A PHASE 2A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY SAFETY AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Other Dermatomyositis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are between the ages of 18 and 80 years of age
    2. Subjects able to complete and sign the written consent form and comply with requirements of protocol
    3. Subjects with cutaneous Dermatomyositis Disease Area and Severity Index Activity Score, (CDASI) v2-a Activity =14, and have failed at least 1 standard of care systemic treatment
    4. Subjects diagnosed with Dermatomyositis by the investigator and symptoms as per the protocol
    5. Subjects are willing to provide at least 6 skin biopsies
    6. Women of childbearing potential (WOCBP) and men able to father a child must be ready to use 2 highly effective methods of birth control throughout the duration of the study, including the follow-up period until the end of study.

You may not be eligible for this study if the following are true:

  • Subjects with other acute or chronic medical or psychiatric condition including recent or active suicidal ideation or behavior or laboratory abnormality that would make the subject inappropriate for entry into this study
  • Subjects with any psychiatric condition that meets the criteria listed in the protocol
  • Subjects who had intake of >15 mg oral prednisone/day, or equivalent.
  • Subjects with drug induced myopathy, metabolic myopathy, dystrophy, cancer associated DM, mixed connective tissue disease-associated DM
  • Significant concurrent disease or conditions other than DM that may influence response to the study drug or safety.
  • Subjects with abnormal labs as per the protocol
  • Subjects participation in other studies involving investigational drug(s) within 30 days prior to study entry.
  • Subjects who are pregnant or lactating
  • Subjects who received the following within 180 days of Day 1:
    • A biologic investigational agent
    • IV or oral cyclophosphamide, belimumab or any anti-B-Lymphocyte Stimulator
    • Required 3 or more courses of systemic corticosteroids for concomitant conditions
  • Subjects who received the following within 90 days of Day 1:
    • Anti-TNF therapy
    • High dose oral corticosteroids (>100 mg/day prednisone or equivalent) or pulse IV doses
    • Plasmapheresis
  • Subjects who received the following within 60 days of Day 1:
    • Any intra muscular (IM) or IV steroid injection
    • Tofacitinib or any other Janus kinase (JAK) inhibitors
    • Any change in dose of an immunosuppressive/immunomodulatory or antimalarial agent. Dose must be stable for 60 days prior to Day 1 and remain stable through Week 12.
    • Inhaled immunosuppressive agents
    • Disease-modifying antirheumatic drugs
    • Subjects may be on one of the following cytotoxic agents: methotrexate, azathioprine, leflunomide, mycophenolate, or 6 MP, but not on any combination of these cytotoxic agents.
    • Use of IV or IM antibacterials, antivirals, antifungals, or anti-parasitic agents within 60 days of Day 1
  • Subjects who received the following within 6 weeks of Day 1:
    • A live (live attenuated) vaccine
  • Subjects who received the following within 30 days of Day 1:
    • Any intra-articular steroid injection.
    • Any new, or change in dose of a corticosteroid or equivalent.
    • Any new, or change in dose of intravenous immunoglobulin (IVIG)
  • Subjects who received the following within 14 days prior of Day 1:
    • Stable dose of topical immunosuppressants of any strength used on the scalp is permitted throughout the study
  • Subjects who have been treated with any B-cell depleting agents such as rituximab
  • Subjects with a history of a major organ transplant
  • Subjects with active bacterial, viral, fungal, mycobacterial or other infections
  • Subjects with clinically significant finding on a chest radiograph
  • Subjects infected with Mycobacterium tuberculosis
  • Subjecy with a history of any lymphoproliferative disorder
  • Subjects with known history of the HIV, positive test for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBcAb; also called anti-HBc), hepatitis B surface antibody (HBsAb), and/or HCV Ab as well as being screend for HBsAg and HBcAb
  • Subjects with required management of acute or chronic infections
  • Subjects who have acute coronary syndrome
  • Subjects with cancer or a history of cancer within 5 years
  • Subjects with pre-existing demyelinating disorder
  • Subjects with current alcohol and/or drug abuse
  • Subjects with had major surgery within 4 weeks of screening, or scheduled to occur during the study
  • Subjects with previous treatment with total lymphoid irradiation
  • Subjects with Grade 3 or greater laboratory abnormality



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