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

Myositis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895786
• Other study ID #: C0251006
• Secondary ID: 2022-502739-20-0
• Status: Recruiting
• Phase: Phase 3
• Start date: May 20, 2023
• Est. completion date: December 4, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 4, 2025
• Est. primary completion date: December 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Myositis
• Polymyositis

Intervention

Drug:
• PF-06823859
anti-interferon beta therapy
• Placebo
Placebo for PF-06823859

Locations

Country	Name	City	State
Argentina	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Belgium	UZ Leuven	Leuven	Vlaams-brabant
Bulgaria	Medical Center Artmed	Plovdiv
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Cangzhou People's Hospital	Cangzhou	Hebei
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Cheng Du	Sichuan
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The first Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan Sheng
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
France	Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche	Reims
France	Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil	Strasbourg
Germany	Ludwig Maximilians University Munich Klinikum	Munchen	Bavaria
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
India	Institute of Neurosciences	Surat	Gujarat
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Tokyo Medical And Dental University Hospital	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachinagano	Osaka
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama-shi	Okayama
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama-shi	Okayama
Japan	Shiga University of Medical Science Hospital	Otsu	Shiga
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Korea, Republic of	Chonnam National University Bitgoeul Hospital	Gwangju	Kwangju-kwangyokshi
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Centrum Medycyny Oddechowej Robert Mroz spolka jawna	Bialystok	Podlaskie
Poland	INTER CLINIC Piotr Adrian Klimiuk	Bialystok	Podlaskie
Poland	Nova Reuma Spolka Partnerska	Bialystok	Podlaskie
Poland	Zaklad Diagnostyki Obrazowej HEM s.c.	Bialystok	Podlaskie
Poland	Centrum Medyczne Plejady	Krakow	Malopolskie
Poland	5 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ	Kraków	Malopolskie
Poland	5 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ	Kraków	Malopolskie
Poland	Lux Med	Kraków	Malopolskie
Poland	Malopolskie Centrum Kliniczne	Kraków	Malopolskie
Poland	Pracownia Radiologiczna WIDOK-MED	Kraków	Malopolskie
Slovakia	Narodny ustav reumatickych chorob	Pieštany
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario QuironSalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Arthritis and Rheumatology Research Institute	Allen	Texas
United States	Rheumatology & Pulmonary Clinic	Beckley	West Virginia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	CTH - Brigham & Women's Hospital	Boston	Massachusetts
United States	Joseph S. and Diane H. Steinberg Ambulatory Care Center	Brooklyn	New York
United States	University of Miami	Coral Gables	Florida
United States	KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)	Fairway	Kansas
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
United States	Arizona Arthritis & Rheumatology Research, PLLC	Glendale	Arizona
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kansas Medical Center - Hoglund Brain Imaging Center	Kansas City	Kansas
United States	Lal Bhagchandani, M.D	Margate	Florida
United States	University of Miami	Miami	Florida
United States	University of Miami Dermatology Clinical Trials Unit	Miami	Florida
United States	Center for Clinical Research - Chapman Pavilion	Orange	California
United States	UCI Douglas Hospital	Orange	California
United States	UCI Health Center for Innovative Health Therapies	Orange	California
United States	University of California - Irvine	Orange	California
United States	Omega Research Orlando	Orlando	Florida
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	Washington University Pulmonary Function Laboratory	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic in Arizona - Scottsdale	Scottsdale	Arizona
United States	West Broward Rheumatology Associates	Tamarac	Florida
United States	Inland Rheumatology & Osteoporosis Medical Group	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Bulgaria,  China,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate change in Total Improvement Score (TIS)	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	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	24 weeks outside of the US and 52 weeks in the US
Secondary	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.	Week 24 outside the US
Secondary	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	24 and 52 weeks in the US only
Secondary	Corticosteroid (CS) dose assessment	Normalized Area Under the Curve (AUC) of corticosteroid dose	52 weeks
Secondary	Moderate change in Total Improvement Score	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
Secondary	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	24 weeks outside of the US and 52 weeks in the US
Secondary	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.	24 weeks outside of the US and 52 weeks in the US
Secondary	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	24 weeks outside of the US and 52 weeks in the US
Secondary	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.	52 weeks US only

External Links

•   To obtain contact information for a study center near you, click here.