A Study In Adults With Moderate To Severe Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: PF-06823859 low; Placebo Arm; PF-06823859 high
Intervention description: A humanized immunoglobulin neutralizing antibody; Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid; A humanized immunoglobulin neutralizing antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria for Patients with Skin Predominant Activity:

          -  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 8 biopsies during the course of the research study

        Inclusion Criteria for Patients with Muscle Predominant Activity:

          -  MMT-8 ≤136/150 and PhGA, VAS ≥3 cm (0-10 cm) by visual analog scale (VAS)

          -  Sum of PhGA, VAS, PtGA, and extramuscular global assessment VAS scores is ≥10 cm (0-10
             cm) VAS for each.

               -  Participant has failed at least two or more adequate courses of an
                  immunosuppressive agent or immunomodulatory agent, including IVIG, at a dose
                  known to be effective for rheumatologic diseases.

        Exclusion Criteria for Patients with Skin Predominant Activity:

          -  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

        Exclusion Criteria for Patients with Muscle Predominant Activity:

        Similar to patients with skin predominant activity; Intake of >20 mg oral prednisone/day,
        or equivalent