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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05192200
Other study ID # C0251008
Secondary ID 2021-004787-10
Status Completed
Phase Phase 2
First received
Last updated
Start date December 20, 2021
Est. completion date November 20, 2023

Study information

Verified date February 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 20, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Poland Nova Reuma Spolka Partnerska Bialystok Podlaskie
Poland Centrum Medyczne Plejady Krakow
Spain Hospital Universitario 12 de Octubre Madrid
United States Attune Health Research Inc. Beverly Hills California
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Alabama at Birmingham, Department of Dermatology Birmingham Alabama
United States Brigham & Women's Hospital Boston Massachusetts
United States Brigham and Women's Hospital - CTH Boston Massachusetts
United States Cleveland Clinic Foundation Cleveland Ohio
United States KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Fairway Kansas
United States Mayo Clinic in Florida Jacksonville Florida
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 Icahn School of Medicine at Mount Sinai New York New York
United States Mount Sinai Doctors Dermatology New York New York
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 Center for Human Phenomic Science Philadelphia Pennsylvania
United States University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM) Philadelphia Pennsylvania
United States Center for Outpatient Health Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment Emergent Adverse Events (AEs) Week 52
Primary Incidence of Clinically Significant Treatment Emergent Laboratory Abnormalities Week 52
Primary Incidence of Clinically Significant Changes In Vital Signs Week 52
Primary Incidence of Clinically Significant New Electrocardiogram (ECG) Findings Week 52
Secondary Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52 The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), a skin-based outcome measure, was developed to systematically assess the extent of cutaneous disease in patients with DM.
The CDASI scale is a validated DM-specific instrument designed to capture the extent of cutaneous disease. Disease involvement in 15 different anatomical locations is rated using three activity (erythema, scale, erosion/ulceration) and two damage (poikiloderma, calcinosis) measures. The presence and severity of Gottron's papules, periungual changes and alopecia are also captured. The resulting activity and damage scores range from 0 to 100 and 0 to 32, respectively. Higher scores indicate greater disease severity.
Week 52
Secondary Absolute Values and Change From Baseline of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Scores Baseline, Weeks 12, 24, 36, 48 and 52
Secondary Absolute Values and Change From Baseline of CDASI Damage Score Baseline, Weeks 12, 24, 36, 48 and 52
Secondary Total Improvement Score (TIS) at Week 52 and at intermediate scheduled timepoints for participants who entered from stage 3 of protocol C0251002 Week 52
Secondary Change Over Time In the Physician Global Assessment (PhGA) Clinical assessment completed by the physician of the overall disease status Week 52
Secondary Change over time in the Patient Global Assessment PtGA Clinical assessment completed by the study participant of their overall disease status Week 52
Secondary Change over time in the Manual Muscle Testing 8 groups (MMT-8) Clinical assessment of muscle disease Week 52
Secondary Change Over Time In the Health Assessment Quality of Life and Disability Index (HAQ-DI) Patient reported outcome on how the study participant rate their health assessment and quality of life and disability Week 52
Secondary Change in Muscle Enzyme Laboratory Values Over Time For muscle enzymes, the most abnormal serum muscle enzyme level at baseline (creatine kinase, aldolase, alanine transaminase, aspartate aminotransferase, lactate dehydrogenase) is used Week 52
Secondary Change Over Time In the Myositis Disease Activity Assessment Tool Clinical assessment completed by the physician to measure the myositis activity Week 52
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