Actively Recruiting
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Led by Pfizer · Updated on 2026-05-11
318
Participants Needed
66
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
- Receiving a stable dose of standard of care background medications at the time of enrollment
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 66 locations
1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
Actively Recruiting
3
Center for Clinical Research - Chapman Pavilion
Orange, California, United States, 92868
Active, Not Recruiting
4
UCI Douglas Hospital
Orange, California, United States, 92868
Active, Not Recruiting
5
UCI Health Center for Innovative Health Therapies
Orange, California, United States, 92868
Active, Not Recruiting
6
Lal Bhagchandani, M.D
Margate, Florida, United States, 33063
Active, Not Recruiting
7
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
8
West Broward Rheumatology Associates
Tamarac, Florida, United States, 33321
Active, Not Recruiting
9
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
11
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
NYU Langone Health Clinical Research Center
New York, New York, United States, 10016
Actively Recruiting
13
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
14
NYU Langone Radiology
New York, New York, United States, 10016
Actively Recruiting
15
Hospital for Special Surgery
New York, New York, United States, 10021
Not Yet Recruiting
16
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
Actively Recruiting
17
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina, B2800DGH
Not Yet Recruiting
18
CER medical Institute
Quilmes, Buenos Aires F.D., Argentina, B1878
Actively Recruiting
19
Instituto de Reumatología Medical Center S.A.
Mendoza, Argentina, 5500
Actively Recruiting
20
Medical Center Artmed
Plovdiv, Bulgaria, 4002
Actively Recruiting
21
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
22
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
23
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
24
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Actively Recruiting
25
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
26
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
27
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
28
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
29
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
30
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
31
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
32
Hôpital Edouard Herriot
Lyon, France, 69003
Not Yet Recruiting
33
Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
Paris, France, 75013
Not Yet Recruiting
34
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary, 7632
Actively Recruiting
35
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Kochi, Kerala, India, 682040
Actively Recruiting
36
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel, 6423906
Actively Recruiting
37
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
38
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
Catania, Italy, 95121
Actively Recruiting
39
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50139
Actively Recruiting
40
Hospital of the university of occupational and environmental health
Kitakyushu-shi, Fukuoka, Japan, 807-8556
Actively Recruiting
41
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
42
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan, 586-8521
Actively Recruiting
43
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan, 520-2192
Actively Recruiting
44
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
45
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
46
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
47
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Actively Recruiting
48
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
49
Boca Clinical Trials Mexico S.C.
Guadajalara, Jalisco, Mexico, 44600
Not Yet Recruiting
50
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Mexico City, Mexico, 06100
Actively Recruiting
51
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City, Mexico, 06700
Not Yet Recruiting
52
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, Mexico, 06700
Not Yet Recruiting
53
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland, 30-363
Actively Recruiting
54
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Lesser Poland Voivodeship, Poland, 30-901
Actively Recruiting
55
Narodny ustav reumatickych chorob
Piešťany, Slovakia, 921 12
Actively Recruiting
56
Chonnam National University Bitgoeul Hospital
Gwangju, Kwangju-kwangyokshi, South Korea, 61748
Actively Recruiting
57
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea, 16499
Actively Recruiting
58
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
59
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, Spain, 28031
Actively Recruiting
60
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
Actively Recruiting
61
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
62
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
63
Ankara University Ibni Sina Hospital
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
64
Hacettepe Universite Hastaneleri
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
65
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
66
Salford Royal Hospital
Salford, Manchester, United Kingdom, M6 8HD
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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