A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Start Date
5/20/2023
Completion Date
7/28/2027
Summary
The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: * Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater * Have active DM or active PM. * Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. * Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (dazukibart) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about 1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both dazukibart and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if dazukibart is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PF-06823859
Placebo
Conditions
Locations
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona 85306
United States
Neuromuscular Research Center
Phoenix, Arizona 85028
United States
Mayo Clinic Hospital
Phoenix, Arizona 85054
United States
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona 85259
United States
200 UCLA Medical Plaza
Los Angeles, California 90095
United States
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California 90095
United States
UCLA
Los Angeles, California 90095
United States
Center for Clinical Research - Chapman Pavilion
Orange, California 92868
United States
UCI Douglas Hospital
Orange, California 92868
United States
UCI Health Center for Innovative Health Therapies
Orange, California 92868
United States
University of California - Irvine
Orange, California 92868
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States
Lal Bhagchandani, M.D
Margate, Florida 33063
United States
University of Miami
Miami, Florida 33125
United States
University of Miami Dermatology Clinical Trials Unit
Miami, Florida 33136
United States
University of Miami
Miami, Florida 33136
United States
Unviversity of Miami
Miami, Florida 33136
United States
Omega Research Orlando
Orlando, Florida 32808
United States
IRIS Research and Development, LLC
Plantation, Florida 33324
United States
West Broward Pulmonary Consultants
Plantation, Florida 33324
United States
West Broward Rheumatology Associates
Tamarac, Florida 33321
United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas 66205
United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas 66160
United States
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City, Kansas 66160
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
CTC - Brigham & Women's Hospital
Boston, Massachusetts 02115
United States
CTH - Brigham & Women's Hospital
Boston, Massachusetts 02115
United States
Washington University Pulmonary Function Laboratory
St Louis, Missouri 63110
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
New York, New York 10016
United States
NYU Langone Health Clinical Research Center
New York, New York 10016
United States
NYU Langone Health
New York, New York 10016
United States
NYU Langone Radiology
New York, New York 10016
United States
Hospital for Special Surgery - Belaire
New York, New York 10021
United States
Hospital for Special Surgery
New York, New York 10021
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
RAO Research LLC
Oklahoma City, Oklahoma 73116
United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania 15213
United States
UPMC Montefiore Clinical and Translational Research Center (CTRC)
Pittsburgh, Pennsylvania 15213
United States
UPMC Presbyterian Shadyside Hospital
Pittsburgh, Pennsylvania 15213
United States
Arthritis & Rheumatology Research Institute, PLLC
Allen, Texas 75013
United States
Integrative Rheumatology of South Texas
Harlingen, Texas 78550
United States
Nerve & Muscle Center of Texas
Houston, Texas 77030
United States
Biopharma Informatic, LLC
Katy, Texas 77494
United States
Pulmonary and Sleep Center of the Valley
Weslaco, Texas 78596
United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia 25801
United States
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires B2800DGH
Argentina
CER medical Institute
Quilmes, Buenos Aires F.D. B1878
Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province T4000AXL
Argentina
Instituto de Reumatología Medical Center S.A.
Mendoza, 5500
Argentina
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia, Sofia (stolitsa) 1463
Bulgaria
Medical Center Artmed
Plovdiv, 4002
Bulgaria
Anhui Provincial Hospital
Hefei, Anhui 230001
China
China-Japan Friendship Hospital
Beijing, Beijing Municipality 100029
China
Peking Union Medical College Hospital
Beijing, Beijing Municipality 100730
China
Dongguan People's Hospital
Dongguan, Guangdong 523016
China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
China
Cangzhou People's Hospital
Cangzhou, Hebei 061011
China
Xiangya Hospital Central South University
Changsha, Hunan 410008
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210000
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330036
China
Qilu Hospital of Shandong University
Jinan, Shandong 250012
China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality 200001
China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality 200025
China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality 200040
China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality 200127
China
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality 300052
China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310002
China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
China
Dongguan People's Hospital
Dongguan, 523059
China
Hôpital Edouard Herriot
Lyon, 69003
France
Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
Paris, 75013
France
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims, 51092
France
Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
Strasbourg, 67091
France
University of Ulm
Ulm, Baden-Wurttemberg 89081
Germany
Universitaetsklinikum Erlangen
Erlangen, Bavaria 91054
Germany
Ludwig Maximilians University Munich Klinikum
München, 80336
Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya 7632
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Hungary
Medanta-The Medicity
Gurugram (Gurgaon), Haryana 122001
India
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Kochi, Kerala 682040
India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal 700020
India
Rabin Medical Center
Petah Tikva, Central District 4941492
Israel
Sheba Medical Center
Ramat Gan, Central District 5265601
Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB 6423906
Israel
IRCCS Istituto Clinico Humanitas
Rozzano, Milano 20089
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM 00168
Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
Catania, 95121
Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50139
Italy
Irccs Ospedale San Raffaele
Milan, 20132
Italy
Hospital of the university of occupational and environmental health
Kitakyushu-shi, Fukuoka 807-8556
Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa 216-8511
Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574
Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken 700-8557
Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka 586-8521
Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga 520-2192
Japan
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo 113-8519
Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo 113-8603
Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo 160-0023
Japan
Yamaguchi University Hospital
Ube, Yamaguchi 755-8505
Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi 409-3898
Japan
Wakayama Medical University Hospital
Wakayama, 641-8510
Japan
Boca Clinical Trials Mexico S.C.
Guadajalara, Jalisco 44600
Mexico
Centro Integral en Reumatologia
Guadalajara, Jalisco 44160
Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Mexico City 06100
Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City 06700
Mexico
Private Practice - Dr. Miguel Cortes
Cuernavaca, Morelos 62448
Mexico
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, 06700
Mexico
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship 60-324
Poland
Pracownia Radiologiczna WIDOK-MED
Krakow, Lesser Poland Voivodeship 30-147
Poland
Małopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship 30-149
Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship 30-363
Poland
Lux Med
Krakow, Lesser Poland Voivodeship 30-415
Poland
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Lesser Poland Voivodeship 30-901
Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Masovian Voivodeship 02-637
Poland
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
Bialystok, Podlaskie Voivodeship 15-044 Bialystok
Poland
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship 15-077
Poland
Zaklad Diagnostyki Obrazowej HEM s.c.
Bialystok, Podlaskie Voivodeship 15-369
Poland
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship 15-707
Poland
Narodny ustav reumatickych chorob
Piešťany, 921 12
Slovakia
Chonnam National University Bitgoeul Hospital
Gwangju, Kwangju-kwangyokshi 61748
South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do 16499
South Korea
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 02447
South Korea
Hanyang University Seoul Hospital
Seoul, Seoul-teukbyeolsi [seoul] 04763
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de 28031
Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife 38320
Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Karolinska University Hospital Solna
Stockholm, 17164
Sweden
Chi Mei Medical Center
Tainan, Tainan 71004
Taiwan
China Medical University Hospital
Taichung, 404332
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Ankara University Ibni Sina Hospital
Ankara, 06230
Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230
Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520
Turkey (Türkiye)
Queen Elizabeth University Hospital
Glasgow, Glasgow CITY G51 4TF
United Kingdom
Salford Royal Hospital
Salford, Manchester M6 8HD
United Kingdom
Doncaster Royal Infirmary
Doncaster, DN2 5LT
United Kingdom