An Open Label Study Evaluating the Safety and Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Dermatomyositis

This study is designed to evaluate the safety and efficacy of an oral medicine (called apremilast) for treating skin involvement in patients with the disease dermatomyositis.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Intervention(s):

  • drug : Apremilast

Phase: N/A

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Must understand and voluntarily sign an informed consent form - Must be 18 years at time of signing informed consent form - Must be able to adhere to the study visit schedule and other protocol requirements - Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer1 and a skin biopsy consistent with DM - Subjects must be a candidate for systemic therapy for their DM skin disease: a subject is considered a candidate, if, in the judgment of the investigator, they are not adequately responding to aggressive sun protection along with the use of potent (e.g. class I or II) topical corticosteroids and/or immunomodulators - Must have cutaneous disease activity of at least "moderate" on a 5 point Likert scale (using the PGA) - Must have cutaneous disease activity score of at least 5 on the CDASI (activity) scale - Concurrent therapy with topical corticosteroids and/or prednisone and/or antimalarials is permitted as defined in Exclusion Criteria. - Concurrent therapy with methotrexate azathioprine, mycophenolate mofetil, or leflunomide is permitted as defined in Exclusion Criteria - Must meet the following laboratory criteria: - Hemoglobin &#8805; 12 g/dL - White blood cell (WBC) count &#8805; 3000 /uL (&#8805; 3.0 X 10^9/L) and < 14,000/uL (< 14 X 10^9/L) - Platelets &#8805; 100,000 /uL (&#8805; 100 X 10^9/L) - Serum creatinine &#8804; 1.5 mg/dL (&#8804; 132.6 &#956;mol/L) - Total bilirubin &#8804; 2.0 mg/dL - Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ; 1.5x upper limit of normal (ULN) unless, in the opinion, of the investigator, the elevation is secondary to active muscle inflammation. - Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner. A FCBP must agree to have pregnancy tests every 28 days while on study medication. - Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

External Links

Contact information

Primary Contact:

Katharine Arefiev, MD 650-723-6316

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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