A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

March 17, 2024 updated by: Pfizer

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 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.
  • 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 (PF-06823859) 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 about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 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 PF-06823859 is safe and effective.

Participants will take part in this study for about 13 months. During this time, participants will have 16 study visits. These visits will be performed at the study site.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Vlaams-brabant
      • Leuven, Vlaams-brabant, Belgium, 3000
        • Not yet recruiting
        • UZ Leuven
      • Plovdiv, Bulgaria, 4000
        • Not yet recruiting
        • Medical Center Artmed
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
    • Hebei
      • Cangzhou, Hebei, China, 061011
        • Recruiting
        • Cangzhou People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • Xiangya Hospital Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
    • Shandong
      • Jinan, Shandong, China, 250014
        • Recruiting
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Jiaotong University School of Medicine, Renji Hospital
      • Shanghai, Shanghai, China, 200040
        • Not yet recruiting
        • Huashan Hospital, Fudan University
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
    • Yunnan Sheng
      • Kunming, Yunnan Sheng, 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
      • Reims, France, 51092
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
      • Strasbourg, France, 67091
        • Not yet recruiting
        • Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Okayama, Japan, 700-8557
        • Recruiting
        • Okayama City General Medical Center Okayama City Hospital
      • Tokyo, Japan, 160-0023
        • Not yet recruiting
        • Tokyo Medical University Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8644
        • Not yet recruiting
        • National Hospital Organization Asahikawa Medical Center
      • Asahikawa, Hokkaido, Japan, 0700901
        • Not yet recruiting
        • National Hospital Organization Asahikawa Medical Center
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Not yet recruiting
        • St. Marianna University School of Medicine Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8557
        • Recruiting
        • Okayama City General Medical Center Okayama City Hospital
      • Okayama-shi, Okayama, Japan, 700-8557
        • Not yet recruiting
        • Okayama City General Medical Center Okayama City Hospital
    • Osaka
      • Kawachinagano, Osaka, Japan, 586-8521
        • Recruiting
        • National Hospital Organization Osaka Minami Medical Center
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Recruiting
        • Tokyo Medical and Dental University Hospital
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
    • Kwangju-kwangyokshi
      • Gwangju, Kwangju-kwangyokshi, Korea, Republic of, 61748
        • Recruiting
        • Chonnam National University Bitgoeul Hospital
    • Małopolskie
      • Krakow, Małopolskie, Poland, 30-363
        • Not yet recruiting
        • Centrum Medyczne Plejady
      • Kraków, Małopolskie, Poland, 30-147
        • Recruiting
        • Pracownia Radiologiczna WIDOK-MED
      • Kraków, Małopolskie, Poland, 30-149
        • Recruiting
        • Małopolskie Centrum Kliniczne
      • Kraków, Małopolskie, Poland, 30-901
        • Recruiting
        • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
      • Kraków, Małopolskie, Poland, 30-415
        • Not yet recruiting
        • Lux Med
      • Kraków, Małopolskie, Poland, 30-901
        • Not yet recruiting
        • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-707
        • Not yet recruiting
        • Nova Reuma Społka Partnerska
      • Bialystok, Podlaskie, Poland, 15-044 Bialystok
        • Recruiting
        • Centrum Medycyny Oddechowej Robert Mroz spolka jawna
      • Białystok, Podlaskie, Poland, 15-077
        • Recruiting
        • INTER CLINIC Piotr Adrian Klimiuk
      • Białystok, Podlaskie, Poland, 15-369
        • Recruiting
        • Zaklad Diagnostyki Obrazowej HEM s.c.
      • Piešťany, Slovakia, 921 12
        • Not yet recruiting
        • Narodny ustav reumatickych chorob
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 De Octubre
      • Sevilla, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Not yet recruiting
        • Hospital Universitario Quirónsalud Madrid
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Taipei Veterans General Hospital
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Research, PLLC
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P.C.
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic in Arizona - Scottsdale
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California - Irvine
      • Orange, California, United States, 92868
        • Recruiting
        • Center for Clinical Research - Chapman Pavilion
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Douglas Hospital
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health Center for Innovative Health Therapies
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology & Osteoporosis Medical Group
    • Florida
      • Coral Gables, Florida, United States, 33136
        • Recruiting
        • University of Miami
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
      • Margate, Florida, United States, 33063
        • Recruiting
        • Lal Bhagchandani, M.D
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of Miami
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of Miami Dermatology Clinical Trials Unit
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research Orlando
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Not yet recruiting
        • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
      • Kansas City, Kansas, United States, 66160
        • Not yet 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
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University Pulmonary Function Laboratory
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • Joseph S. and Diane H. Steinberg Ambulatory Care Center
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Arthritis and Rheumatology Research Institute
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Recruiting
        • Rheumatology & Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female adults (≥18 years old)
  • 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
  • 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 l 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
  • 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), including 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-06823859
Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
anti-interferon beta therapy
Placebo Comparator: Placebo
Participants will receive placebo via intravenous infusion every 4 weeks.
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)
Time Frame: 24 weeks outside of the United States (US) and 52 weeks in the US
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)
Time Frame: 24 weeks outside of the US and 52 weeks in the US
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 Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)
Time Frame: Week 24 outside the US
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 Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis
Time Frame: 24 and 52 weeks in the US only
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
Time Frame: 52 weeks
Normalized Area Under the Curve (AUC) of corticosteroid dose
52 weeks
Moderate change in Total Improvement Score
Time Frame: 24 weeks in the US and 52 weeks outside of the US
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)
Time Frame: 24 weeks outside of the US and 52 weeks in the US
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 5-D Itch Scale Score
Time Frame: 24 weeks outside of the US and 52 weeks in the US
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
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time Frame: 24 weeks outside of the US and 52 weeks in the US
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
Time Frame: 52 weeks US only
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2023

Primary Completion (Estimated)

December 4, 2025

Study Completion (Estimated)

December 4, 2025

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)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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