A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
NCT ID: NCT05895786
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
318 participants
INTERVENTIONAL
2023-05-20
2027-07-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study will be conducted in 2 parallel cohorts: Cohort 1 (DM) and Cohort 2 (PM).
TREATMENT
QUADRUPLE
Study Groups
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PF-06823859
Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
PF-06823859
anti-interferon beta therapy
Placebo
Participants will receive placebo via intravenous infusion every 4 weeks.
Placebo
Placebo for PF-06823859
Interventions
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PF-06823859
anti-interferon beta therapy
Placebo
Placebo for PF-06823859
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale, Arizona, United States
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
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 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
NYU Langone Rusk Pulmonary Function Lab
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
Edinburg, Texas, United States
Integrative Rheumatology of South Texas - Harlingen
Harlingen, Texas, United States
Nerve & Muscle Center of Texas
Houston, 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
Hospital J. M. Ramos Mejía
Buenos Aires, , Argentina
Instituto de Reumatología
Mendoza, , Argentina
UZ Leuven
Leuven, Vlaams-brabant, Belgium
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
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
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
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
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
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
Pracownia Radiologiczna WIDOK-MED
Krakow, Lesser Poland Voivodeship, Poland
Małopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland
Lux Med
Krakow, Lesser Poland Voivodeship, Poland
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Masovian Voivodeship, Poland
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
Bialystok, Podlaskie Voivodeship, Poland
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship, Poland
Zaklad Diagnostyki Obrazowej HEM s.c.
Bialystok, Podlaskie Voivodeship, Poland
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, Poland
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
Chonnam National University Bitgoeul Hospital
Gwangju, Kwangju-kwangyokshi, South Korea
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Karolinska University Hospital Solna
Stockholm, , Sweden
Chi Mei Medical Center
Tainan City, Tainan, Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Ankara University Ibni Sina Hospital
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Queen Elizabeth University Hospital
Glasgow, Glasgow CITY, United Kingdom
Salford Royal Hospital
Salford, Manchester, United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-502739-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C0251006
Identifier Type: -
Identifier Source: org_study_id
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