AzTrials
AzTrials

MyositisPhase 3NCT05895786

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 study testing PF-06823859 in people with Myositis, run by Pfizer at 138 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myositis
What is being tested?
PF-06823859
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
318 participants
Where
138 sitesin 20 countries
Study dates
20 May 2023to 29 Jul 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

138 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

138 sites in 20 countries

United States45 sites, 35 recruiting

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia, 25801

    Active, not recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • CTC - Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • CTH - Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Integrative Rheumatology of South Texas

    Edinburg, Texas, 78539

    Recruiting

  • Arthritis & Rheumatology Research Institute, PLLC

    Frisco, Texas, 75035

    Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC

    Glendale, Arizona, 85306

    Recruiting

  • Integrative Rheumatology of South Texas

    Harlingen, Texas, 78550

    Recruiting

  • Nerve & Muscle Center of Texas

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Recruiting

  • Biopharma Informatic, LLC

    Katy, Texas, 77494

    Recruiting

  • 200 UCLA Medical Plaza

    Los Angeles, California, 90095

    Recruiting

  • UCLA Clinical & Translational Research Center (CTRC)

    Los Angeles, California, 90095

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Recruiting

  • Lal Bhagchandani, M.D

    Margate, Florida, 33063

    Active, not recruiting

  • University of Miami

    Miami, Florida, 33125

    Recruiting

  • University of Miami Dermatology Clinical Trials Unit

    Miami, Florida, 33136

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Recruiting

  • Unviversity of Miami

    Miami, Florida, 33136

    Recruiting

  • NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy

    New York, New York, 10016

    Recruiting

  • NYU Langone Health Clinical Research Center

    New York, New York, 10016

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • NYU Langone Radiology

    New York, New York, 10016

    Recruiting

  • Hospital for Special Surgery - Belaire

    New York, New York, 10021

    Not yet recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Not yet recruiting

  • RAO Research LLC

    Oklahoma City, Oklahoma, 73116

    Recruiting

  • Center for Clinical Research - Chapman Pavilion

    Orange, California, 92868

    Active, not recruiting

  • UCI Douglas Hospital

    Orange, California, 92868

    Active, not recruiting

  • UCI Health Center for Innovative Health Therapies

    Orange, California, 92868

    Active, not recruiting

  • University of California - Irvine

    Orange, California, 92868

    Active, not recruiting

  • Omega Research Orlando

    Orlando, Florida, 32808

    Active, not recruiting

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028

    Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

    Recruiting

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Montefiore Clinical and Translational Research Center (CTRC)

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Presbyterian Shadyside Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

    Recruiting

  • West Broward Pulmonary Consultants

    Plantation, Florida, 33324

    Recruiting

  • Samir Macwan, M.D., Inc.

    Rancho Mirage, California, 92270

    Recruiting

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona, 85259

    Recruiting

  • Washington University Pulmonary Function Laboratory

    St Louis, Missouri, 63110

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Active, not recruiting

  • West Broward Rheumatology Associates

    Tamarac, Florida, 33321

    Active, not recruiting

  • Pulmonary and Sleep Center of the Valley

    Weslaco, Texas, 78596

    Recruiting

Other trials in United States

China20 sites, 19 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Cangzhou People's Hospital

    Cangzhou, Hebei, 061011

    Terminated

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523016

    Recruiting

  • Dongguan People's Hospital

    Dongguan, 523059

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310002

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330036

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

    Recruiting

  • Shanghai Jiaotong University School of Medicine, Renji Hospital

    Shanghai, Shanghai Municipality, 200001

    Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai Jiaotong University School of Medicine, Renji Hospital

    Shanghai, Shanghai Municipality, 200127

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Recruiting

Other trials in China

Japan11 sites, 11 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8519

    Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • University of Yamanashi Hospital

    Chuo-shi, Yamanashi, 409-3898

    Recruiting

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

    Recruiting

  • Hospital of the university of occupational and environmental health

    Kitakyushu-shi, Fukuoka, 807-8556

    Recruiting

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, Okayama-ken, 700-8557

    Recruiting

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

    Recruiting

Other trials in Japan

Poland8 sites, 8 recruiting

  • Centrum Medycyny Oddechowej Robert Mroz spolka jawna

    Bialystok, Podlaskie Voivodeship, 15-044 Bialystok

    Recruiting

  • INTER CLINIC Piotr Adrian Klimiuk

    Bialystok, Podlaskie Voivodeship, 15-077

    Recruiting

  • Zaklad Diagnostyki Obrazowej HEM s.c.

    Bialystok, Podlaskie Voivodeship, 15-369

    Recruiting

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, Podlaskie Voivodeship, 15-707

    Recruiting

  • Małopolskie Centrum Kliniczne

    Krakow, Lesser Poland Voivodeship, 30-149

    Recruiting

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363

    Recruiting

  • Twoja Przychodnia PCM

    Poznan, Greater Poland Voivodeship, 60-324

    Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, Masovian Voivodeship, 02-637

    Recruiting

Other trials in Poland

Mexico6 sites, 6 recruiting

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Mexico City, 06100

    Recruiting

  • Private Practice - Dr. Miguel Cortes

    Cuernavaca, Morelos, 62448

    Recruiting

  • Boca Clinical Trials Mexico S.C.

    Guadajalara, Jalisco, 44600

    Recruiting

  • Centro Integral en Reumatologia

    Guadalajara, Jalisco, 44160

    Recruiting

  • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

    Mexico City, Mexico City, 06700

    Recruiting

  • CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

    Mexico City, 06700

    Recruiting

Other trials in Mexico

Taiwan6 sites, 6 recruiting

  • China Medical University Hospital

    Taichung, 404332

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • Chi Mei Medical Center

    Tainan, Tainan, 71004

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

South Korea5 sites, 5 recruiting

  • Chonnam National University Hospital

    Gwangju, 61469

    Recruiting

  • Kyung Hee University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 02447

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 04763

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499

    Recruiting

Other trials in South Korea

Argentina4 sites, 4 recruiting

  • Instituto de Reumatología Medical Center S.A.

    Mendoza, 5500

    Recruiting

  • CER medical Institute

    Quilmes, Buenos Aires F.D., B1878

    Recruiting

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, Tucumán Province, T4000AXL

    Recruiting

  • Alto Dorrego

    Villa Nueva, Mendoza Province, 5513

    Recruiting

Other trials in Argentina

France4 sites, 4 recruiting

  • Hôpital Edouard Herriot

    Lyon, 69003

    Recruiting

  • Hôpitaux Universitaires Pitie Salpetriere AP-HP - CRMR des Myopathies Inflammatoires

    Paris, 75013

    Recruiting

  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

    Reims, 51092

    Recruiting

  • Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil

    Strasbourg, 67091

    Recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania

    Catania, 95121

    Recruiting

  • Irccs Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

    Recruiting

Other trials in Italy

Spain4 sites, 4 recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, Comunidad de, 28031

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320

    Recruiting

Other trials in Spain

Germany3 sites, 3 recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, Bavaria, 91054

    Recruiting

  • Ludwig Maximilians University Munich Klinikum

    München, 80336

    Recruiting

  • University of Ulm

    Ulm, Baden-Wurttemberg, 89070

    Recruiting

Other trials in Germany

India3 sites, 3 recruiting

  • Medanta-The Medicity

    Gurugram (Gurgaon), Haryana, 122001

    Recruiting

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    Kochi, Kerala, 682040

    Recruiting

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    Kolkata, West Bengal, 700020

    Recruiting

Other trials in India

Israel3 sites, 3 recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906

    Recruiting

Other trials in Israel

Turkey (Türkiye)3 sites, 3 recruiting

  • Ankara University Ibni Sina Hospital

    Ankara, 06230

    Recruiting

  • Hacettepe Universite Hastaneleri

    Ankara, 06230

    Recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom3 sites, 3 recruiting

  • Doncaster Royal Infirmary

    Doncaster, DN2 5LT

    Recruiting

  • Queen Elizabeth University Hospital

    Glasgow, Glasgow CITY, G51 4TF

    Recruiting

  • Salford Royal Hospital

    Salford, Manchester, M6 8HD

    Recruiting

Other trials in United Kingdom

Bulgaria2 sites, 2 recruiting

  • Medical Center Artmed

    Plovdiv, 4002

    Recruiting

  • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD

    Sofia, Sofia (stolitsa), 1463

    Recruiting

Other trials in Bulgaria

Hungary2 sites, 2 recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632

    Recruiting

Other trials in Hungary

Slovakia1 site, 1 recruiting

  • Narodny ustav reumatickych chorob

    Piešťany, 921 12

    Recruiting

Other trials in Slovakia

Sweden1 site, 1 recruiting

  • Karolinska University Hospital Solna

    Stockholm, 17164

    Recruiting

Other trials in Sweden

About this study

Official title: 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:

Read more
  • 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
Myositis
Being tested
PF-06823859, Placebo
Keywords
Dermatomyositis, Polymyositis
Medical subject headings
Myositis, Dermatomyositis, Polymyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06823859Drug

    anti-interferon beta therapy

  • PlaceboDrug

    Placebo for PF-06823859

Study groups in NCT05895786
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo via intravenous infusion every 4 weeks.
Receives: Drug: Placebo
PF-06823859ExperimentalParticipants will receive PF-06823859 via intravenous infusion every 4 weeks.
Receives: Drug: PF-06823859

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Moderate change in Total Improvement Score (TIS)

    Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

    Measured: 24 weeks outside of the United States (US) and 52 weeks in the US

Secondary outcomes (9)

  1. 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

    Measured: 24 weeks outside of the US and 52 weeks in the US

  2. 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.

    Measured: Week 24 outside the US

  3. 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

    Measured: 24 and 52 weeks in the US only

  4. Corticosteroid (CS) dose assessment

    Normalized Area Under the Curve (AUC) of corticosteroid dose

    Measured: 52 weeks

  5. Moderate change in Total Improvement Score

    Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

    Measured: 24 weeks in the US and 52 weeks outside of the US

  6. 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

    Measured: 24 weeks outside of the US and 52 weeks in the US

  7. 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.

    Measured: 24 weeks outside of the US and 52 weeks in the US

  8. 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

    Measured: 24 weeks outside of the US and 52 weeks in the US

  9. 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.

    Measured: 52 weeks US only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start20 May 2023
  3. Primary completion29 Jul 2030 (estimated)
  4. Study completion29 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, parallel-group study to assess whether the study medicine will work to lessen muscle weakness and skin symptoms in adults with active polymyositis (PM) or dermatomyositis (DM). Eligible participants are required to have active disease at the time of enrollment and are required to enter the study on protocol-permitted standard of care (SOC) background medication. The study will be conducted in 2 parallel cohorts: Cohort 1 (DM) and Cohort 2 (PM).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05895786
Sponsor's protocol ID
C0251006
Other IDs
2022-502739-20-00
Status last verified
Sep 2026
First submitted
27 Apr 2023
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-06823859 in people with Myositis, run by Pfizer at 138 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, China, Japan, Poland, Mexico and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate change in Total Improvement Score (TIS) (time frame: 24 weeks outside of the United States (US) and 52 weeks in the US). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05895786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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