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A Study In Adults With Moderate To Severe Dermatomyositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181893
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE January 23, 2018
Estimated Primary Completion Date April 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
CDASI Activity Score [ Time Frame: Change from baseline activitly, (DAY 1) score at week 12 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • CDASI Activity Scores [ Time Frame: Baseline, (DAY 1) - week 12 ]
    Absolute values and change from baseline CDASI activity score through week 12
  • CDASI Damage score [ Time Frame: Baseline, (DAY 1)-week 12 ]
    Absolute values and change from baseline CDASI Damage Score through week 12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study In Adults With Moderate To Severe Dermatomyositis
Official Title  ICMJE A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS
Brief Summary A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatomyositis
Intervention  ICMJE
  • Drug: PF-06823859 low
    A humanized immunoglobulin neutralizing antibody
  • Drug: Placebo Arm
    Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid
  • Drug: PF-06823859 high
    A humanized immunoglobulin neutralizing antibody
Study Arms  ICMJE
  • Placebo Comparator: Placebo ARM
    Intervention: Drug: Placebo Arm
  • Experimental: PF-06823859 ARM high
    Intervention: Drug: PF-06823859 high
  • Experimental: PF-06823859 ARM low
    Intervention: Drug: PF-06823859 low
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 21, 2022
Estimated Primary Completion Date April 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must have CDASI Activity score of greater than or equal to 14, and have failed at least 1 standard of care systemic treatment, (eg, corticosteroids).
  • Confirmation of DM by the investigator and two of the following:

    1. Gottron's papules;
    2. Gottron's sign;
    3. Heliotrope eruption;
    4. Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
    5. Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
    6. Positive DM serology -
  • Post DM diagnosis; standard of care workup for DM must have been completed prior to entry into this research study.
  • Willing to provide 6 biopsies during the course of the research study

Exclusion Criteria:

  • Investigator site staff or members of their family.
  • Acute and Chronic present medical conditions
  • Intake of greater than 15 mg of prednisone or equivalent per day
  • Pregnant or breastfeeding females. Fertile men and women who will not comply with the use of 2 effective birth control methods as per the research protocol
  • Have required management of acute or chronic infections
  • Have pre existing demyelinating disorder such as multiple sclerosis, or other severe neurological deficits.
  • Clinically significant lab abnormalities
  • Any health condition that may be worsened by immunosuppression
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181893
Other Study ID Numbers  ICMJE C0251002
2020-004228-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP