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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT05895786

Registry updated: 2026-09-15
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Description

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.

Interventions

  • PF-06823859 (Drug)
    anti-interferon beta therapy
  • Placebo (Drug)
    Placebo for PF-06823859

Eligibility criteria

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

Conditions

Myositis

Locations

  • Arizona Arthritis & Rheumatology Research, PLLC — Glendale, Arizona, United States
  • Neuromuscular Research Center — Phoenix, 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
  • Samir Macwan, M.D., Inc. — Rancho Mirage, 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
  • 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
  • Hospital for Special Surgery - Belaire — New York, New York, United States
  • Hospital for Special Surgery — New York, New York, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • RAO Research LLC — Oklahoma City, Oklahoma, United States
  • UPMC Arthritis and Autoimmunity Center, Falk Clinic — Pittsburgh, Pennsylvania, United States
  • UPMC Montefiore Clinical and Translational Research Center (CTRC) — Pittsburgh, Pennsylvania, United States
  • UPMC Presbyterian Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • Integrative Rheumatology of South Texas — Edinburg, Texas, United States
  • Arthritis & Rheumatology Research Institute, PLLC — Frisco, 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
  • CER medical Institute — Quilmes, Buenos Aires F.D., Argentina
  • Alto Dorrego — Villa Nueva, Mendoza Province, Argentina
  • Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman, Tucumán Province, Argentina
  • Instituto de Reumatología Medical Center S.A. — Mendoza, Argentina
  • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD — Sofia, Sofia (stolitsa), Bulgaria
  • Medical Center Artmed — Plovdiv, 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
  • 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
  • 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
  • Hôpital Edouard Herriot — Lyon, France
  • Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires — Paris, France
  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche — Reims, France
  • Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil — Strasbourg, France
  • University of Ulm — Ulm, Baden-Wurttemberg, Germany
  • 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
  • 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
  • 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
  • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V. — Mexico City, Mexico
  • Twoja Przychodnia PCM — Poznan, Greater Poland Voivodeship, Poland
  • Małopolskie Centrum Kliniczne — Krakow, Lesser Poland Voivodeship, Poland
  • Centrum Medyczne Plejady — 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
  • Ajou University Hospital — Suwon, Kyǒnggi-do, South Korea
  • Kyung Hee University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Hanyang University Seoul Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Chonnam National University Hospital — Gwangju, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Hospital Universitario Infanta Leonor — Madrid, Madrid, Comunidad de, Spain
  • 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, 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, Taiwan
  • Ankara University Ibni Sina Hospital — Ankara, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri — 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
  • Doncaster Royal Infirmary — Doncaster, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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