RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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 (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 15 study visits. These visits will be performed at the study site.

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)

Quick Facts

Study Start:2023-05-20
Study Completion:2026-07-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05895786

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female adults (≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)
  2. * Active dermatomyositis (DM) or polymyositis (PM) with age of onset
  3. * 18 years old.
  4. * Must be receiving a stable dose of standard of care (SOC) background medications at the time of enrollment.
  1. * Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)
  2. * Existing diagnosis of inclusion body myositis (IBM)
  3. * Presence of immune-mediated necrotizing myositis (IMNM)
  4. * Myositis with end-stage organ involvement
  5. * Active bacterial, viral or fungal infections or hospitalizations for serious infections within 60 days prior to enrollment
  6. * History of recurrent bacterial, viral, fungal, mycobacterial or other infections
  7. * Clinically significant finding on a chest x-ray
  8. * Have cancer or a history of cancer within 5 years of screening
  9. * Significant current or prior disease conditions that may interfere with the response to or safety of the study medicine, including but not limited to:
  10. * history of major organ transplant
  11. * acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening
  12. * preexisting demyelinating disorder such as multiple sclerosis, or other severe neurological disorder
  13. * major surgery within 4 weeks of screening, or scheduled to occur during the study, excluding diagnostic surgery
  14. * previous treatment with total lymphoid irradiation
  15. * history of any lymphoproliferative disorder such as Epstein Barr Virus, history of lymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease
  16. * Clinically significant depression, suicidal ideation, or previous history of suicidal behaviors
  17. * Other medical or laboratory abnormality that may increase the risk of study participation
  18. * Previous administration with an investigational product (drug or vaccine) within 30 days or of the first dose of study medicine
  19. * 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
  20. * Prior SOC medication that does not fulfill the criteria
  21. * Certain laboratory results from screening assessments that may interfere with study participation.
  22. * 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

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates- Glendale
Glendale, Arizona, 85306
United States
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, 85306
United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, 85259
United States
200 UCLA Medical Plaza
Los Angeles, California, 90095
United States
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, 90095
United States
UCLA
Los Angeles, California, 90095
United States
Center for Clinical Research - Chapman Pavilion
Orange, California, 92868
United States
UCI Douglas Hospital
Orange, California, 92868
United States
UCI Health Center for Innovative Health Therapies
Orange, California, 92868
United States
University of California - Irvine
Orange, California, 92868
United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786
United States
University of Miami
Coral Gables, Florida, 33136
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Lal Bhagchandani, M.D
Margate, Florida, 33063
United States
University of Miami Dermatology Clinical Trials Unit
Miami, Florida, 33125
United States
University of Miami
Miami, Florida, 33125
United States
Omega Research Orlando
Orlando, Florida, 32808
United States
IRIS Research and Development, LLC
Plantation, Florida, 33324
United States
West Broward Pulmonary Consultants
Plantation, Florida, 33324
United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321
United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, 66205
United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, 66205
United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas, 66160
United States
University of Kansas Medical Center - Hoglund Brain Imaging Center
Kansas City, Kansas, 66160
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
CTH - Brigham & Women's Hospital
Boston, Massachusetts, 02115
United States
Washington University School of Medicine
Saint Louis, Missouri, 63108
United States
Washington University Pulmonary Function Laboratory
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201
United States
NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy
New York, New York, 10016
United States
NYU Langone Health Clinical Research Center
New York, New York, 10016
United States
NYU Langone Health
New York, New York, 10016
United States
NYU Langone Rad1ology
New York, New York, 10016
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Arthritis & Rheumatology Research Institute
Allen, Texas, 75013
United States
Integrative Rheumatology of South Texas
Edinburg, Texas, 78539
United States
Integrative Rheumatology of South Texas - Harlingen
Harlingen, Texas, 78550
United States
DLCO
Houston, Texas, 77030
United States
Nerve & Muscle Center of Texas
Houston, Texas, 77030
United States
Pulmonary and Sleep Center of the Valley
Weslaco, Texas, 78596
United States
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

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 Registration Dates

Study Start Date2023-05-20
Study Completion Date2026-07-23

Study Record Updates

Study Start Date2023-05-20
Study Completion Date2026-07-23

Terms related to this study

Keywords Provided by Researchers

  • Dermatomyositis
  • Polymyositis

Additional Relevant MeSH Terms

  • Myositis