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

Dermatomyositis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192200
• Other study ID #: C0251008
• Secondary ID: 2021-004787-10
• Status: Completed
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Dermatomyositis

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

External Links

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