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NCT05895786PHASE3Recruiting

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

Pfizer

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

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

DRUG

PF-06823859

DRUG

Placebo

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Conditions

Myositis

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