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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05192200
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Hungary, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dermatomyositis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Anti-Beta Interferon drug (PF-06823859)

IV infusion

Interventions

Drug: - Anti-Beta Interferon (PF-06823859)

IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Scottsdale, Arizona

Status

Not yet recruiting

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Brigham & Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham & Women's Hospital

Boston, Massachusetts, 02115

Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital - Center for Clinical Investigation

Boston, Massachusetts, 02115

Center for Outpatient Health, Saint Louis, Missouri

Status

Recruiting

Address

Center for Outpatient Health

Saint Louis, Missouri, 63108

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63108

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

New York, New York

Status

Recruiting

Address

NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology

New York, New York, 10016

New York, New York

Status

Recruiting

Address

NYU Langone Health Clinical Research Center

New York, New York, 10016

New York, New York

Status

Recruiting

Address

NYU Langone Radiology - Ambulatory Care Center East 41st Street

New York, New York, 10017

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Not yet recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10028

Mount Sinai Doctors - East 85th Street, New York, New York

Status

Not yet recruiting

Address

Mount Sinai Doctors - East 85th Street

New York, New York, 10028

Center for Human Phenomic Science, Philadelphia, Pennsylvania

Status

Recruiting

Address

Center for Human Phenomic Science

Philadelphia, Pennsylvania, 19104

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)

Philadelphia, Pennsylvania, 19104

International Sites

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Status

Recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, , 4032

Nova Reuma Społka Partnerska, Białystok, Podlaskie, Poland

Status

Recruiting

Address

Nova Reuma Społka Partnerska

Białystok, Podlaskie, 15-707

Centrum Medyczne Plejady, Krakow, Poland

Status

Not yet recruiting

Address

Centrum Medyczne Plejady

Krakow, , 30-363