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

Primary Purpose

Dermatomyositis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anti-Beta Interferon (PF-06823859)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham, Department of Dermatology
  • Mayo Clinic
  • Attune Health Research Inc.
  • Mayo Clinic in Florida
  • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
  • KU Clinical and Translational Science Unit (CTSU) Rainbow
  • University of Kansas Medical Center
  • Brigham & Women's Hospital
  • Brigham and Women's Hospital - CTH
  • Center for Outpatient Health
  • Washington University School of Medicine
  • Washington University School of Medicine
  • NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology
  • NYU Langone Health Clinical Research Center
  • NYU Langone Radiology - Ambulatory Care Center East 41st Street
  • Mount Sinai Doctors Dermatology
  • Cleveland Clinic Foundation
  • Center for Human Phenomic Science
  • University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
  • Debreceni Egyetem Klinikai Kozpont
  • Nova Reuma Społka Partnerska
  • Centrum Medyczne Plejady
  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-Beta Interferon drug (PF-06823859)

Arm Description

IV infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Absolute Values and Change From Baseline of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Scores
Absolute Values and Change From Baseline of CDASI Damage Score
Total Improvement Score (TIS) at Week 52 and at intermediate scheduled timepoints for participants who entered from stage 3 of protocol C0251002
Change Over Time In the Physician Global Assessment (PhGA)
Clinical assessment completed by the physician of the overall disease status
Change over time in the Patient Global Assessment PtGA
Clinical assessment completed by the study participant of their overall disease status
Change over time in the Manual Muscle Testing 8 groups (MMT-8)
Clinical assessment of muscle disease
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
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
Change Over Time In the Myositis Disease Activity Assessment Tool
Clinical assessment completed by the physician to measure the myositis activity

Full Information

First Posted
December 1, 2021
Last Updated
September 15, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05192200
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
November 24, 2023 (Anticipated)
Study Completion Date
November 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-Beta Interferon drug (PF-06823859)
Arm Type
Experimental
Arm Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Anti-Beta Interferon (PF-06823859)
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (AEs)
Time Frame
Week 52
Title
Incidence of Clinically Significant Treatment Emergent Laboratory Abnormalities
Time Frame
Week 52
Title
Incidence of Clinically Significant Changes In Vital Signs
Time Frame
Week 52
Title
Incidence of Clinically Significant New Electrocardiogram (ECG) Findings
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
Description
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.
Time Frame
Week 52
Title
Absolute Values and Change From Baseline of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Scores
Time Frame
Baseline, Weeks 12, 24, 36, 48 and 52
Title
Absolute Values and Change From Baseline of CDASI Damage Score
Time Frame
Baseline, Weeks 12, 24, 36, 48 and 52
Title
Total Improvement Score (TIS) at Week 52 and at intermediate scheduled timepoints for participants who entered from stage 3 of protocol C0251002
Time Frame
Week 52
Title
Change Over Time In the Physician Global Assessment (PhGA)
Description
Clinical assessment completed by the physician of the overall disease status
Time Frame
Week 52
Title
Change over time in the Patient Global Assessment PtGA
Description
Clinical assessment completed by the study participant of their overall disease status
Time Frame
Week 52
Title
Change over time in the Manual Muscle Testing 8 groups (MMT-8)
Description
Clinical assessment of muscle disease
Time Frame
Week 52
Title
Change Over Time In the Health Assessment Quality of Life and Disability Index (HAQ-DI)
Description
Patient reported outcome on how the study participant rate their health assessment and quality of life and disability
Time Frame
Week 52
Title
Change in Muscle Enzyme Laboratory Values Over Time
Description
For muscle enzymes, the most abnormal serum muscle enzyme level at baseline (creatine kinase, aldolase, alanine transaminase, aspartate aminotransferase, lactate dehydrogenase) is used
Time Frame
Week 52
Title
Change Over Time In the Myositis Disease Activity Assessment Tool
Description
Clinical assessment completed by the physician to measure the myositis activity
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham, Department of Dermatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Attune Health Research Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
KU Clinical and Translational Science Unit (CTSU) Rainbow
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital - CTH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Grossman School of Medicine, The Ronald O. Perelman Department of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Health Clinical Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Radiology - Ambulatory Care Center East 41st Street
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Mount Sinai Doctors Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Center for Human Phenomic Science
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania, Perelman Center for Advanced Medicine (PCAM)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Nova Reuma Społka Partnerska
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-707
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C0251008
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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