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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Dermatomyositis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti-Beta Interferon drug (PF-06823859)

IV infusion

Group Type EXPERIMENTAL

Anti-Beta Interferon (PF-06823859)

Intervention Type DRUG

IV infusion

Interventions

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Anti-Beta Interferon (PF-06823859)

IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham, Department of Dermatology

Birmingham, Alabama, United States

Site Status

Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Attune Health Research Inc.

Beverly Hills, California, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)

Fairway, Kansas, United States

Site Status

KU Clinical and Translational Science Unit (CTSU) Rainbow

Kansas City, Kansas, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital - CTH

Boston, Massachusetts, United States

Site Status

Center for Outpatient Health

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status