Fukuoka, Fukuoka, 8128582, Japan

Location

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Kitakyushu-shi, Fukuoka, 8078555, Japan

Location

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Sapporo, Hokkaido, 0608604, Japan

Location

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Sapporo, Hokkaido, 0608648, Japan

Location

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Kanazawa, Ishikawa-ken, 9208641, Japan

Location

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Sendai, Miyagi, 9808574, Japan

Location

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Sasebo-shi, Nagasaki, 8571195, Japan

Location

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Shimotsuke-shi, Tochigi, 3290498, Japan

Location

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Bunkyo-ku, Tokyo, 1138655, Japan

Location

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Chuo-ku, Tokyo, 1048560, Japan

Location

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Fuchū, Tokyo, 1838524, Japan

Location

Local Institution

Itabashi-ku, Tokyo, 1738610, Japan

Location

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Meguro-ku, Tokyo, 1538515, Japan

Location

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Shinjuku-Ku, Tokyo, 1608582, Japan

Location

Local Institution

Beirut, Lebanon

Location

Local Institution

Tripoli, Lebanon

Location

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

Mexico City, Distrito Fededral, 11850, Mexico

Location

Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

León, Guanajuato, 37000, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S.C.

Guadalajara, Jalisco, 44650, Mexico

Location

Centro Integral En Reumatologia Sa De Cv

Guadalajara, Jalisco, Jalisco, 44160, Mexico

Location

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

Mexico City, Mexico City, 06700, Mexico

Location

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

Villahermosa, Tabasco, 86190, Mexico

Location

Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

Distrito Federal, 14080, Mexico

Location

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

San Luis Potosí City, 78213, Mexico

Location

Unidad Reumatologica Las Americas, S.C. P.

Yucatán, 97000, Mexico

Location

Local Institution

Groningen, 9700 RB, Netherlands

Location

Local Institution

The Hague, 2545 CH, Netherlands

Location

Clinica Anglo Americana

Lima, 27, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, LIMA 31, Peru

Location

Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, LIMA 33, Peru

Location

Local Institution

Lublin, 20-954, Poland

Location

Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar

Poznan, 60-218, Poland

Location

Local Institution

Warsaw, 00-465, Poland

Location

Local Institution

San Juan, 00918, Puerto Rico

Location

Sf. Maria Clinical Hospital,Bucharest

Bucharest, 011192, Romania

Location

Spitalul Clinic de Recuperare Iasi

Iași, 700661, Romania

Location

Local Institution

Saint Petersburg, 191124, Russia

Location

Local Institution

Tolyatti, 445039, Russia

Location

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Johannesburg, Gauteng, South Africa

Location

Local Institution

Soweto, Gauteng, 2013, South Africa

Location

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Cape Town, Western Cape, 7500, South Africa

Location

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Stellenbosch, Western Cape, 7600, South Africa

Location

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Daejeon, 35015, South Korea

Location

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Incheon, 22332, South Korea

Location

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Seoul, 04763, South Korea

Location

Local Institution

Seoul, 07345, South Korea

Location

Hosp Univer 12 De Octubre

Madrid, 28041, Spain

Location

Hospital Carlos Haya De Malaga

Málaga, 29010, Spain

Location

Hospital Meixoeiro

Vigo, 36241, Spain

Location

Local Institution

Kaohsiung City, 833, Taiwan

Location

Local Institution

Taichung, 40447, Taiwan

Location

Local Institution

Taipei, 100, Taiwan

Location

Local Institution

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Interventions

lulizumab pegol

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 16, 2014
• Study Start: November 13, 2014
• Primary Completion: October 26, 2017
• Study Completion: November 30, 2017
• Last Updated: October 7, 2019
• Results First Posted: January 4, 2019

Record last verified: 2019-10

Locations

AR (6); CL (2); LE (2); RO (2); BR (8); JP (15); ME (9); ES (3); PL (3); PE (3); KR (4); IT (5); US (25); TW (4); FR (5); CO (4); DE (4); PR (1); CA (5); NL (2); HU (3); ZA (4); RU (2)