A Phase II Study of M2951 in SLE

Last updated: March 16, 2021
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Terminated

Phase

2

Condition

Musculoskeletal Diseases

Cutaneous Lupus Erythematosus

Systemic Lupus Erythematosus

Treatment

N/A

Clinical Study ID

NCT02975336
MS200527-0018
2016-002950-19
  • Ages 18-75
  • All Genders

Study Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible male and female participants, aged 18 to 75 years
  • Must have diagnosis of SLE with either the Systemic Lupus International CollaboratingClinics (SLICC) criteria for SLE, or at least four of the 11 American College ofRheumatology (ACR) classification criteria for SLE, of at least six months durationprior to Screening
  • SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAIgreater than or equal to (>=) 4) at Screening Visit
  • And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/oranti-nuclear antibody (ANA greater than or equal to (>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
  • Other protocol defined inclusion criteria could apply

Exclusion

Exclusion Criteria:

  • Participants are not eligible for this study if they have active, clinicallysignificant interstitial lung disease or pulmonary arterial hypertension
  • Proteinuria (urine protein to creatinine ratio [UPCR] > 4 mg/mg)
  • Acutely worsened renal function
  • Central nervous system SLE
  • Or within two weeks prior to Screening or during Screening: use of oralcorticosteroids greater than (>) 30 mg daily prednisone equivalent
  • Use of injectable corticosteroids, or change in dose of corticosteroids.
  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 469
Study Start date:
January 04, 2017
Estimated Completion Date:
March 23, 2020

Connect with a study center

  • Instituto de Investigaciones Clinicas

    Mar del Plata, Buenos Aires
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    San Miguel de Tucuman, Tucuman
    Argentina

    Site Not Available

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucuman, Tucuman
    Argentina

    Site Not Available

  • Centro Integral de Reumatologia

    San Miguel de Tucumán, Tucuman
    Argentina

    Site Not Available

  • Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • Clinica Adventista Belgrano

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • Hospital General de Agudos Dr. J. M. Ramos Mejia

    Ciudad Autonoma Buenos Aires,
    Argentina

    Site Not Available

  • APRILLUS

    Ciudad Autonoma Buenos aires,
    Argentina

    Site Not Available

  • Sanatorio Allende

    Cordoba,
    Argentina

    Site Not Available

  • Instituto de Reumatologia

    Mendoza,
    Argentina

    Site Not Available

  • Cordis S.A.

    Salta,
    Argentina

    Site Not Available

  • Centro Polivalente de Asistencia e Inv. Clinica CER

    San Juan,
    Argentina

    Site Not Available

  • UMHAT "Pulmed" OOD

    Plovdiv,
    Bulgaria

    Site Not Available

  • MHAT - Ruse, AD

    Ruse,
    Bulgaria

    Site Not Available

  • Medizinski Zentar-1-Sevlievo EOOD

    Sevlievo,
    Bulgaria

    Site Not Available

  • Medical Center "Excelsior", OOD

    Sofia,
    Bulgaria

    Site Not Available

  • Medical Center Comac Medical EOOD

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT "SofiaMed", OOD

    Sofia,
    Bulgaria

    Site Not Available

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia,
    Bulgaria

    Site Not Available

  • Corporacion de Beneficencia Osorno

    Osorno,
    Chile

    Site Not Available

  • Centro Medico Prosalud

    Santiago,
    Chile

    Site Not Available

  • Centro de Estudios Reumatologicos

    Santiago,
    Chile

    Site Not Available

  • Interin

    Santiago,
    Chile

    Site Not Available

  • Psicomedica Clinical and Research Group

    Santiago,
    Chile

    Site Not Available

  • Quantum Research Santiago

    Santiago,
    Chile

    Site Not Available

  • Centro de Reumatologia y Ortopedia SAS

    Barranquilla,
    Colombia

    Site Not Available

  • Clínica de la Costa Ltda.

    Barranquilla,
    Colombia

    Site Not Available

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogota,
    Colombia

    Site Not Available

  • Simedics Ips Sas

    Bogotá,
    Colombia

    Site Not Available

  • Servimed S.A.S.

    Bucaramanga,
    Colombia

    Site Not Available

  • CIRI - Centrum für Innovative Diagnostik und Therapie GmbH

    Frankfurt, Hessen
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Koeln, Nordrhein Westfalen
    Germany

    Site Not Available

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin,
    Germany

    Site Not Available

  • For Recruiting Locations outside US, please Contact Merck KGaA Communication Center

    Darmstadt,
    Germany

    Site Not Available

  • Asklepios Klinik Altona

    Hamburg,
    Germany

    Site Not Available

  • Humanitas Research Hospital

    Rozzano, Milano
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Napoli,
    Italy

    Site Not Available

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia,
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma,
    Italy

    Site Not Available

  • Ehime University Hospital

    Toon-shi, Ehime-Ken
    Japan

    Site Not Available

  • Tobata General Hospital

    Kitakyushu-shi, Fukuoka-Ken
    Japan

    Site Not Available

  • University of Occupational and Environmental Health Hospital

    Kitakyushu-shi, Fukuoka-Ken
    Japan

    Site Not Available

  • NHO Asahikawa Medical Center

    Asahikawa-shi, Hokkaido
    Japan

    Site Not Available

  • Kanazawa University Hospital

    Kanazawa-shi, Ishikawa-Ken
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita-gun, Kagawa-Ken
    Japan

    Site Not Available

  • Eiraku Clinic

    Kagoshima-shi, Kagoshima-Ken
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi, Miyagi-Ken
    Japan

    Site Not Available

  • Seirei Hamamatsu General Hospital

    Hamamatsu-shi, Shizuoka-Ken
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi-Ken
    Japan

    Site Not Available

  • St. Luke's International Hospital

    Chuo-ku, Tokyo-To
    Japan

    Site Not Available

  • Tokyo Metropolitan Tama Medical Center

    Fuchu-shi, Tokyo-To
    Japan

    Site Not Available

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo-To
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku, Tokyo-To
    Japan

    Site Not Available

  • Tottori University Hospital

    Yonago-shi, Tottori-Ken
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Hospital Pakar Sultanah Fatimah

    Muar, Johor
    Malaysia

    Site Not Available

  • Hospital Umum Sarawak

    Kuching, Sarawak
    Malaysia

    Site Not Available

  • Hospital Selayang

    Batu Caves, Selangor
    Malaysia

    Site Not Available

  • International Medical University (IMU) Healthcare

    Bukit Jalil, Selangor
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • CAP Research

    Solferino-Phoenix,
    Mauritius

    Site Not Available

  • Unidad de Investigacion de las Enfermedades Reumaticas

    Cuauhtemoc, Distrito Federal
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    Mexico, Distrito Federal
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla, Estado De Mexico
    Mexico

    Site Not Available

  • Morales Vargas Centro de Investigacion, S.C.

    Leon, Guanajuato
    Mexico

    Site Not Available

  • Clinica de Investigacion en Reumatologia y Obesidad S.C.

    Guadalajara, Jalisco
    Mexico

    Site Not Available

  • Unidad de Investigacion en Enfermedades Cronico Degenerativas SC

    Guadalajara, Jalisco
    Mexico

    Site Not Available

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León
    Mexico

    Site Not Available

  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosi, San Luis Potos
    Mexico

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua, S.C.

    Chihuahua,
    Mexico

    Site Not Available

  • Hogar Clínica San Juan de Dios - Arequipa

    Arequipa,
    Peru

    Site Not Available

  • Clinica El Golf

    Lima,
    Peru

    Site Not Available

  • Clinica Medica Cayetano Heredia

    Lima,
    Peru

    Site Not Available

  • Clinica San Juan Bautista

    Lima,
    Peru

    Site Not Available

  • Clinica Vesalio

    Lima,
    Peru

    Site Not Available

  • GINOBS SA. Instituto de Ginecologia y Reproduccion

    Lima,
    Peru

    Site Not Available

  • Hospital Nacional Cayetano Heredia

    Lima,
    Peru

    Site Not Available

  • University of Washington Medical Center

    Lima,
    Peru

    Site Not Available

  • ICCV Research Instituto del Cerebro y la Columna Vertebral

    Miraflores,
    Peru

    Site Not Available

  • Angeles University Foundation Medical Center

    Angeles City, Pampanga,
    Philippines

    Site Not Available

  • Mary Mediatrix Medical Center

    Batangas,
    Philippines

    Site Not Available

  • De La Salle University Medical Center

    Dasmariñas City, Cavite,
    Philippines

    Site Not Available

  • Davao Doctors Hospital

    Davao City,
    Philippines

    Site Not Available

  • Southern Philippines Medical Center

    Davao City,
    Philippines

    Site Not Available

  • Iloilo Doctors Hospital

    Iloilo City,
    Philippines

    Site Not Available

  • St. Luke's Medical Center

    Quezon City,
    Philippines

    Site Not Available

  • CERMED

    Bialystok,
    Poland

    Site Not Available

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz,
    Poland

    Site Not Available

  • Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela

    Elblag,
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow,
    Poland

    Site Not Available

  • Nzoz Atopia

    Krakow,
    Poland

    Site Not Available

  • Rheuma Medicus Zaklad

    Warsawa,
    Poland

    Site Not Available

  • Spitalul Clinic "Dr.I. Cantacuzino"

    Bucuresti,
    Romania

    Site Not Available

  • Spitalul Clinic "Sf. Maria"

    Bucuresti,
    Romania

    Site Not Available

  • S.C Mediab S.R.L

    Tirgu Mures,
    Romania

    Site Not Available

  • LLC "Alliance Biomedical - Ural Group"

    Izhevsk,
    Russian Federation

    Site Not Available

  • TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

    Krasnoyarsk,
    Russian Federation

    Site Not Available

  • BMI "Kursk Regional Clinical Hospital"

    Kursk,
    Russian Federation

    Site Not Available

  • HMA - Hospital Maria Auxiliadora

    Moscow,
    Russian Federation

    Site Not Available

  • Ultramed

    Omsk,
    Russian Federation

    Site Not Available

  • LLC Medical Sanitary Unit#157

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • SPb SBIH "Clinical Rheumatological Hospital # 25"

    Saint-Petersburg,
    Russian Federation

    Site Not Available

  • SIH "Saratov City Clinical Hospital # 12"

    Saratov,
    Russian Federation

    Site Not Available

  • Research Institute of Emergency Medical Care

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Nebbiolo LLC

    Tomsk,
    Russian Federation

    Site Not Available

  • Wits Clinical Research

    Johannesburg, Gauteng
    South Africa

    Site Not Available

  • Winelands Medical Research Centre

    Stellenbosch, Western Cape
    South Africa

    Site Not Available

  • Naidoo, A - Netcare Umhlanga Hospital

    Durban, 4319
    South Africa

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Pinnacle Research Group LLC

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • Wallace Rheumatic Study Center

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91722
    United States

    Site Not Available

  • Southern California Permanent Medical Group

    Fontana, California 92335
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Arthritis/Osteoporosis Med Ctr

    La Palma, California
    United States

    Site Not Available

  • Advanced Medical Research, LLC

    Lakewood, California
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Southern California Permanent Medical Group

    San Diego, California
    United States

    Site Not Available

  • East Bay Rheumatology Medical Group, Inc.

    San Leandro, California 94578
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California 91786
    United States

    Site Not Available

  • Nazanin Firooz, MD Inc.

    West Hills, California 91307
    United States

    Site Not Available

  • University of Colorado Denver Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Yale School Of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Clinical Research of West Florida - Corporate

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Site Not Available

  • Center for Rheumatology, Immunology & Arthritis

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • Center for Rheumatology, Immunology & Arthritis

    Ft. Lauderdale, Florida
    United States

    Site Not Available

  • Hope Clinical Trials

    Miami, Florida 33165
    United States

    Site Not Available

  • IRIS Research and Development

    Plantation, Florida 33324
    United States

    Site Not Available

  • McIlwain Medical Group, PA

    Tampa, Florida 33614
    United States

    Site Not Available

  • Meridien Research, Inc.

    Tampa, Florida 33634
    United States

    Site Not Available

  • Marietta Rheumatology Associates, PC

    Marietta, Georgia 30060
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • LSU Health Sciences Center Gastroenterology

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • For Recruiting Locations in the US contact US Medical Information in

    Rockland, Massachusetts
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • AA MRC LLC Ahmed Arif Medical Research Center

    Flint, Michigan 48439
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Montefiore Medical Center PRIME

    Bronx, New York 10461
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • SUNY Upstate Medical Center

    Syracuse, New York 13210
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Medication Management, LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Shanahan Rheumatology & Immunotherapy, PLLC

    Raleigh, North Carolina
    United States

    Site Not Available

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Innovative Clinical Research, LLC

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Metroplex Clinical Research Center, LLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • Accurate Clinical Management - Brionez

    Houston, Texas 77084
    United States

    Site Not Available

  • Accurate Clinical Research, Inc.

    Houston, Texas 77034
    United States

    Site Not Available

  • Medical Center Research, LLC Webster Office

    Pearland, Texas 77584
    United States

    Site Not Available

  • Accurate Clinical Management - Brionez

    The Woodlands, Texas
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Medical Center Research, LLC

    Webster, Texas
    United States

    Site Not Available

  • FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

    Seattle, Washington
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.