Clinical trial NCT05192200: An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatomyositis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Day 1 of dosing maximum up to Week 68
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From Day 1 of dosing maximum up to Week 68
measure: Number of Participants According to Categorization of Changes in Vital Signs
timeFrame: From Day 1 of dosing maximum up to Week 68
measure: Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
timeFrame: From Day 1 of dosing maximum up to Week 68
Secondary outcomes:
measure: Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
timeFrame: Baseline (before dose 1), Week 52
measure: Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
timeFrame: Baseline (before dose 1), Weeks 12, 24, 36 and 48
measure: Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
timeFrame: Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
timeFrame: Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
measure: Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
timeFrame: Weeks 12, 24, 36, 48 and 52
measure: Total Improvement Score (TIS) at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Physician Global Assessment (PhGA) Score at Week 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Patient Global Assessment (PtGA) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Manual Muscle Testing-8 Designated Muscle Groups (MMT-8) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Health Assessment Questionnaire and Disease Index (HAQ-DI) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Creatine Kinase at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
measure: Change From Baseline in Extramuscular Global Assessment From the Myositis Disease Activity Assessment Tool (MDAAT) Score at Weeks 12, 24, 36, 48 and 52: Muscle Cohort
timeFrame: Baseline (before dose on day 1), Weeks 12, 24, 36, 48 and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, Department of Dermatology
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Beverly Hills
country: United States
facility: Attune Health Research Inc.
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Fairway
country: United States
facility: KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
state: Kansas
city: Kansas City
country: United States
facility: KU Clinical and Translational Science Unit (CTSU) Rainbow
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital - CTH
state: Massachusetts
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology
state: New York
city: New York
country: United States
facility: NYU Langone Health Clinical Research Center
state: New York
city: New York
country: United States
facility: NYU Langone Radiology - Ambulatory Care Center East 41st Street
state: New York
city: New York
country: United States
facility: Mount Sinai Doctors Dermatology
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Center for Human Phenomic Science
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
state: Pennsylvania
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Białystok
country: Poland
facility: Nova Reuma Społka Partnerska
state: Podlaskie
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: