A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)
Study Purpose
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study is to assess the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE)
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 75 Years |
| Gender | All |
Inclusion Criteria:
- - Eligible male and female subjects, aged 18 to 75 years - Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening - SLEDAI-2K total score greater than or equal to (>=) 6 (including clinical SLEDAI greater than or equal to (>=) 4) at Screening Visit - And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-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 Criteria:
- - Subjects are not eligible for this study if they have active, clinically significant 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 oral corticosteroids greater than (>) 30 mg daily prednisone equivalent - Use of injectable corticosteroids, or change in dose of corticosteroids.
- - Other protocol defined exclusion criteria could apply.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02975336 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
EMD Serono Research & Development Institute, Inc. |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Medical Responsible |
| Principal Investigator Affiliation | EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Bulgaria, Chile, Colombia, Germany, Italy, Japan, Korea, Republic of, Malaysia, Mauritius, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Taiwan, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Pinnacle Research Group LLC
Anniston, Alabama,
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona,
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona,
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona,
Status
Active, not recruiting
Address
Advanced Research Center, Inc.
Anaheim, California,
Status
Completed
Address
Medvin Clinical Research
Covina, California,
Status
Active, not recruiting
Address
Global Research Management
Glendale, California,
Status
Withdrawn
Address
Arthritis/Osteoporosis Med Ctr
La Palma, California,
Status
Withdrawn
Address
Advanced Medical Research, LLC
Lakewood, California,
Status
Active, not recruiting
Address
University of Southern California
Los Angeles, California,
Status
Active, not recruiting
Address
Wallace Rheumatic Study Center
Los Angeles, California,
Status
Completed
Address
Southern California Permanent Medical Group
San Diego, California,
Status
Completed
Address
East Bay Rheumatology Medical Group, Inc.
San Leandro, California,
Status
Active, not recruiting
Address
Inland Rheumatology Clinical Trials, Inc.
Upland, California,
Status
Completed
Address
Nazanin Firooz, MD Inc.
West Hills, California,
Status
Active, not recruiting
Address
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado,
Status
Active, not recruiting
Address
Yale School Of Medicine
New Haven, Connecticut,
Status
Active, not recruiting
Address
Clinical Research of West Florida - Corporate
Clearwater, Florida,
Status
Active, not recruiting
Address
Omega Research Consultants
DeBary, Florida,
Status
Active, not recruiting
Address
Center for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida,
Status
Active, not recruiting
Address
Hope Clinical Trials
Miami, Florida,
Status
Active, not recruiting
Address
IRIS Research and Development
Plantation, Florida,
Status
Active, not recruiting
Address
McIlwain Medical Group, PA
Tampa, Florida,
Status
Suspended
Address
Meridien Research, Inc.
Tampa, Florida,
Status
Active, not recruiting
Address
Marietta Rheumatology Associates, PC
Marietta, Georgia,
Status
Active, not recruiting
Address
The University of Chicago Medicine
Chicago, Illinois,
Status
Completed
Address
LSU Health Sciences Center Gastroenterology
Shreveport, Louisiana,
Status
Completed
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts,
Status
Withdrawn
Address
Great Lakes Research Group, Inc.
Bay City, Michigan,
Status
Active, not recruiting
Address
Henry Ford Health System
Detroit, Michigan,
Status
Active, not recruiting
Address
AA MRC LLC Ahmed Arif Medical Research Center
Flint, Michigan,
Status
Active, not recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi,
Status
Completed
Address
Washington University
Saint Louis, Missouri,
Status
Active, not recruiting
Address
Montefiore Medical Center PRIME
Bronx, New York,
Status
Completed
Address
Hospital for Special Surgery
New York, New York,
Status
Completed
Address
SUNY Upstate Medical Center
Syracuse, New York,
Status
Active, not recruiting
Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina,
Status
Active, not recruiting
Address
Medication Management, LLC
Greensboro, North Carolina,
Status
Withdrawn
Address
Shanahan Rheumatology & Immunotherapy, PLLC
Raleigh, North Carolina,
Status
Active, not recruiting
Address
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania,
Status
Active, not recruiting
Address
Innovative Clinical Research, LLC
Greenville, South Carolina,
Status
Active, not recruiting
Address
Metroplex Clinical Research Center, LLC
Dallas, Texas,
Status
Withdrawn
Address
Accurate Clinical Management LLC
Houston, Texas,
Status
Active, not recruiting
Address
Accurate Clinical Research, Inc.
Houston, Texas,
Status
Active, not recruiting
Address
Accurate Clinical Management - Brionez
The Woodlands, Texas,
Status
Active, not recruiting
Address
DM Clinical Research
Tomball, Texas,
Status
Completed
Address
Medical Center Research, LLC
Webster, Texas,
Status
Completed
Address
FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Seattle, Washington,
International Sites
Status
Active, not recruiting
Address
Instituto de Investigaciones Clinicas
Mar del Plata, Buenos Aires,
Status
Active, not recruiting
Address
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires,
Status
Active, not recruiting
Address
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman,
Status
Active, not recruiting
Address
Investigaciones Clinicas Tucuman
San Miguel de Tucuman, Tucuman,
Status
Active, not recruiting
Address
Centro Integral de Reumatologia
San Miguel de Tucumán, Tucuman,
Status
Active, not recruiting
Address
APRILLUS
Ciudad Autonoma Buenos aires, ,
Status
Completed
Address
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires, ,
Status
Active, not recruiting
Address
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, ,
Status
Completed
Address
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, ,
Status
Completed
Address
Hospital General de Agudos Dr. J. M. Ramos Mejia
Ciudad Autonoma Buenos Aires, ,
Status
Active, not recruiting
Address
Sanatorio Allende
Cordoba, ,
Status
Active, not recruiting
Address
Instituto de Reumatologia
Mendoza, ,
Status
Active, not recruiting
Address
Cordis S.A.
Salta, ,
Status
Active, not recruiting
Address
Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan, ,
Status
Active, not recruiting
Address
UMHAT "Pulmed" OOD
Plovdiv, ,
Status
Active, not recruiting
Address
MHAT - Ruse, AD
Ruse, ,
Status
Active, not recruiting
Address
Medizinski Zentar-1-Sevlievo EOOD
Sevlievo, ,
Status
Completed
Address
Medical Center "Excelsior", OOD
Sofia, ,
Status
Active, not recruiting
Address
Medical Center Comac Medical EOOD
Sofia, ,
Status
Active, not recruiting
Address
UMHAT "SofiaMed", OOD
Sofia, ,
Status
Active, not recruiting
Address
UMHAT "Sv. Ivan Rilski", EAD
Sofia, ,
Status
Active, not recruiting
Address
Corporacion de Beneficencia Osorno
Osorno, ,
Status
Active, not recruiting
Address
Centro de Estudios Reumatologicos
Santiago, ,
Status
Active, not recruiting
Address
Centro Medico Prosalud
Santiago, ,
Status
Active, not recruiting
Address
Interin
Santiago, ,
Status
Active, not recruiting
Address
Psicomedica Clinical and Research Group
Santiago, ,
Status
Completed
Address
Quantum Research Santiago
Santiago, ,
Status
Active, not recruiting
Address
Centro de Reumatologia y Ortopedia SAS
Barranquilla, ,
Status
Active, not recruiting
Address
Clínica de la Costa Ltda.
Barranquilla, ,
Status
Active, not recruiting
Address
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, ,
Status
Active, not recruiting
Address
Simedics Ips Sas
Bogotá, ,
Status
Active, not recruiting
Address
Servimed S.A.S.
Bucaramanga, ,
Status
Withdrawn
Address
CIRI - Centrum für Innovative Diagnostik und Therapie GmbH
Frankfurt, Hessen,
Status
Withdrawn
Address
Universitaetsklinikum Koeln
Koeln, Nordrhein Westfalen,
Status
Completed
Address
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, ,
Status
Withdrawn
Address
Asklepios Klinik Altona
Hamburg, ,
Status
Active, not recruiting
Address
Humanitas Research Hospital
Rozzano, Milano,
Status
Active, not recruiting
Address
Ospedale San Raffaele
Milano, ,
Status
Completed
Address
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, ,
Status
Completed
Address
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, ,
Status
Active, not recruiting
Address
Policlinico Universitario Agostino Gemelli
Roma, ,
Status
Not yet recruiting
Address
Ehime University Hospital
Toon-shi, Ehime-Ken,
Status
Recruiting
Address
Tobata General Hospital
Kitakyushu-shi, Fukuoka-Ken,
Status
Recruiting
Address
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka-Ken,
Status
Recruiting
Address
NHO Asahikawa Medical Center
Asahikawa-shi, Hokkaido,
Status
Recruiting
Address
Kanazawa University Hospital
Kanazawa-shi, Ishikawa-Ken,
Status
Recruiting
Address
Kagawa University Hospital
Kita-gun, Kagawa-Ken,
Status
Recruiting
Address
Eiraku Clinic
Kagoshima-shi, Kagoshima-Ken,
Status
Recruiting
Address
Tohoku University Hospital
Sendai-shi, Miyagi-Ken,
Status
Recruiting
Address
Seirei Hamamatsu General Hospital
Hamamatsu-shi, Shizuoka-Ken,
Status
Recruiting
Address
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi-Ken,
Status
Recruiting
Address
St. Luke's International Hospital
Chuo-ku, Tokyo-To,
Status
Not yet recruiting
Address
Tokyo Metropolitan Tama Medical Center
Fuchu-shi, Tokyo-To,
Status
Recruiting
Address
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To,
Status
Recruiting
Address
Keio University Hospital
Shinjuku-ku, Tokyo-To,
Status
Recruiting
Address
Tottori University Hospital
Yonago-shi, Tottori-Ken,
Status
Active, not recruiting
Address
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do,
Status
Completed
Address
Ajou University Hospital
Suwon-si, Gyeonggi-do,
Status
Active, not recruiting
Address
Dong-A University Hospital
Busan, ,
Status
Active, not recruiting
Address
Kyungpook National University Hospital
Daegu, ,
Status
Active, not recruiting
Address
Konkuk University Medical Center
Seoul, ,
Status
Active, not recruiting
Address
Severance Hospital, Yonsei University
Seoul, ,
Status
Completed
Address
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, ,
Status
Active, not recruiting
Address
Hospital Pakar Sultanah Fatimah
Muar, Johor,
Status
Active, not recruiting
Address
Hospital Umum Sarawak
Kuching, Sarawak,
Status
Withdrawn
Address
Sarawak General Hospital
Kuching, Sarawak,
Status
Active, not recruiting
Address
Hospital Selayang
Batu Caves, Selangor,
Status
Active, not recruiting
Address
International Medical University (IMU) Healthcare
Bukit Jalil, Selangor,
Status
Completed
Address
Hospital Kuala Lumpur
Kuala Lumpur, ,
Status
Active, not recruiting
Address
CAP Research
Solferino-Phoenix, ,
Status
Active, not recruiting
Address
Unidad de Investigacion de las Enfermedades Reumaticas
Cuauhtemoc, Distrito Federal,
Status
Active, not recruiting
Address
Clinstile, S.A. de C.V.
Mexico, Distrito Federal,
Status
Active, not recruiting
Address
Clinical Research Institute S.C.
Tlalnepantla, Estado De Mexico,
Status
Active, not recruiting
Address
Morales Vargas Centro de Investigacion, S.C.
Leon, Guanajuato,
Status
Active, not recruiting
Address
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco,
Status
Active, not recruiting
Address
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Guadalajara, Jalisco,
Status
Active, not recruiting
Address
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León,
Status
Active, not recruiting
Address
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi, San Luis Potos,
Status
Active, not recruiting
Address
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua, ,
Status
Active, not recruiting
Address
Hogar Clínica San Juan de Dios - Arequipa
Arequipa, ,
Status
Active, not recruiting
Address
Clinica El Golf
Lima, ,
Status
Active, not recruiting
Address
Clinica Medica Cayetano Heredia
Lima, ,
Status
Active, not recruiting
Address
Clinica San Juan Bautista
Lima, ,
Status
Active, not recruiting
Address
Clinica Vesalio
Lima, ,
Status
Active, not recruiting
Address
GINOBS SA. Instituto de Ginecologia y Reproduccion
Lima, ,
Status
Completed
Address
Hospital Nacional Cayetano Heredia
Lima, ,
Status
Completed
Address
University of Washington Medical Center
Lima, ,
Status
Active, not recruiting
Address
ICCV Research Instituto del Cerebro y la Columna Vertebral
Miraflores, ,
Status
Active, not recruiting
Address
Angeles University Foundation Medical Center
Angeles City, Pampanga, ,
Status
Active, not recruiting
Address
Mary Mediatrix Medical Center
Batangas, ,
Status
Active, not recruiting
Address
De La Salle University Medical Center
Dasmariñas City, Cavite, ,
Status
Active, not recruiting
Address
Davao Doctors Hospital
Davao City, ,
Status
Active, not recruiting
Address
Southern Philippines Medical Center
Davao City, ,
Status
Active, not recruiting
Address
Iloilo Doctors Hospital
Iloilo City, ,
Status
Active, not recruiting
Address
St. Luke's Medical Center
Quezon City, ,
Status
Active, not recruiting
Address
CERMED
Bialystok, ,
Status
Active, not recruiting
Address
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, ,
Status
Active, not recruiting
Address
Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela
Elblag, ,
Status
Active, not recruiting
Address
Centrum Medyczne Plejady
Krakow, ,
Status
Active, not recruiting
Address
Nzoz Atopia
Krakow, ,
Status
Active, not recruiting
Address
Rheuma Medicus Zaklad
Warsawa, ,
Status
Active, not recruiting
Address
Spitalul Clinic "Dr.I. Cantacuzino"
Bucuresti, ,
Status
Active, not recruiting
Address
Spitalul Clinic "Sf. Maria"
Bucuresti, ,
Status
Not yet recruiting
Address
S.C Mediab S.R.L
Tirgu Mures, ,
Status
Recruiting
Address
LLC "Alliance Biomedical - Ural Group"
Izhevsk, ,
Status
Active, not recruiting
Address
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
Krasnoyarsk, ,
Status
Withdrawn
Address
BMI "Kursk Regional Clinical Hospital"
Kursk, ,
Status
Active, not recruiting
Address
HMA - Hospital Maria Auxiliadora
Moscow, ,
Status
Active, not recruiting
Address
LLC Medical Sanitary Unit#157
Saint-Petersburg, ,
Status
Active, not recruiting
Address
SPb SBIH "Clinical Rheumatological Hospital # 25"
Saint-Petersburg, ,
Status
Active, not recruiting
Address
SIH "Saratov City Clinical Hospital # 12"
Saratov, ,
Status
Active, not recruiting
Address
Research Institute of Emergency Medical Care
St. Petersburg, ,
Status
Completed
Address
Wits Clinical Research
Johannesburg, Gauteng,
Status
Active, not recruiting
Address
Netcare Umhlanga Hospital
Durban, KwaZulu-Natal,
Status
Active, not recruiting
Address
Winelands Medical Research Centre
Stellenbosch, Western Cape,
Status
Active, not recruiting
Address
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, ,
Status
Completed
Address
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, ,
Status
Active, not recruiting
Address
Taichung Veterans General Hospital
Taichung, ,
