A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
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)
2 other identifiers
interventional
318
20 countries
147
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2023
Typical duration for phase_3
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedStudy Start
First participant enrolled
May 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2027
April 23, 2026
April 1, 2026
4.2 years
April 27, 2023
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moderate change in Total Improvement Score (TIS)
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
24 weeks outside of the United States (US) and 52 weeks in the US
Secondary Outcomes (9)
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
24 weeks outside of the US and 52 weeks in the US
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)
Week 24 outside the US
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis
24 and 52 weeks in the US only
Corticosteroid (CS) dose assessment
52 weeks
Moderate change in Total Improvement Score
24 weeks in the US and 52 weeks outside of the US
- +4 more secondary outcomes
Study Arms (2)
PF-06823859
EXPERIMENTALParticipants will receive PF-06823859 via intravenous infusion every 4 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo via intravenous infusion every 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years old.
- Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.
You may not qualify if:
- Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (147)
Arizona Arthritis & Rheumatology Associates, P.C.
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
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
Edinburg, Texas, 78539, 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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 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
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 District, 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)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The sponsor, participants, and site personnel (including the investigator) will be masked to study treatment and will not know whether active study medication or placebo is being administered to participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
June 9, 2023
Study Start
May 20, 2023
Primary Completion (Estimated)
July 28, 2027
Study Completion (Estimated)
July 28, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.