Actively Recruiting
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Effects of PF-06823859 in Adults With Active Idiopathic Inflammatory Myopathies (Dermatomyositis and Polymyositis)
Led by Pfizer · Updated on 2026-06-01
318
Participants Needed
146
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how the study medicine PF-06823859 (dazukibart) works in adults with idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM). These conditions cause muscle inflammation leading to weakness and may include a skin rash in DM. The study aims to assess the safety and effects of dazukibart compared to a placebo in people receiving stable doses of corticosteroids or immunosuppressants. Participants will receive either the study medicine or a placebo through an intravenous infusion lasting about one hour. These infusions occur every four weeks from Day 1 through Week 48 at the study site. The study is randomized and double-blind, meaning neither participants nor researchers know who gets the medicine or placebo during the trial. Participants will be involved for about 13 months, attending 15 visits at the study site. During these visits, muscle strength, skin condition, physical function, fatigue, itch, and corticosteroid use are assessed. The main measurement is the Total Improvement Score at 24 or 52 weeks depending on location. Safety and other symptom measures will be monitored throughout the study period.
CONDITIONS
Brief 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 or older or minimum legal adult age as defined per local regulation
- Active dermatomyositis (DM) or polymyositis (PM) with age of onset 18 years or older
- Must be receiving a stable dose of standard of care background medications (one corticosteroid and/or one immunosuppressant) at enrollment
You will not qualify if you...
- Myositis due to non-idiopathic inflammatory myopathies
- 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 hospitalization for serious infections within 60 days prior to enrollment
- History of recurrent infections including bacterial, viral, fungal, or mycobacterial
- Clinically significant chest x-ray findings
- Current or history of cancer within 5 years of screening
- History of major organ transplant
- Acute coronary syndrome or significant cerebrovascular disease within 24 weeks of screening
- Preexisting demyelinating or severe neurological disorders
- Major surgery within 4 weeks of screening or scheduled during the study (excluding diagnostic surgery)
- Previous treatment with total lymphoid irradiation
- History of lymphoproliferative disorders such as Epstein Barr Virus, lymphoma, or leukemia
- Clinically significant depression or history of suicidal behavior
- Other medical or laboratory abnormalities increasing risk of study participation
- Previous investigational product use within 30 days prior to first study dose
- Current use or incomplete washout of prohibited medications or exposure to anti-interferon beta therapies
- Prior standard of care medication not meeting criteria
- Certain abnormal laboratory results at screening
- Investigator site staff, their family members, sponsor employees, and their families involved in the study conduct are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 to 52 weeks depending on location
Participants receive the study medicine PF-06823859 or placebo via intravenous infusion every 4 weeks.
Infusions every 4 weeks during treatment period
Trial Site Locations
Total: 146 locations
1
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States, 85306
Actively Recruiting
2
Neuromuscular Research Center
Phoenix, Arizona, United States, 85028
Actively Recruiting
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States, 85259
Actively Recruiting
5
200 UCLA Medical Plaza
Los Angeles, California, United States, 90095
Actively Recruiting
6
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
Actively Recruiting
7
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
8
Center for Clinical Research - Chapman Pavilion
Orange, California, United States, 92868
Active, Not Recruiting
9
UCI Douglas Hospital
Orange, California, United States, 92868
Active, Not Recruiting
10
UCI Health Center for Innovative Health Therapies
Orange, California, United States, 92868
Active, Not Recruiting
11
University of California - Irvine
Orange, California, United States, 92868
Active, Not Recruiting
12
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
13
Lal Bhagchandani, M.D
Margate, Florida, United States, 33063
Active, Not Recruiting
14
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
15
University of Miami Dermatology Clinical Trials Unit
Miami, Florida, United States, 33136
Actively Recruiting
16
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
17
Unviversity of Miami
Miami, Florida, United States, 33136
Actively Recruiting
18
Omega Research Orlando
Orlando, Florida, United States, 32808
Active, Not Recruiting
19
IRIS Research and Development, LLC
Plantation, Florida, United States, 33324
Actively Recruiting
20
West Broward Pulmonary Consultants
Plantation, Florida, United States, 33324
Actively Recruiting
21
West Broward Rheumatology Associates
Tamarac, Florida, United States, 33321
Active, Not Recruiting
22
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, United States, 66205
Actively Recruiting
23
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas, United States, 66160
Actively Recruiting
24
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
25
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
26
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
27
CTC - Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
28
CTH - Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
29
Washington University Pulmonary Function Laboratory
St Louis, Missouri, United States, 63110
Active, Not Recruiting
30
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Active, Not Recruiting
31
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
New York, New York, United States, 10016
Actively Recruiting
32
NYU Langone Health Clinical Research Center
New York, New York, United States, 10016
Actively Recruiting
33
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
34
NYU Langone Radiology
New York, New York, United States, 10016
Actively Recruiting
35
Hospital for Special Surgery - Belaire
New York, New York, United States, 10021
Not Yet Recruiting
36
Hospital for Special Surgery
New York, New York, United States, 10021
Not Yet Recruiting
37
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
38
RAO Research LLC
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
39
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
40
UPMC Montefiore Clinical and Translational Research Center (CTRC)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
41
UPMC Presbyterian Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
42
Arthritis & Rheumatology Research Institute, PLLC
Allen, Texas, United States, 75013
Actively Recruiting
43
Integrative Rheumatology of South Texas
Harlingen, Texas, United States, 78550
Actively Recruiting
44
Nerve & Muscle Center of Texas
Houston, Texas, United States, 77030
Actively Recruiting
45
Biopharma Informatic, LLC
Katy, Texas, United States, 77494
Not Yet Recruiting
46
Pulmonary and Sleep Center of the Valley
Weslaco, Texas, United States, 78596
Actively Recruiting
47
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, United States, 25801
Actively Recruiting
48
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina, B2800DGH
Not Yet Recruiting
49
CER medical Institute
Quilmes, Buenos Aires F.D., Argentina, B1878
Actively Recruiting
50
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
51
Instituto de Reumatología Medical Center S.A.
Mendoza, Argentina, 5500
Actively Recruiting
52
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia, Sofia (stolitsa), Bulgaria, 1463
Actively Recruiting
53
Medical Center Artmed
Plovdiv, Bulgaria, 4002
Actively Recruiting
54
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
55
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
56
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
57
Dongguan People's Hospital
Dongguan, Guangdong, China, 523016
Actively Recruiting
58
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
59
Cangzhou People's Hospital
Cangzhou, Hebei, China, 061011
Actively Recruiting
60
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
61
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000
Actively Recruiting
62
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
63
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330036
Actively Recruiting
64
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
65
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
66
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
67
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
68
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
69
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
70
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052
Actively Recruiting
71
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
72
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
73
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
74
Dongguan People's Hospital
Dongguan, China, 523059
Actively Recruiting
75
Hôpital Edouard Herriot
Lyon, France, 69003
Not Yet Recruiting
76
Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
Paris, France, 75013
Not Yet Recruiting
77
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
Reims, France, 51092
Actively Recruiting
78
Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
Strasbourg, France, 67091
Actively Recruiting
79
University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Not Yet Recruiting
80
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Not Yet Recruiting
81
Ludwig Maximilians University Munich Klinikum
München, Germany, 80336
Actively Recruiting
82
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary, 7632
Actively Recruiting
83
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
84
Medanta-The Medicity
Gurugram (Gurgaon), Haryana, India, 122001
Actively Recruiting
85
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
Kochi, Kerala, India, 682040
Actively Recruiting
86
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal, India, 700020
Actively Recruiting
87
Rabin Medical Center
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
88
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
89
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel, 6423906
Actively Recruiting
90
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
91
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, Italy, 00168
Actively Recruiting
92
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
Catania, Italy, 95121
Actively Recruiting
93
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50139
Actively Recruiting
94
Irccs Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
95
Hospital of the university of occupational and environmental health
Kitakyushu-shi, Fukuoka, Japan, 807-8556
Actively Recruiting
96
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Actively Recruiting
97
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
98
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, Japan, 700-8557
Actively Recruiting
99
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan, 586-8521
Actively Recruiting
100
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan, 520-2192
Actively Recruiting
101
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
102
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
103
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
104
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Actively Recruiting
105
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan, 409-3898
Actively Recruiting
106
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
107
Boca Clinical Trials Mexico S.C.
Guadajalara, Jalisco, Mexico, 44600
Not Yet Recruiting
108
Centro Integral en Reumatologia
Guadalajara, Jalisco, Mexico, 44160
Not Yet Recruiting
109
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Mexico City, Mexico, 06100
Actively Recruiting
110
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City, Mexico, 06700
Not Yet Recruiting
111
Private Practice - Dr. Miguel Cortes
Cuernavaca, Morelos, Mexico, 62448
Actively Recruiting
112
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
Mexico City, Mexico, 06700
Not Yet Recruiting
113
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, Poland, 60-324
Actively Recruiting
114
Pracownia Radiologiczna WIDOK-MED
Krakow, Lesser Poland Voivodeship, Poland, 30-147
Actively Recruiting
115
Małopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, Poland, 30-149
Actively Recruiting
116
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland, 30-363
Actively Recruiting
117
Lux Med
Krakow, Lesser Poland Voivodeship, Poland, 30-415
Actively Recruiting
118
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Lesser Poland Voivodeship, Poland, 30-901
Actively Recruiting
119
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
120
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
Bialystok, Podlaskie Voivodeship, Poland, 15-044 Bialystok
Actively Recruiting
121
INTER CLINIC Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship, Poland, 15-077
Actively Recruiting
122
Zaklad Diagnostyki Obrazowej HEM s.c.
Bialystok, Podlaskie Voivodeship, Poland, 15-369
Actively Recruiting
123
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, Poland, 15-707
Actively Recruiting
124
Narodny ustav reumatickych chorob
Piešťany, Slovakia, 921 12
Actively Recruiting
125
Chonnam National University Bitgoeul Hospital
Gwangju, Kwangju-kwangyokshi, South Korea, 61748
Actively Recruiting
126
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea, 16499
Actively Recruiting
127
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02447
Actively Recruiting
128
Hanyang University Seoul Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 04763
Actively Recruiting
129
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
130
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, Spain, 28031
Actively Recruiting
131
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
Actively Recruiting
132
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
133
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
134
Karolinska University Hospital Solna
Stockholm, Sweden, 17164
Actively Recruiting
135
Chi Mei Medical Center
Tainan, Tainan, Taiwan, 71004
Actively Recruiting
136
China Medical University Hospital
Taichung, Taiwan, 404332
Actively Recruiting
137
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
138
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
139
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
140
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
141
Ankara University Ibni Sina Hospital
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
142
Hacettepe Universite Hastaneleri
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
143
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
144
Queen Elizabeth University Hospital
Glasgow, Glasgow CITY, United Kingdom, G51 4TF
Actively Recruiting
145
Salford Royal Hospital
Salford, Manchester, United Kingdom, M6 8HD
Actively Recruiting
146
Doncaster Royal Infirmary
Doncaster, United Kingdom, DN2 5LT
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
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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