A Study to Evaluate the Effectiveness, Safety and Tolerability of PF-06823859 In Adults With Moderate-to-Severe Dermatomyositis

Overview

About this study

The purpose of this study is to evaluate the investigational drug PF-06823859 and a placebo administered to adult pPatients with moderate-to- severe Dermatomyositis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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, (e.g., 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Laura Akhtar CCRP

Akhtar.Laura@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20461643

Mayo Clinic Footer