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Набира участници Фаза 3 NCT05895786

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Фаза 3 – широко изпитване преди одобрение
Заболявания: Myositis

Спонсор: Pfizer

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, 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 at the time of enrollment. 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 serious infections 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 response to 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 severe neurological 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 of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease * Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors * Other medical or laboratory abnormality that may increase the risk of study participation * Previous administration with an investigational product (drug or vaccine) within 30 days 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 of anti-interferon beta therapy * Prior SOC medication that does not fulfill the criteria * Certain laboratory results from screening assessments that may interfere with study participation. * Investigator site staff directly involved in the conduct of the study and their family members, site staff and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members
Интервенции
PF-06823859
DRUG
Placebo
DRUG
Места на провеждане 147
Argentina (4)
Instituto de Reumatología Medical Center S.A.
Mendoza
CER medical Institute
Quilmes , Buenos Aires F.D.
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman , Tucumán Province
Instituto de Investigaciones Clinicas Zarate
Zárate , Buenos Aires
NOT_YET_RECRUITING
България (2)
Medical Center Artmed
Plovdiv
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia , Sofia (stolitsa)
Китай (22)
China-Japan Friendship Hospital
Beijing , Beijing Municipality
Peking Union Medical College Hospital
Beijing , Beijing Municipality
Cangzhou People's Hospital
Cangzhou , Hebei
Xiangya Hospital Central South University
Changsha , Hunan
West China Hospital, Sichuan University
Chengdu , Sichuan
Dongguan People's Hospital
Dongguan , Guangdong
Dongguan People's Hospital
Dongguan
Guangdong Provincial People's Hospital
Guangzhou , Guangdong
Guangdong Provincial People's Hospital
Guangzhou , Guangdong
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
Anhui Provincial Hospital
Hefei , Anhui
Qilu Hospital of Shandong University
Jinan , Shandong
First Affiliated Hospital of Kunming Medical University
Kunming , Yunnan
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
The Second Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing , Jiangsu
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai , Shanghai Municipality
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai , Shanghai Municipality
Huashan Hospital, Fudan University
Shanghai , Shanghai Municipality
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai , Shanghai Municipality
Tianjin Medical University General Hospital
Tianjin , Tianjin Municipality
Франция (4)
Hôpital Edouard Herriot
Lyon
NOT_YET_RECRUITING
Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
Paris
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims
Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
Strasbourg
Германия (2)
Universitaetsklinikum Erlangen
Erlangen , Bavaria
NOT_YET_RECRUITING
Ludwig Maximilians University Munich Klinikum
München
NOT_YET_RECRUITING
Унгария (2)
Debreceni Egyetem Klinikai Kozpont
Debrecen
Pécsi Tudományegyetem Klinikai Központ
Pécs , Baranya
NOT_YET_RECRUITING
Индия (3)
Medanta-The Medicity
Gurugram (Gurgaon) , Haryana
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Kochi , Kerala
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata , West Bengal
Израел (3)
Rabin Medical Center
Petah Tikva , Central District
Sheba Medical Center
Ramat Gan , Central District
Sourasky Medical Center
Tel Aviv , TELL ABĪB
Италия (5)
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
Catania
Azienda Ospedaliera Universitaria Careggi
Florence
Irccs Ospedale San Raffaele
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma , RM
IRCCS Istituto Clinico Humanitas
Rozzano , Milano
Япония (12)
Institute of Science Tokyo Hospital
Bunkyo-ku , Tokyo
Nippon Medical School Hospital
Bunkyo-ku , Tokyo
University of Yamanashi Hospital
Chuo-shi , Yamanashi
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano , Osaka
St. Marianna University School of Medicine Hospital
Kawasaki , Kanagawa
Hospital of the university of occupational and environmental health
Kitakyushu-shi , Fukuoka
Okayama City General Medical Center Okayama City Hospital
Okayama , Okayama-ken
Shiga University of Medical Science Hospital
Ōtsu , Shiga
Tohoku University Hospital
Sendai , Miyagi
Tokyo Medical University Hospital
Shinjuku-ku , Tokyo
Yamaguchi University Hospital
Ube , Yamaguchi
Wakayama Medical University Hospital
Wakayama
Mexico (6)
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc , Mexico City
Private Practice - Dr. Miguel Cortes
Cuernavaca , Morelos
Boca Clinical Trials Mexico S.C.
Guadajalara , Jalisco
NOT_YET_RECRUITING
Centro Integral en Reumatologia
Guadalajara , Jalisco
NOT_YET_RECRUITING
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City , Mexico City
NOT_YET_RECRUITING
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City
NOT_YET_RECRUITING
Полша (11)
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
Bialystok , Podlaskie Voivodeship
INTER CLINIC Piotr Adrian Klimiuk
Bialystok , Podlaskie Voivodeship
Zaklad Diagnostyki Obrazowej HEM s.c.
Bialystok , Podlaskie Voivodeship
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok , Podlaskie Voivodeship
Pracownia Radiologiczna WIDOK-MED
Krakow , Lesser Poland Voivodeship
Małopolskie Centrum Kliniczne
Krakow , Lesser Poland Voivodeship
Centrum Medyczne Plejady
Krakow , Lesser Poland Voivodeship
Lux Med
Krakow , Lesser Poland Voivodeship
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow , Lesser Poland Voivodeship
Twoja Przychodnia PCM
Poznan , Greater Poland Voivodeship
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw , Masovian Voivodeship
Словакия (1)
Narodny ustav reumatickych chorob
Piešťany
Южна Корея (5)
Chonnam National University Bitgoeul Hospital
Gwangju , Kwangju-kwangyokshi
Kyung Hee University Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Hanyang University Seoul Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Seoul National University Hospital
Seoul
Ajou University Hospital
Suwon , Kyǒnggi-do
Испания (4)
Hospital Universitario Infanta Leonor
Madrid , Madrid, Comunidad de
NOT_YET_RECRUITING
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario de Canarias
San Cristóbal de La Laguna , Santa CRUZ DE Tenerife
Швеция (1)
Karolinska University Hospital Solna
Stockholm
Taiwan (6)
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi Mei Medical Center
Tainan , Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Турция (4)
Ankara University Ibni Sina Hospital
Ankara
NOT_YET_RECRUITING
Hacettepe Universite Hastaneleri
Ankara
Memorial Ankara Hastanesi
Ankara
NOT_YET_RECRUITING
Memorial Ankara Hastanesi
Ankara
Великобритания (3)
Doncaster Royal Infirmary
Doncaster
Queen Elizabeth University Hospital
Glasgow , Glasgow CITY
Salford Royal Hospital
Salford , Manchester
САЩ (47)
Arthritis & Rheumatology Research Institute, PLLC
Allen , Texas
Rheumatology & Pulmonary Clinic
Beckley , West Virginia
Brigham and Women's Hospital
Boston , Massachusetts
CTC - Brigham & Women's Hospital
Boston , Massachusetts
CTH - Brigham & Women's Hospital
Boston , Massachusetts
Cleveland Clinic
Cleveland , Ohio
Integrative Rheumatology of South Texas
Edinburg , Texas
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway , Kansas
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale , Arizona
Integrative Rheumatology of South Texas
Harlingen , Texas
Nerve & Muscle Center of Texas
Houston , Texas
Mayo Clinic in Florida
Jacksonville , Florida
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City , Kansas
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City , Kansas
University of Kansas Medical Center
Kansas City , Kansas
Biopharma Informatic, LLC
Katy , Texas
NOT_YET_RECRUITING
200 UCLA Medical Plaza
Los Angeles , California
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles , California
UCLA
Los Angeles , California
Lal Bhagchandani, M.D
Margate , Florida
ACTIVE_NOT_RECRUITING
University of Miami
Miami , Florida
University of Miami Dermatology Clinical Trials Unit
Miami , Florida
University of Miami
Miami , Florida
Unviversity of Miami
Miami , Florida
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
New York , New York
NYU Langone Health Clinical Research Center
New York , New York
NYU Langone Health
New York , New York
NYU Langone Radiology
New York , New York
Hospital for Special Surgery - Belaire
New York , New York
NOT_YET_RECRUITING
Hospital for Special Surgery
New York , New York
NOT_YET_RECRUITING
Center for Clinical Research - Chapman Pavilion
Orange , California
ACTIVE_NOT_RECRUITING
UCI Douglas Hospital
Orange , California
ACTIVE_NOT_RECRUITING
UCI Health Center for Innovative Health Therapies
Orange , California
ACTIVE_NOT_RECRUITING
University of California - Irvine
Orange , California
ACTIVE_NOT_RECRUITING
Omega Research Orlando
Orlando , Florida
ACTIVE_NOT_RECRUITING
Neuromuscular Research Center
Phoenix , Arizona
Mayo Clinic Hospital
Phoenix , Arizona
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
UPMC Montefiore Clinical and Translational Research Center (CTRC)
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
UPMC Presbyterian Shadyside Hospital
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
IRIS Research and Development, LLC
Plantation , Florida
West Broward Pulmonary Consultants
Plantation , Florida
Mayo Clinic in Arizona - Scottsdale
Scottsdale , Arizona
Washington University Pulmonary Function Laboratory
St Louis , Missouri
ACTIVE_NOT_RECRUITING
Washington University School of Medicine
St Louis , Missouri
ACTIVE_NOT_RECRUITING
West Broward Rheumatology Associates
Tamarac , Florida
ACTIVE_NOT_RECRUITING
Pulmonary and Sleep Center of the Valley
Weslaco , Texas
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
20.05.2023
Крайна дата
28.07.2027
Регистрационен номер
NCT05895786
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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