Status:
COMPLETED
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
Lead Sponsor:
Pfizer
Conditions:
Dermatomyositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05192200
Start Date
December 20 2021
End Date
November 20 2023
Last Update
February 6 2025
Active Locations (25)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, United States, 35294
3
Mayo Clinic
Scottsdale, Arizona, United States, 85259
4
Attune Health Research Inc.
Beverly Hills, California, United States, 90211