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RECRUITING

NCT05895786

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2023-05-20

Completion Date

2027-07-28

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Myositis

Interventions

DRUG

PF-06823859

anti-interferon beta therapy

DRUG

Placebo

Placebo for PF-06823859

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

Locations (138)

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

Mayo Clinic in Arizona - Scottsdale

Scottsdale, Arizona, United States

200 UCLA Medical Plaza

Los Angeles, California, United States

UCLA Clinical & Translational Research Center (CTRC)

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

Center for Clinical Research - Chapman Pavilion

Orange, California, United States

UCI Douglas Hospital

Orange, California, United States

UCI Health Center for Innovative Health Therapies

Orange, California, United States

University of California - Irvine

Orange, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Lal Bhagchandani, M.D

Margate, Florida, United States

University of Miami

Miami, Florida, United States

University of Miami Dermatology Clinical Trials Unit

Miami, Florida, United States

University of Miami

Miami, Florida, United States

Unviversity of Miami

Miami, Florida, United States

Omega Research Orlando

Orlando, Florida, United States

IRIS Research and Development, LLC

Plantation, Florida, United States

West Broward Pulmonary Consultants

Plantation, Florida, United States

West Broward Rheumatology Associates

Tamarac, Florida, United States

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)

Fairway, Kansas, United States

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow

Kansas City, Kansas, United States

University of Kansas Medical Center - Hoglund Brain Imaging Center

Kansas City, Kansas, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

CTC - Brigham & Women's Hospital

Boston, Massachusetts, United States

CTH - Brigham & Women's Hospital

Boston, Massachusetts, United States

Washington University Pulmonary Function Laboratory

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy

New York, New York, United States

NYU Langone Health Clinical Research Center

New York, New York, United States

NYU Langone Health

New York, New York, United States

NYU Langone Radiology

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Arthritis & Rheumatology Research Institute, PLLC

Allen, Texas, United States

Integrative Rheumatology of South Texas - Harlingen

Harlingen, Texas, United States

Integrative Rheumatology of South Texas

Harlingen, Texas, United States

Nerve & Muscle Center of Texas

Houston, Texas, United States

Biopharma Informatic, LLC

Katy, Texas, United States

Pulmonary and Sleep Center of the Valley

Weslaco, Texas, United States

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, United States

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

CER medical Institute

Quilmes, Buenos Aires F.D., Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Instituto de Reumatología

Mendoza, Argentina

Medical Center Artmed

Plovdiv, Bulgaria

Diagnostic Consultative Centre (DCC) - Foкus 5

Sofia, Bulgaria

Anhui Provincial Hospital

Hefei, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Cangzhou People's Hospital

Cangzhou, Hebei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Dongguan People's Hospital

Dongguan, China

Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

Reims, France

Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil

Strasbourg, France

Universitaetsklinikum Erlangen

Erlangen, Bavaria, Germany

Ludwig Maximilians University Munich Klinikum

München, Germany

Pécsi Tudományegyetem Klinikai Központ

Pécs, Baranya, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Medanta-The Medicity

Gurugram (Gurgaon), Haryana, India

CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

Kochi, Kerala, India

Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

Kolkata, West Bengal, India

Rabin Medical Center

Petah Tikva, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania

Catania, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Irccs Ospedale San Raffaele

Milan, Italy

Hospital of the university of occupational and environmental health

Kitakyushu-shi, Fukuoka, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Okayama-ken, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

University of Yamanashi Hospital

Chuo-shi, Yamanashi, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Boca Clinical Trials Mexico S.C.

Guadajalara, Jalisco, Mexico

Centro Integral en Reumatologia

Guadalajara, Jalisco, Mexico

Cryptex Investigación Clínica S.A. de C.V.

Cuauhtémoc, Mexico City, Mexico

CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

Mexico City, Mexico City, Mexico

Private Practice - Dr. Miguel Cortes

Cuernavaca, Morelos, Mexico

Twoja Przychodnia PCM

Poznan, Greater Poland Voivodeship, Poland

Pracownia Radiologiczna WIDOK-MED