An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS ≥18 AND ≤80 WITH ACTIVE DERMATOMYOSITIS.
2 other identifiers
interventional
24
4 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2021
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedResults Posted
Study results publicly available
February 6, 2025
CompletedFebruary 6, 2025
February 1, 2025
1.9 years
December 1, 2021
November 12, 2024
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment emergent relative to a given treatment if the event occurred for the first time during the effective duration of treatment and was not seen prior to the start of treatment, or the event was seen prior to the start of treatment but increased in severity during treatment. AEs included both serious adverse events (SAEs) and all non-SAEs.
From Day 1 of dosing maximum up to Week 68
Number of Participants With Laboratory Abnormalities
Hematology laboratory parameters: hemoglobin (grams per deciliter \[g/dL\]); hematocrit (percentage \[%\]); lymphocytes (10\^3 per (/) millimeter\[mm\]\^3); lymphocytes/leukocytes (%); neutrophils (10\^3/mm\^3) less than (\<)0.8\*lower limit of normal (LLN), leukocytes (10\^3/mm\^3) \<0.6\*LLN, neutrophils (10\^3/mm\^3); basophils (10\^3/mm\^3); basophils/leukocytes (%); monocytes/leukocytes (%); activated partial thromboplastin time (seconds \[sec\]); prothrombin time (sec) more than (\>)1.2\*upper limit of normal (ULN). Clinical chemistry: potassium (milliequivalents per liter \[mEq/L\]); bicarbonate (mEq/L) \<0.9\*LLN, creatine kinase (units per liter \[U/L\]) \>2.0\*ULN, glucose (milligram per deciliter \[mg/dl\]); glucose-fasting (mg/dl) \>1.5\*ULN. Urinalysis: Urine glucose; ketones; urine protein; urine hemoglobin; nitrite; leukocyte esterase; hyaline casts (1/per leukocytosis promoting factor (more than or equal to \[\>=\] 1, urine erythrocytes (scalar); urine leukocytes (scalar) \>=20.
From Day 1 of dosing maximum up to Week 68
Number of Participants According to Categorization of Changes in Vital Signs
Vital signs included the following parameters: sitting diastolic blood pressure (millimetres of mercury \[mmHg\]) change \>=20 mmHg increase; sitting systolic blood pressure (mmHg) change \>=30 mmHg increase, sitting diastolic blood pressure (mmHg) change \>=20 mmHg decrease and sitting systolic blood pressure (mmHg) change \>=30 mmHg decrease.
From Day 1 of dosing maximum up to Week 68
Number of Participants According to Categorization of Electrocardiogram (ECG) Findings
ECG parameters evaluated were: PR interval value \>=300 milliseconds (msec); QRS duration value \>=200 msec; QT interval value \>=500 msec; corrected QT Interval using Fridericia's formula (QTCF) 450 less than or equal to (\<=) value \<480 msec, 480 \<=value\<500 msec and value\>=500 msec.
From Day 1 of dosing maximum up to Week 68
Secondary Outcomes (12)
Change From Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
Baseline (before dose 1), Week 52
Change From Baseline in CDASI Activity Score at Weeks 12, 24, 36, and 48
Baseline (before dose 1), Weeks 12, 24, 36 and 48
Absolute Values of CDASI Activity Score at Weeks 12, 24, 36, 48, and 52
Weeks 12, 24, 36, 48 and 52
Change From Baseline in CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Baseline (before dose on Day 1), Weeks 12, 24, 36, 48 and 52
Absolute Values of CDASI Damage Score at Weeks 12, 24, 36, 48, and 52
Weeks 12, 24, 36, 48 and 52
- +7 more secondary outcomes
Study Arms (1)
Anti-Beta Interferon drug (PF-06823859)
EXPERIMENTALIV infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (25)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham, Department of Dermatology
Birmingham, Alabama, 35294, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Attune Health Research Inc.
Beverly Hills, California, 90211, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
Fairway, Kansas, 66205, United States
KU Clinical and Translational Science Unit (CTSU) Rainbow
Kansas City, Kansas, 66160, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital - CTH
Boston, Massachusetts, 02115, United States
Center for Outpatient Health
St Louis, Missouri, 63108, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology
New York, New York, 10016, United States
NYU Langone Health Clinical Research Center
New York, New York, 10016, United States
NYU Langone Radiology - Ambulatory Care Center East 41st Street
New York, New York, 10017, United States
Mount Sinai Doctors Dermatology
New York, New York, 10028, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Center for Human Phenomic Science
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
Philadelphia, Pennsylvania, 19104, United States
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Nova Reuma Społka Partnerska
Bialystok, Podlaskie Voivodeship, 15-707, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
January 14, 2022
Study Start
December 20, 2021
Primary Completion
November 20, 2023
Study Completion
November 20, 2023
Last Updated
February 6, 2025
Results First Posted
February 6, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.