Purpose

A Study looking at Investigational drug and Placebo administered to adult Patients with moderate to severe Dermatomyositis

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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:
  • Gottron's papules;
  • Gottron's sign;
  • Heliotrope eruption;
  • Nailfold changes, (dilated capillary loops, capillary dropout, cuticular hypertrophy and/or rugged cuticles;
  • Photodistributed violaceous erythema, (skin that is exposed to sunlight and appears purplish/reddish, and patchy in appearance;
  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo ARM
  • Drug: Placebo Arm
    Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid
Experimental
PF-06823859 Arm
  • Drug: PF-06823859
    A humanized immunoglobulin neutralizing antibody

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233

UAB Hospital, IDS Pharmacy
Birmingham, Alabama 35249

More Details

NCT ID
NCT03181893
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.