CompletedPhase 2
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
Key facts
- Who runs it
- Pfizer
- Where
- Beverly Hills, Birmingham, Boston, Cleveland, Fairway, Jacksonville, Kansas City, New York, Philadelphia, Scottsdale, and St Louis, United StatesSee the 20 sitesAlso in 3 other countries, 4 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 24 people enrolled
- Started
- 20 Dec 2021
- Ended
- 20 Nov 2023
- Type of study
- Interventional
- Treatments tested
- Anti-Beta Interferon (PF-06823859)
- Record updated
- 6 February 2025
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
Also in 3 other countries, 4 sites
- Attune Health Research IncBeverly Hills, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- University of Alabama at Birmingham - Department of DermatologyBirmingham, United StatesNo longer taking part
- Brigham & Women's HospitalBoston, United StatesNo longer taking part
- Brigham and Women's Hospital - CTHBoston, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)Fairway, United StatesNo longer taking part
- Mayo Clinic in FloridaJacksonville, United StatesNo longer taking part
- KU Clinical and Translational Science Unit (CTSU) RainbowKansas City, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, United StatesNo longer taking part
- Mount Sinai Doctors DermatologyNew York, United StatesNo longer taking part
- NYU Grossman School of Medicine, The Ronald O. Perelman Department of DermatologyNew York, United StatesNo longer taking part
- NYU Langone Health Clinical Research CenterNew York, United StatesNo longer taking part
- NYU Langone Radiology - Ambulatory Care Center East 41st StreetNew York, United StatesNo longer taking part
- Center for Human Phenomic SciencePhiladelphia, United StatesNo longer taking part
- University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)Philadelphia, United StatesNo longer taking part
- Mayo ClinicScottsdale, United StatesNo longer taking part
- Center for Outpatient HealthSt Louis, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Anti-Beta Interferon drug (PF-06823859)Treatment being tested
IV infusion
Treatment: Anti-Beta Interferon (PF-06823859)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS ≥18 AND ≤80 WITH ACTIVE DERMATOMYOSITIS.
- Publications
- Record updated
- 6 February 2025