An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Apremilast for the Treatment of Nail Psoriasis
Condition: Psoriatic Nail; Psoriasis Vulgaris; Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Psoriasis vulgaris is a common inflammatory condition of the skin that results in scaly red
      itchy plaques. In addition to affecting the skin, psoriasis can also cause disease in the
      finger and toe nails. The most characteristic nail findings associated with nail psoriasis
      are nail pitting, onycholysis with a rim of erythema, and oil spots. Because nail psoriasis
      causes a substantial disease burden for patients, it is critical that safe and effective
      treatments are found for this specific type of psoriasis. Unfortunately, nail psoriasis is
      often difficult to treat.

      Apremilast is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4) that
      is FDA approved for the treatment of psoriasis and psoriatic arthritis. Apremilast has shown
      promising results for treating psoriatic arthritis and nail disease; however more data is
      needed regarding its effect on nail psoriasis (Kavanaugh, et al). We hypothesize that
      apremilast will prove to be highly effective in treating nail psoriasis. We propose to
      conduct an open label clinical trial to investigate the efficacy and tolerability of
      apremilast in treating nail psoriasis, where we will follow the package insert guidelines for
      treating patients with apremilast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Patients older than 18

          -  Give written informed consent prior to any study procedures being conducted, and
             candidates will authorize the release and use of protected health information (PHI)

          -  Be willing and consent to having photos taken of their fingernails

          -  Diagnosis of chronic plaque psoriasis that has been present for at least 6 months
             prior to baseline

          -  Plaque psoriasis involving at least 5% of the patient's body surface area

          -  Nail psoriasis in at least one finger nail with a mNAPSI of 5 or greater

          -  A Nail Pain VAS score of 4 or higher. The Nail Pain VAS will assess the severity of
             pain linked to the nail disease.

          -  Must have discontinued all systemic therapies for the treatment of psoriasis or
             psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics 2 months or 5
             half-lives (whichever is longer) prior to baseline visit

          -  Must have discontinued all topical therapies for the treatment of psoriasis at least 2
             weeks prior to baseline visit

          -  Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA
             (psoralen ultraviolet light therapy) at least 4 weeks prior to baseline.

          -  Subjects must be in good general health without significant uncontrolled
             comorbidities, other than psoriasis, as determined by the investigator based on exam
             findings, medical history, and clinical laboratories. Patients with stable mild renal
             insufficiency are eligible for enrolling in this trial.

          -  Females of childbearing potential must use an approved birth control method while
             receiving treatment and for 28 days following the last dose of apremilast, and there
             must be a documented negative pregnancy tests prior to initiating treatment. Approved
             birth control methods include hormonal contraception (oral, injection, implant,
             transdermal patch, vaginal ring), intrauterine device, partners vasectomy, or male or
             female condoms that are not made of natural materials plus a diaphragm with
             spermicide, cervical cap with spermicide, or a contraceptive sponge with spermicide.
             Females not of child bearing potential are defined as being at least 1 year
             postmenopausal or surgically sterile (bilateral tubal ligation, bilateral oophorectomy
             and/or hysterectomy).

          -  Male subjects, including those who have had a vasectomy, must use condoms not made of
             natural materials for the duration of the trial and for at least 28 days after the
             last dose of apremilast if conception is possible.

        Exclusion Criteria:

          -  - Unable to comply with the protocol (as defined by the Investigator; i.e. drug or
             alcohol abuse or history of noncompliance)

          -  Pregnancy or breastfeeding

          -  Female patients of childbearing potential and male patients who engage in activity
             where contraception is possible who are unable to use the approved methods of
             contraception throughout the length of the study and 28 days following the last dose

          -  Patients who have or have had thoughts of suicide or hurting themselves.

          -  Patients with prior exposure to apremilast

          -  Subject has been treated with an investigational drug within 30 days or 5 half-lives
             (whichever is longer) prior to baseline visit.

          -  Patients with severe, progressive, or uncontrolled medical or psychiatric disease.

          -  Concomitant therapy with medications that are strong cytochrome P450 inducers,
             including rifampin, phenobarbital, carbamazepine, or phenytoin

          -  Any other dermatologic conditions that prohibit or confound the ability of the
             investigator to interpret skin and/or nail exam findings.

          -  Patients who will be unable to avoid the use of systemic steroids, excluding
             intranasal or inhaled steroids that will be permitted, for the duration of the trial

          -  Any known hypersensitivity to apremilast

          -  Any subject who, in the opinion of the investigator, will be uncooperative or unable
             to comply with duty procedures