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

Phase 2

Completed

• Conditions: Dermatomyositis
• Interventions: Drug: Anti-Beta Interferon (PF-06823859)

• Registration Number: NCT05192200
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-01
• Study Start: 2021-12-20
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-14
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-Beta Interferon drug (PF-06823859)	Anti-Beta Interferon (PF-06823859)	IV infusion

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (AEs)	Week 52
Incidence of Clinically Significant Changes In Vital Signs	Week 52
Incidence of Clinically Significant Treatment Emergent Laboratory Abnormalities	Week 52
Incidence of Clinically Significant New Electrocardiogram (ECG) Findings	Week 52

Secondary Outcome Measures

Name	Time	Method
Change in Muscle Enzyme Laboratory Values Over Time	Week 52	For muscle enzymes, the most abnormal serum muscle enzyme level at baseline (creatine kinase, aldolase, alanine transaminase, aspartate aminotransferase, lactate dehydrogenase) is used
Change Over Time In the Myositis Disease Activity Assessment Tool	Week 52	Clinical assessment completed by the physician to measure the myositis activity
Absolute Values and Change From Baseline of CDASI Damage Score	Baseline, Weeks 12, 24, 36, 48 and 52
Total Improvement Score (TIS) at Week 52 and at intermediate scheduled timepoints for participants who entered from stage 3 of protocol C0251002	Week 52
Change over time in the Patient Global Assessment PtGA	Week 52	Clinical assessment completed by the study participant of their overall disease status
Change Over Time In the Health Assessment Quality of Life and Disability Index (HAQ-DI)	Week 52	Patient reported outcome on how the study participant rate their health assessment and quality of life and disability
Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52	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.
Change Over Time In the Physician Global Assessment (PhGA)	Week 52	Clinical assessment completed by the physician of the overall disease status
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
Change over time in the Manual Muscle Testing 8 groups (MMT-8)	Week 52	Clinical assessment of muscle disease

Trial Locations

Locations (24)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Debreceni Egyetem Klinikai Kozpont; 🇭🇺 Debrecen, Hungary

Nova Reuma Społka Partnerska; 🇵🇱 Białystok, Podlaskie, Poland

Centrum Medyczne Plejady; 🇵🇱 Krakow, Poland

KU Clinical and Translational Science Unit (CTSU) Rainbow; 🇺🇸 Kansas City, Kansas, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, 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

Attune Health Research Inc.; 🇺🇸 Beverly Hills, California, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU); 🇺🇸 Fairway, Kansas, United States

Brigham and Women's Hospital - CTH; 🇺🇸 Boston, Massachusetts, United States

Center for Outpatient Health; 🇺🇸 Saint Louis, Missouri, 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

Mount Sinai Doctors Dermatology; 🇺🇸 New York, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Center for Human Phenomic Science; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM); 🇺🇸 Philadelphia, Pennsylvania, United States

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States