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

Primary Purpose

Myositis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-06823859
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myositis focused on measuring Dermatomyositis, Polymyositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Arthritis & Rheumatology Associates, P.C.Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLCRecruiting
  • Inland Rheumatology & Osteoporosis Medical GroupRecruiting
  • Lal Bhagchandani, M.D
  • Omega Research OrlandoRecruiting
  • West Broward Rheumatology Associates
  • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
  • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
  • University of Kansas Medical Center - Hoglund Brain Imaging Center
  • University of Kansas Medical Center
  • Brigham and Women's Hospital
  • CTH - Brigham & Women's Hospital
  • Washington University School of MedicineRecruiting
  • Washington University Pulmonary Function LaboratoryRecruiting
  • Washington University School of MedicineRecruiting
  • Arthritis and Rheumatology Research InstituteRecruiting
  • Rheumatology & Pulmonary ClinicRecruiting
  • Anhui Provincial Hospital
  • China-Japan Friendship Hospital
  • Peking Union Medical College Hospital
  • Guangdong Provincial People's Hospital
  • Guangdong Provincial People's Hospital
  • Qilu Hospital of Shandong University
  • Shanghai Jiaotong University School of Medicine, Renji Hospital
  • National Hospital Organization Asahikawa Medical Center
  • National Hospital Organization Asahikawa Medical Center
  • Hokkaido University HospitalRecruiting
  • Tokyo Medical And Dental University Hospital
  • Nippon Medical School HospitalRecruiting
  • Tokyo Medical University Hospital
  • Okayama City General Medical Center Okayama City Hospital
  • Tokyo Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-06823859

Placebo

Arm Description

Participants will receive PF-06823859 via intravenous infusion every 4 weeks.

Participants will receive placebo via intravenous infusion every 4 weeks.

Outcomes

Primary Outcome Measures

Moderate change in Total Improvement Score (TIS)
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.

Secondary Outcome Measures

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
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.
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
Corticosteroid (CS) dose assessment
Normalized Area Under the Curve (AUC) of corticosteroid dose
Moderate change in Total Improvement Score
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
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
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.
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
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.

Full Information

First Posted
April 27, 2023
Last Updated
October 6, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05895786
Brief Title
A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
December 4, 2025 (Anticipated)
Study Completion Date
December 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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, but some study visits may be available at home or via mobile clinic if the study location participates in this option.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myositis
Keywords
Dermatomyositis, Polymyositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The sponsor, participants, site personnel, including the investigator with be masked to study treatment and will not know whether active study medication or placebo is being administered to participants.
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PF-06823859
Arm Type
Experimental
Arm Description
Participants will receive PF-06823859 via intravenous infusion every 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo via intravenous infusion every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
PF-06823859
Intervention Description
anti-interferon beta therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for PF-06823859
Primary Outcome Measure Information:
Title
Moderate change in Total Improvement Score (TIS)
Description
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Time Frame
24 weeks outside of the United States (US) and 52 weeks in the US
Secondary Outcome Measure Information:
Title
Change from baseline in Manual Muscle Testing - 8 designated muscles (MMT-8)
Description
Manual Muscle Testing (8 designated muscles) 0 to 150 with higher scores indicating a better outcome
Time Frame
24 weeks outside of the US and 52 weeks in the US
Title
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) in participants with dermatomyositis (DM)
Description
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.
Time Frame
Week 24 outside the US
Title
Change from baseline in Investigator Global Assessment severity scale (IGA) in participants with dermatomyositis
Description
Investigator Global Assessment severity scale 0 to 4 with higher scores indicating a worse outcome. Only participants with baseline IGA ≥2 will be assessed
Time Frame
24 and 52 weeks in the US only
Title
Corticosteroid (CS) dose assessment
Description
Normalized Area Under the Curve (AUC) of corticosteroid dose
Time Frame
52 weeks
Title
Moderate change in Total Improvement Score
Description
Total Improvement Score 0 to 100 with higher scores indicating a better outcome.
Time Frame
24 weeks in the US and 52 weeks outside of the US
Title
Change from baseline in Patient-Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF)
Description
Patient-Reported Outcomes Measurement Information System - Physical Function 0 to 100 with higher scores indicating a better outcome
Time Frame
24 weeks outside of the US and 52 weeks in the US
Title
Change from baseline in 5-D Itch Scale Score
Description
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.
Time Frame
24 weeks outside of the US and 52 weeks in the US
Title
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Description
Functional Assessment of Chronic Illness Therapy - Fatigue 0 to 52 with higher scores indicating a better outcome
Time Frame
24 weeks outside of the US and 52 weeks in the US
Title
Response in corticosteroid tapering
Description
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.
Time Frame
52 weeks US only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Rheumatology & Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Lal Bhagchandani, M.D
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Omega Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Name
West Broward Rheumatology Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Kansas Medical Center - Hoglund Brain Imaging Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
CTH - Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University Pulmonary Function Laboratory
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatology Research Institute
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology & Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanghai Jiaotong University School of Medicine, Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Not yet recruiting
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
0700901
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical And Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C0251006
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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