An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study

Completed · Phase 2

Conditions studied: Dermatomyositis

In brief

The purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.

Key facts

Study ID

NCT05192200

Run by

Pfizer

People needed

24

Starts

2021-12-20

Expected to finish

2023-11-20

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged ≥18 and ≤80 with moderate to severe dermatomyositis (DM), that have completed the treatment period of a qualifying study.
• Capable of giving signed informed consent.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

You may not qualify if…

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
• Participants who met discontinuation criteria at any point during the participating qualifying studies.
• Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has not resolved.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Alabama at Birmingham, Department of Dermatology — Birmingham, Alabama, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Attune Health Research Inc. — Beverly Hills, California, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) — Fairway, Kansas, United States
• KU Clinical and Translational Science Unit (CTSU) Rainbow — Kansas City, Kansas, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital - CTH — Boston, Massachusetts, United States
• Center for Outpatient Health — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology — New York, New York, United States
• NYU Langone Health Clinical Research Center — New York, New York, United States
• NYU Langone Radiology - Ambulatory Care Center East 41st Street — New York, New York, United States
• Mount Sinai Doctors Dermatology — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Center for Human Phenomic Science — Philadelphia, Pennsylvania, United States
• University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM) — Philadelphia, Pennsylvania, United States
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Nova Reuma Społka Partnerska — Bialystok, Podlaskie Voivodeship, Poland
• Centrum Medyczne Plejady — Krakow, Poland
• Hospital Universitario 12 de Octubre — Madrid, Spain

Full record on ClinicalTrials.gov

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