New drug hopes to ease rare muscle diseases

NCT ID NCT05895786

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This Phase 3 trial tests a drug called dazukibart in people with active dermatomyositis or polymyositis, rare diseases that cause muscle weakness and inflammation. About 318 adults will receive either the drug or a placebo by IV every 4 weeks for 48 weeks. The study aims to see if dazukibart can improve muscle strength and reduce symptoms compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: dazukibart (PF-06823859)
What this could lead to: If successful, dazukibart could offer a new treatment option to reduce muscle weakness and inflammation in people with dermatomyositis or polymyositis.
What could go wrong: This is a Phase 3 trial, but it is still testing safety and effectiveness. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dermatomyositis juvenile dermatomyositis myositis disease polymyositis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

127 sites in 20 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

200 UCLA Medical Plaza
RECRUITING

Los Angeles, California, 90095, United States
Ajou University Hospital
RECRUITING

Suwon, Kyǒnggi-do, 16499, South Korea
Alto Dorrego
RECRUITING

Villa Nueva, Mendoza Province, 5513, Argentina
Anhui Provincial Hospital
RECRUITING

Hefei, Anhui, 230001, China
Ankara University Ibni Sina Hospital
RECRUITING

Ankara, 06230, Turkey (Türkiye)
Arizona Arthritis & Rheumatology Research, PLLC
RECRUITING

Glendale, Arizona, 85306, United States
Arthritis & Rheumatology Research Institute, PLLC
RECRUITING

Frisco, Texas, 75035, United States
Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania
RECRUITING

Catania, 95121, Italy
Biopharma Informatic, LLC
RECRUITING

Katy, Texas, 77494, United States
Boca Clinical Trials Mexico S.C.
RECRUITING

Guadajalara, Jalisco, 44600, Mexico
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CER medical Institute
RECRUITING

Quilmes, Buenos Aires F.D., B1878, Argentina
CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)
RECRUITING

Kochi, Kerala, 682040, India
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.
RECRUITING

Mexico City, 06700, Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
RECRUITING

Mexico City, Mexico City, 06700, Mexico
CTC - Brigham & Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CTH - Brigham & Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Cangzhou People's Hospital
TERMINATED

Cangzhou, Hebei, 061011, China
Center for Clinical Research - Chapman Pavilion
ACTIVE_NOT_RECRUITING

Orange, California, 92868, United States
Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
RECRUITING

Reims, 51092, France
Centro Integral en Reumatologia
RECRUITING

Guadalajara, Jalisco, 44160, Mexico
Centro de Investigaciones Médicas Tucuman
RECRUITING

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Centrum Medycyny Oddechowej Robert Mroz spolka jawna
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-044 Bialystok, Poland
Centrum Medyczne Plejady
RECRUITING

Krakow, Lesser Poland Voivodeship, 30-363, Poland
Chang Gung Medical Foundation-Linkou Branch
RECRUITING

Taoyuan, 333, Taiwan
Chi Mei Medical Center
RECRUITING

Tainan, Tainan, 71004, Taiwan
China Medical University Hospital
RECRUITING

Taichung, 404332, Taiwan
China-Japan Friendship Hospital
RECRUITING

Beijing, Beijing Municipality, 100029, China
Chonnam National University Hospital
RECRUITING

Gwangju, 61469, South Korea
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Cryptex Investigación Clínica S.A. de C.V.
RECRUITING

Cuauhtémoc, Mexico City, 06100, Mexico
Debreceni Egyetem Klinikai Kozpont
RECRUITING

Debrecen, 4032, Hungary
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
RECRUITING

Sofia, Sofia (stolitsa), 1463, Bulgaria
Doncaster Royal Infirmary
RECRUITING

Doncaster, DN2 5LT, United Kingdom
Dongguan People's Hospital
RECRUITING

Dongguan, Guangdong, 523016, China
Dongguan People's Hospital
RECRUITING

Dongguan, 523059, China
First Affiliated Hospital of Kunming Medical University
RECRUITING

Kunming, Yunnan, 650032, China
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Roma, RM, 00168, Italy
Guangdong Provincial People's Hospital
RECRUITING

Guangzhou, Guangdong, 510080, China
Hacettepe Universite Hastaneleri
RECRUITING

Ankara, 06230, Turkey (Türkiye)
Hanyang University Seoul Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [seoul], 04763, South Korea
Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
RECRUITING

Strasbourg, 67091, France
Hospital General Universitario Gregorio Marañon
RECRUITING

Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Infanta Leonor
RECRUITING

Madrid, Madrid, Comunidad de, 28031, Spain
Hospital Universitario de Canarias
RECRUITING

San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320, Spain
Hospital for Special Surgery
NOT_YET_RECRUITING

New York, New York, 10021, United States
Hospital for Special Surgery - Belaire
NOT_YET_RECRUITING

New York, New York, 10021, United States
Hospital of the university of occupational and environmental health
RECRUITING

Kitakyushu-shi, Fukuoka, 807-8556, Japan
Huashan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200040, China
Hôpital Edouard Herriot
RECRUITING

Lyon, 69003, France
Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires
RECRUITING

Paris, 75013, France
INTER CLINIC Piotr Adrian Klimiuk
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-077, Poland
IRCCS Istituto Clinico Humanitas
RECRUITING

Rozzano, Milano, 20089, Italy
IRIS Research and Development, LLC
RECRUITING

Plantation, Florida, 33324, United States
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
RECRUITING

Kolkata, West Bengal, 700020, India
Institute of Science Tokyo Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8519, Japan
Instituto de Reumatología Medical Center S.A.
RECRUITING

Mendoza, 5500, Argentina
Integrative Rheumatology of South Texas
RECRUITING

Edinburg, Texas, 78539, United States
Integrative Rheumatology of South Texas
RECRUITING

Harlingen, Texas, 78550, United States
Irccs Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy
Karolinska University Hospital Solna
RECRUITING

Stockholm, 17164, Sweden
Kyung Hee University Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [seoul], 02447, South Korea
Lal Bhagchandani, M.D
ACTIVE_NOT_RECRUITING

Margate, Florida, 33063, United States
Ludwig Maximilians University Munich Klinikum
RECRUITING

München, 80336, Germany
Mayo Clinic Hospital
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic in Arizona - Scottsdale
RECRUITING

Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
RECRUITING

Jacksonville, Florida, 32224, United States
Małopolskie Centrum Kliniczne
RECRUITING

Krakow, Lesser Poland Voivodeship, 30-149, Poland
Medanta-The Medicity
RECRUITING

Gurugram (Gurgaon), Haryana, 122001, India
Medical Center Artmed
RECRUITING

Plovdiv, 4002, Bulgaria
Memorial Ankara Hastanesi
RECRUITING

Ankara, 06520, Turkey (Türkiye)
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
RECRUITING

New York, New York, 10016, United States
NYU Langone Health Clinical Research Center
RECRUITING

New York, New York, 10016, United States
NYU Langone Radiology
RECRUITING

New York, New York, 10016, United States
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING

Nanjing, Jiangsu, 210000, China
Narodny ustav reumatickych chorob
RECRUITING

Piešťany, 921 12, Slovakia
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
RECRUITING

Warsaw, Masovian Voivodeship, 02-637, Poland
National Taiwan University Hospital
RECRUITING

Taipei, 100225, Taiwan
Nerve & Muscle Center of Texas
RECRUITING

Houston, Texas, 77030, United States
Neuromuscular Research Center
RECRUITING

Phoenix, Arizona, 85028, United States
Nippon Medical School Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8603, Japan
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-707, Poland
Okayama City General Medical Center Okayama City Hospital
RECRUITING

Okayama, Okayama-ken, 700-8557, Japan
Omega Research Orlando
ACTIVE_NOT_RECRUITING

Orlando, Florida, 32808, United States
Peking Union Medical College Hospital
RECRUITING

Beijing, Beijing Municipality, 100730, China
Private Practice - Dr. Miguel Cortes
RECRUITING

Cuernavaca, Morelos, 62448, Mexico
Pulmonary and Sleep Center of the Valley
RECRUITING

Weslaco, Texas, 78596, United States
Pécsi Tudományegyetem Klinikai Központ
RECRUITING

Pécs, Baranya, 7632, Hungary
Queen Elizabeth University Hospital
RECRUITING

Glasgow, Glasgow CITY, G51 4TF, United Kingdom
RAO Research LLC
RECRUITING

Oklahoma City, Oklahoma, 73116, United States
Rabin Medical Center
RECRUITING

Petah Tikva, Central District, 4941492, Israel
Rheumatology & Pulmonary Clinic
ACTIVE_NOT_RECRUITING

Beckley, West Virginia, 25801, United States
Ruijin Hospital Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, Shanghai Municipality, 200025, China
Salford Royal Hospital
RECRUITING

Salford, Manchester, M6 8HD, United Kingdom
Samir Macwan, M.D., Inc.
RECRUITING

Rancho Mirage, California, 92270, United States
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Shanghai Jiaotong University School of Medicine, Renji Hospital
RECRUITING

Shanghai, Shanghai Municipality, 200001, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
RECRUITING

Shanghai, Shanghai Municipality, 200127, China
Sheba Medical Center
RECRUITING

Ramat Gan, Central District, 5265601, Israel
Shiga University of Medical Science Hospital
RECRUITING

Ōtsu, Shiga, 520-2192, Japan
Sourasky Medical Center
RECRUITING

Tel Aviv, TELL ABĪB, 6423906, Israel
St. Marianna University School of Medicine Hospital
RECRUITING

Kawasaki, Kanagawa, 216-8511, Japan
Taichung Veterans General Hospital
RECRUITING

Taichung, 40705, Taiwan
Taipei Veterans General Hospital
RECRUITING

Taipei, 11217, Taiwan
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jiangxi, 330036, China
The first Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, 310002, China
The first Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, 310003, China
Tianjin Medical University General Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300052, China
Tohoku University Hospital
RECRUITING

Sendai, Miyagi, 980-8574, Japan
Tokyo Medical University Hospital
RECRUITING

Shinjuku-ku, Tokyo, 160-0023, Japan
Twoja Przychodnia PCM
RECRUITING

Poznan, Greater Poland Voivodeship, 60-324, Poland
UCI Douglas Hospital
ACTIVE_NOT_RECRUITING

Orange, California, 92868, United States
UCI Health Center for Innovative Health Therapies
ACTIVE_NOT_RECRUITING

Orange, California, 92868, United States
UCLA
RECRUITING

Los Angeles, California, 90095, United States
UCLA Clinical & Translational Research Center (CTRC)
RECRUITING

Los Angeles, California, 90095, United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
UPMC Montefiore Clinical and Translational Research Center (CTRC)
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian Shadyside Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Universitaetsklinikum Erlangen
RECRUITING

Erlangen, Bavaria, 91054, Germany
University of California - Irvine
ACTIVE_NOT_RECRUITING

Orange, California, 92868, United States
University of Miami
RECRUITING

Miami, Florida, 33125, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Miami Dermatology Clinical Trials Unit
RECRUITING

Miami, Florida, 33136, United States
University of Ulm
RECRUITING

Ulm, Baden-Wurttemberg, 89070, Germany
University of Yamanashi Hospital
RECRUITING

Chuo-shi, Yamanashi, 409-3898, Japan
Unviversity of Miami
RECRUITING

Miami, Florida, 33136, United States
Wakayama Medical University Hospital
RECRUITING

Wakayama, 641-8510, Japan
Washington University Pulmonary Function Laboratory
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63110, United States
Washington University School of Medicine
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63110, United States
West Broward Pulmonary Consultants
RECRUITING

Plantation, Florida, 33324, United States
West Broward Rheumatology Associates
ACTIVE_NOT_RECRUITING

Tamarac, Florida, 33321, United States
West China Hospital, Sichuan University
RECRUITING

Chengdu, Sichuan, 610041, China
Xiangya Hospital Central South University
RECRUITING

Changsha, Hunan, 410008, China
Yamaguchi University Hospital
RECRUITING

Ube, Yamaguchi, 755-8505, Japan
Zaklad Diagnostyki Obrazowej HEM s.c.
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-369, Poland

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