A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Phase 3 – large-scale trial before approval
Conditions:
Myositis
Sponsor: Pfizer
trial.available_in:
БГ
Overview
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.
Who can participate
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
Interventions
PF-06823859
DRUG
Placebo
DRUG
Locations
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
Bulgaria (2)
Medical Center Artmed
Plovdiv
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia , Sofia (stolitsa)
China (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
France (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
Germany (2)
Universitaetsklinikum Erlangen
Erlangen , Bavaria
NOT_YET_RECRUITING
Ludwig Maximilians University Munich Klinikum
München
NOT_YET_RECRUITING
Hungary (2)
Debreceni Egyetem Klinikai Kozpont
Debrecen
Pécsi Tudományegyetem Klinikai Központ
Pécs , Baranya
NOT_YET_RECRUITING
India (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
Israel (3)
Rabin Medical Center
Petah Tikva , Central District
Sheba Medical Center
Ramat Gan , Central District
Sourasky Medical Center
Tel Aviv , TELL ABĪB
Italy (5)
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania