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)

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.

Study Overview

• Status: Recruiting
• Conditions: Myositis
• Intervention / Treatment: Drug: PF-06823859; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 318
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Mendoza, Argentina, 5500
    • Recruiting
    • Instituto de Reumatología Medical Center S.A.
  • Buenos Aires
    • Zárate, Buenos Aires, Argentina, B2800DGH
      • Not yet recruiting
      • Instituto de Investigaciones Clínicas Zarate
  • Buenos Aires F.D.
    • Quilmes, Buenos Aires F.D., Argentina, B1878
      • Recruiting
      • CER medical Institute
  • Tucumán Province
    • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
      • Recruiting
      • Centro de Investigaciones Médicas Tucumán
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • Medical Center Artmed
  • Sofia (stolitsa)
    • Sofia, Sofia (stolitsa), Bulgaria, 1463
      • Recruiting
      • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
• China
  • Dongguan, China, 523059
    • Recruiting
    • Dongguan People's Hospital
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • Anhui Provincial Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
  • Guangdong
    • Dongguan, Guangdong, China, 523016
      • Recruiting
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
  • Hebei
    • Cangzhou, Hebei, China, 061011
      • Recruiting
      • Cangzhou People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China, 330036
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Recruiting
      • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China, 200001
      • Recruiting
      • Shanghai Jiaotong University School of Medicine, Renji Hospital
    • Shanghai, Shanghai Municipality, China, 200127
      • Recruiting
      • Shanghai Jiaotong University School of Medicine, Renji Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310002
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
• France
  • Lyon, France, 69003
    • Not yet recruiting
    • Hôpital Edouard Herriot
  • Paris, France, 75013
    • Not yet recruiting
    • Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
  • Reims, France, 51092
    • Recruiting
    • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
  • Strasbourg, France, 67091
    • Recruiting
    • Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
• Germany
  • München, Germany, 80336
    • Recruiting
    • Ludwig Maximilians University Munich Klinikum
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Not yet recruiting
      • University of Ulm
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Not yet recruiting
      • Universitaetsklinikum Erlangen
• Hungary
  • Debrecen, Hungary, 4032
    • Recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Recruiting
      • Pecsi Tudomanyegyetem Klinikai Kozpont
• India
  • Haryana
    • Gurugram (Gurgaon), Haryana, India, 122001
      • Recruiting
      • Medanta-The Medicity
  • Kerala
    • Kochi, Kerala, India, 682040
      • Recruiting
      • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
  • West Bengal
    • Kolkata, West Bengal, India, 700020
      • Recruiting
      • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
• Israel
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Recruiting
      • Rabin Medical Center
    • Ramat Gan, Central District, Israel, 5265601
      • Recruiting
      • Sheba Medical Center
  • TELL ABĪB
    • Tel Aviv, TELL ABĪB, Israel, 6423906
      • Recruiting
      • Sourasky Medical Center
• Italy
  • Catania, Italy, 95121
    • Recruiting
    • Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
  • Florence, Italy, 50139
    • Recruiting
    • Azienda Ospedaliera Universitaria Careggi
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • IRCCS Istituto Clinico Humanitas
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Japan
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Wakayama Medical University Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Recruiting
      • Hospital of the University of Occupational and Environmental Health
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • Recruiting
      • St. Marianna University School of Medicine Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8557
      • Recruiting
      • Okayama City General Medical Center Okayama City Hospital
  • Osaka
    • Kawachi-Nagano, Osaka, Japan, 586-8521
      • Recruiting
      • National Hospital Organization Osaka Minami Medical Center
  • Shiga
    • Ōtsu, Shiga, Japan, 520-2192
      • Recruiting
      • Shiga University Of Medical Science Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Recruiting
      • Nippon Medical School Hospital
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Recruiting
      • Institute of Science Tokyo Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Recruiting
      • Tokyo Medical University Hospital
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
      • Recruiting
      • Yamaguchi University Hospital
  • Yamanashi
    • Chuo-shi, Yamanashi, Japan, 409-3898
      • Recruiting
      • University of Yamanashi Hospital
• Mexico
  • Mexico City, Mexico, 06700
    • Not yet recruiting
    • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
  • Jalisco
    • Guadajalara, Jalisco, Mexico, 44600
      • Not yet recruiting
      • Boca Clinical Trials Mexico S.C.
    • Guadalajara, Jalisco, Mexico, 44160
      • Not yet recruiting
      • Centro Integral en Reumatología
  • Mexico City
    • Cuauhtémoc, Mexico City, Mexico, 06100
      • Recruiting
      • Cryptex Investigación Clínica S.A. de C.V.
    • Mexico City, Mexico City, Mexico, 06700
      • Not yet recruiting
      • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62448
      • Recruiting
      • Private Practice - Dr. Miguel Cortes
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-324
      • Recruiting
      • Twoja Przychodnia PCM
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-363
      • Recruiting
      • Centrum Medyczne Plejady
    • Krakow, Lesser Poland Voivodeship, Poland, 30-147
      • Recruiting
      • Pracownia Radiologiczna WIDOK-MED
    • Krakow, Lesser Poland Voivodeship, Poland, 30-149
      • Recruiting
      • Małopolskie Centrum Kliniczne
    • Krakow, Lesser Poland Voivodeship, Poland, 30-415
      • Recruiting
      • Lux Med
    • Krakow, Lesser Poland Voivodeship, Poland, 30-901
      • Recruiting
      • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-637
      • Recruiting
      • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-044 Bialystok
      • Recruiting
      • Centrum Medycyny Oddechowej Robert Mroz spolka jawna
    • Bialystok, Podlaskie Voivodeship, Poland, 15-077
      • Recruiting
      • INTER CLINIC Piotr Adrian Klimiuk
    • Bialystok, Podlaskie Voivodeship, Poland, 15-369
      • Recruiting
      • Zaklad Diagnostyki Obrazowej HEM s.c.
    • Bialystok, Podlaskie Voivodeship, Poland, 15-707
      • Recruiting
      • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
• Slovakia
  • Piešťany, Slovakia, 921 12
    • Recruiting
    • Narodny Ustav Reumatickych Chorob
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Kwangju-kwangyokshi
    • Gwangju, Kwangju-kwangyokshi, South Korea, 61748
      • Recruiting
      • Chonnam National University Bitgoeul Hospital
  • Kyǒnggi-do
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Recruiting
      • Ajou University Hospital
  • Seoul-teukbyeolsi [seoul]
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02447
      • Recruiting
      • Kyung Hee University Hospital
    • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 04763
      • Recruiting
      • Hanyang University Seoul Hospital
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28031
      • Recruiting
      • Hospital Universitario Infanta Leonor
  • Santa CRUZ DE Tenerife
    • San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
      • Recruiting
      • Hospital Universitario de Canarias
• Sweden
  • Stockholm, Sweden, 17164
    • Recruiting
    • Karolinska University Hospital Solna
• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404332
    • Recruiting
    • China Medical University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100225
    • Recruiting
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Medical Foundation-Linkou Branch
  • Tainan
    • Tainan, Tainan, Taiwan, 71004
      • Recruiting
      • Chi Mei Medical Center
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Hacettepe Universite Hastaneleri
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Ankara University Ibni Sina Hospital
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Recruiting
    • Doncaster Royal Infirmary
  • Glasgow CITY
    • Glasgow, Glasgow CITY, United Kingdom, G51 4TF
      • Recruiting
      • Queen Elizabeth University Hospital
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Recruiting
      • Salford Royal Hospital
• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Recruiting
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
    • Phoenix, Arizona, United States, 85028
      • Recruiting
      • Neuromuscular Research Center
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona - Scottsdale
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Clinical & Translational Research Center (CTRC)
    • Los Angeles, California, United States, 90095
      • Recruiting
      • 200 UCLA Medical Plaza
    • Orange, California, United States, 92868
      • Active, not recruiting
      • Center for Clinical Research - Chapman Pavilion
    • Orange, California, United States, 92868
      • Active, not recruiting
      • UCI Douglas Hospital
    • Orange, California, United States, 92868
      • Active, not recruiting
      • UCI Health Center for Innovative Health Therapies
    • Orange, California, United States, 92868
      • Active, not recruiting
      • University of California - Irvine
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
    • Margate, Florida, United States, 33063
      • Active, not recruiting
      • Lal Bhagchandani, M.D
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
    • Miami, Florida, United States, 33125
      • Recruiting
      • University of Miami
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Dermatology Clinical Trials Unit
    • Miami, Florida, United States, 33136
      • Recruiting
      • Unviversity of Miami
    • Orlando, Florida, United States, 32808
      • Active, not recruiting
      • Omega Research Orlando
    • Plantation, Florida, United States, 33324
      • Recruiting
      • IRIS Research and Development, LLC
    • Plantation, Florida, United States, 33324
      • Recruiting
      • West Broward Pulmonary Consultants
    • Tamarac, Florida, United States, 33321
      • Active, not recruiting
      • West Broward Rheumatology Associates
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center - Hoglund Brain Imaging Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • CTH - Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • CTC - Brigham & Women's Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63110
      • Active, not recruiting
      • Washington University Pulmonary Function Laboratory
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
    • New York, New York, United States, 10021
      • Not yet recruiting
      • Hospital for Special Surgery
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health Clinical Research Center
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Radiology
    • New York, New York, United States, 10021
      • Not yet recruiting
      • Hospital for Special Surgery - Belaire
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Recruiting
      • RAO Research LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Arthritis and Autoimmunity Center, Falk Clinic
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Montefiore Clinical and Translational Research Center (CTRC)
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Presbyterian Shadyside Hospital
  • Texas
    • Allen, Texas, United States, 75013
      • Recruiting
      • Arthritis & Rheumatology Research Institute, PLLC
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Integrative Rheumatology of South Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Nerve & Muscle Center of Texas
    • Katy, Texas, United States, 77494
      • Not yet recruiting
      • Biopharma Informatic, LLC
    • Weslaco, Texas, United States, 78596
      • Recruiting
      • Pulmonary and Sleep Center of the Valley
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Recruiting
      • Rheumatology & Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-06823859; Participants will receive PF-06823859 via intravenous infusion every 4 weeks.	Drug: PF-06823859; anti-interferon beta therapy
Placebo Comparator: Placebo; Participants will receive placebo via intravenous infusion every 4 weeks.	Drug: Placebo; Placebo for PF-06823859

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)	Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome	24 weeks outside of the US and 52 weeks in the US
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis	Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA ≥2 will be assessed	24 and 52 weeks in the US only
Corticosteroid (CS) dose assessment	Normalized Area Under the Curve (AUC) of corticosteroid dose	52 weeks
Moderate change in Total Improvement Score	Total Improvement Score 0 to 100 with higher scores indicating a better outcome.	24 weeks in the US and 52 weeks outside of the US
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)	Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome	24 weeks outside of the US and 52 weeks in the US
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome	24 weeks outside of the US and 52 weeks in the US
Response in corticosteroid tapering	At least 50% reduction from baseline or reduction in corticosteroid (CS) dose to <7.5 mg/day at Week 52 for participants with baseline CS dose ≥10 mg/day.	52 weeks US only
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)	Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score ≥14 will be assessed.	Week 24 outside the US
Change from baseline in 5-D Itch Scale Score	5-D Pruritis Scale 5 to 25 with higher scores indicating a worse outcome. Only participants with baseline CDASI-A score ≥14 will be assessed.	24 weeks outside of the US and 52 weeks in the US

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): July 28, 2027
• Study Completion (Estimated): July 28, 2027

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dermatomyositis; Polymyositis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatomyositis; Polymyositis; Myositis
• Other Study ID Numbers: C0251006; 2022-502739-20-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes