Phase
Condition
Idiopathic Inflammatory Myopathies
Connective Tissue Diseases
Myositis
Treatment
PF-06823859
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female adults (≥18 years old or minimum legal adult age as defined per localregulation, whichever is greater)
Active dermatomyositis (DM) or polymyositis (PM) with age of onset
18 years old.
Must be receiving a stable dose of standard of care (SOC) background medications atthe time of enrollment.
Exclusion
Exclusion Criteria:
Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
Existing diagnosis of inclusion body myositis (IBM)
Presence of immune-mediated necrotizing myositis (IMNM)
Myositis with end-stage organ involvement
Active bacterial, viral or fungal infections or hospitalizations for seriousinfections within 60 days prior to enrollment
History of recurrent bacterial, viral, fungal, mycobacterial or other infections
Clinically significant finding on a chest x-ray
Have cancer or a history of cancer within 5 years of screening
Significant current or prior disease conditions that may interfere with the responseto or safety of the study medicine, including but not limited to:
history of major organ transplant
acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
preexisting demyelinating disorder such as multiple sclerosis, or other severeneurological disorder
major surgery within 4 weeks of screening, or scheduled to occur during the study,excluding diagnostic surgery
previous treatment with total lymphoid irradiation
history of any lymphoproliferative disorder such as Epstein Barr Virus, history oflymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
Clinically significant depression, suicidal ideation, or previous history ofsuicidal behaviors
Other medical or laboratory abnormality that may increase the risk of studyparticipation
Previous administration with an investigational product (drug or vaccine) within 30days or of the first dose of study medicine
Current use or incomplete appropriate washout period of any prohibited medication(s)or known exposure to anti-interferon beta (PF-06823859) or any type ofanti-interferon beta therapy
Prior SOC medication that does not fulfill the criteria
Certain laboratory results from screening assessments that may interfere with studyparticipation.
Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff and sponsor and sponsor delegate employees directlyinvolved in the conduct of the study and their family members
Study Design
Connect with a study center
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires B2800DGH
ArgentinaSite Not Available
CER medical Institute
Quilmes, Ciudad Autónoma DE Buenos Aires B1878
ArgentinaActive - Recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. DE Tucuman, Tucumán T4000AXL
ArgentinaActive - Recruiting
Hospital J. M. Ramos Mejía
Ciudad Autónoma de Buenos Aires, C1221ADC
ArgentinaSite Not Available
Instituto de Reumatología
Mendoza, 5500
ArgentinaSite Not Available
UZ Leuven
Leuven, Vlaams-brabant 3000
BelgiumSite Not Available
Hopital Erasme
Brussels, 1070
BelgiumSite Not Available
Medical Center Artmed
Plovdiv, 4000
BulgariaActive - Recruiting
Diagnostic Consultative Centre (DCC) - Foкus 5
Sofia, 1612
BulgariaSite Not Available
Anhui Provincial Hospital
Hefei, Anhui 230001
ChinaActive - Recruiting
China-Japan Friendship Hospital
Beijing, Beijing 100029
ChinaActive - Recruiting
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Cangzhou People's Hospital
Cangzhou, Hebei 061011
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha, Hunan 410008
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong 250012
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200025
ChinaActive - Recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai 200127
ChinaActive - Recruiting
West China Hospital, Sichuan University
Cheng Du, Sichuan 610041
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan Sheng 650032
ChinaActive - Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims, 51092
FranceSite Not Available
Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
Strasbourg, 67091
FranceActive - Recruiting
Universitaetsklinikum Erlangen
Erlangen, Bayern 91054
GermanySite Not Available
Ludwig Maximilians University Munich Klinikum
Munchen, 80336
GermanySite Not Available
Budai Irgalmasrendi Korhaz
Budapest, 1027
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungaryActive - Recruiting
Institute of Neurosciences
Surat, Gujarat 395001
IndiaActive - Recruiting
Medanta-The Medicity
Gurugram (Gurgaon), Haryana 122001
IndiaSite Not Available
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Cochin, Kerala 682040
IndiaActive - Recruiting
Dr. Shenoy's Care
Cochin, Kerala 682040
IndiaActive - Recruiting
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata, WEST Bengal 700020
IndiaActive - Recruiting
Rabin Medical Center
Petah Tikva, Hamerkaz 4941492
IsraelActive - Recruiting
Sheba Medical Center
Ramat Gan, Hamerkaz 5265601
IsraelActive - Recruiting
Sourasky Medical Center
Tel Aviv, Tell Abīb 6423906
IsraelActive - Recruiting
Fondazione Policlinico Tor Vergata
Rome, Lazio 00133
ItalyActive - Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Milano 20089
ItalyActive - Recruiting
Istituto Clinico Humanitas
Rozzano, Milano 20089
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM 00168
ItalyActive - Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
Catania, 95121
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Careggi
Firenze, 50139
ItalyActive - Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
ItalySite Not Available
Irccs Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Hospital of the university of occupational and environmental health
Kitakyushu-shi, Fukuoka 807-8556
JapanActive - Recruiting
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido 0700901
JapanSite Not Available
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanSite Not Available
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa 216-8511
JapanActive - Recruiting
Tohoku University Hospital
Sendai, Miyagi 980-8574
JapanActive - Recruiting
Tohoku University Hospital
Sendai-shi, Miyagi 980-8574
JapanSite Not Available
Okayama City General Medical Center Okayama City Hospital
Okayama-shi, Okayama 700-8557
JapanActive - Recruiting
National Hospital Organization Osaka Minami Medical Center
Kawachinagano, Osaka 586-8521
JapanActive - Recruiting
Shiga University of Medical Science Hospital
Otsu, Shiga 520-2192
JapanActive - Recruiting
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo 113-8603
JapanActive - Recruiting
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo 113-8519
JapanActive - Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo 160-0023
JapanActive - Recruiting
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanSite Not Available
Chonnam National University Bitgoeul Hospital
Gwangju, Kwangju-kwangyokshi 61748
Korea, Republic ofActive - Recruiting
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 02447
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Distrito Federal 06100
MexicoActive - Recruiting
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad De México, Distrito Federal 06100
MexicoSite Not Available
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Distrito Federal 06700
MexicoSite Not Available
Centro Integral en Reumatologia
Guadalajara, Jalisco 44160
MexicoSite Not Available
Consultorio Privado Dr. Miguel Cortes Hernández
Cuernavaca, Morelos C.P. 62290
MexicoSite Not Available
Private Practice - Dr. Miguel Cortes
Cuernavaca, Morelos 62448
MexicoActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Mazowieckie 02-637
PolandActive - Recruiting
Centrum Medyczne Plejady
Krakow, Małopolskie 30-363
PolandActive - Recruiting
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Kraków, Małopolskie 30-901
PolandActive - Recruiting
Lux Med
Kraków, Małopolskie 30-415
PolandActive - Recruiting
Małopolskie Centrum Kliniczne
Kraków, Małopolskie 30-149
PolandActive - Recruiting
Pracownia Radiologiczna WIDOK-MED
Kraków, Małopolskie 30-147
PolandActive - Recruiting
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
Bialystok, Podlaskie 15-044 Bialystok
PolandActive - Recruiting
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie 15-707
PolandActive - Recruiting
Nova Reuma Społka Partnerska
Bialystok, Podlaskie 15-707
PolandActive - Recruiting
INTER CLINIC Piotr Adrian Klimiuk
Białystok, Podlaskie 15-077
PolandActive - Recruiting
Zaklad Diagnostyki Obrazowej HEM s.c.
Białystok, Podlaskie 15-369
PolandActive - Recruiting
Narodny ustav reumatickych chorob
Piešťany, 921 12
SlovakiaActive - Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña] 15006
SpainSite Not Available
Hospital Universitario QuironSalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario de Canarias
La Laguna, Santa CRUZ DE Tenerife 38320
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Karolinska University Hospital Solna
Stockholm, 17164
SwedenSite Not Available
Chi Mei Medical Center
Tainan City, Tainan 71004
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 404332
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 407
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
TaiwanActive - Recruiting
Ankara University Ibni Sina Hospital
Ankara, 06230
TurkeySite Not Available
Hacettepe Universite Hastaneleri
Ankara, 06230
TurkeyActive - Recruiting
Memorial Ankara Hastanesi
Ankara, 06520
TurkeySite Not Available
Queen Elizabeth University Hospital
Glasgow, Glasgow CITY G51 4TF
United KingdomSite Not Available
Salford Royal Hospital
Salford, Manchester M6 8HD
United KingdomSite Not Available
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona 85306
United StatesActive - Recruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates- Glendale
Glendale, Arizona 85306
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona 85306
United StatesActive - Recruiting
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona 85306
United StatesActive - Recruiting
Mayo Clinic Hospital
Phoenix, Arizona 85054
United StatesActive - Recruiting
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona 85259
United StatesActive - Recruiting
200 UCLA Medical Plaza
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California 90095
United StatesActive - Recruiting
Center for Clinical Research - Chapman Pavilion
Orange, California 92868
United StatesSite Not Available
UCI Douglas Hospital
Orange, California 92868
United StatesSite Not Available
UCI Health Center for Innovative Health Therapies
Orange, California 92868
United StatesSite Not Available
University of California - Irvine
Orange, California 92868
United StatesSite Not Available
Inland Rheumatology & Osteoporosis Medical Group
Upland, California 91786
United StatesSite Not Available
University of Miami
Coral Gables, Florida 33136
United StatesActive - Recruiting
Mayo Clinic in Florida
Jacksonville, Florida 32224
United StatesActive - Recruiting
Lal Bhagchandani, M.D
Margate, Florida 33063
United StatesSite Not Available
University of Miami
Miami, Florida 33125
United StatesActive - Recruiting
University of Miami Dermatology Clinical Trials Unit
Miami, Florida 33125
United StatesActive - Recruiting
Omega Research Orlando
Orlando, Florida 32808
United StatesSite Not Available
IRIS Research and Development, LLC
Plantation, Florida 33324
United StatesSite Not Available
West Broward Pulmonary Consultants
Plantation, Florida 33324
United StatesSite Not Available
West Broward Rheumatology Associates
Tamarac, Florida 33321
United StatesSite Not Available
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas 66205
United StatesActive - Recruiting
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
CTH - Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Washington University Pulmonary Function Laboratory
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York 11201
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Health Clinical Research Center
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Rad1ology
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Radiology
New York, New York 10016
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Arthritis & Rheumatology Research Institute
Allen, Texas 75013
United StatesActive - Recruiting
Arthritis and Rheumatology Research Institute
Allen, Texas 75013
United StatesActive - Recruiting
Integrative Rheumatology of South Texas
Edinburg, Texas 78539
United StatesActive - Recruiting
Integrative Rheumatology of South Texas - Harlingen
Harlingen, Texas 78550
United StatesActive - Recruiting
DLCO
Houston, Texas 77030
United StatesActive - Recruiting
Nerve & Muscle Center of Texas
Houston, Texas 77030
United StatesActive - Recruiting
Pulmonary and Sleep Center of the Valley
Weslaco, Texas 78596
United StatesActive - Recruiting
Rheumatology & Pulmonary Clinic
Beckley, West Virginia 25801
United StatesActive - Recruiting
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