A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris
Condition: Pityriasis Rubra Pilaris
MeSH terms: Pityriasis; Dermatitis, Exfoliative; Pityriasis Rubra Pilaris
Intervention: Alefacept
Intervention description: 15mg intramuscular injection weekly for 12 weeks
Intervention MeSH terms: Alefacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: PRP; Pityriasis Rubra Pilaris; Amevive; Alefacept; Biologic; Immunosuppressant; Severe skin disease

Summary:

      The purpose of this study is to determine whether the biologic medication alefacept (Amevive)
      is effective and safe in the treatment of Pityriasis Rubra Pilaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects may be male or female, 30 years old or older at time of consent

          -  Have a diagnosis of pityriasis rubra pilaris at least 6 months prior to administration
             of the first dose of the study medication

          -  Be a candidate for systemic therapy

          -  Women of childbearing potential and all men must use adequate contraceptive measures
             if sexually active. Examples include abstinence, oral contraceptives or other form of
             hormonal contraception, intrauterine devices, surgical sterilization, or barrier forms
             of contraception with spermicidal jelly. Subjects must agree to continue to use these
             contraceptive measures and agree not to become or plan a pregnancy within 12 months of
             the date of the last study drug administration.

          -  Agree to adhere to the study visit schedule and protocol requirements, including blood
             draws and clinical photographs.

          -  Must be able to give informed consent, and this consent must be obtained prior to any
             study related procedures being performed.

          -  Must avoid other treatment modalities during the course of the study and adhere to
             standard washout periods for any medications used to treat their skin prior to
             receiving the first dose of study medication.

          -  Must agree not to receive a live viral or bacterial vaccine during the course of the
             study or for 12 months after the date of the last study drug administration.

          -  Have screening blood tests that are stable as deemed by the physician investigator.
             AST, ALT and alkaline phosphatase levels must be within 2.0 times the upper limit of
             normal to participate.

        Exclusion Criteria:

          -  Subjects are pregnant or planning a pregnancy (both men and women) while enrolled in
             the study.

          -  Have used the medication alefacept in the past.

          -  Have used another investigational medication within the past 4 weeks or within 5 times
             the half-life of that investigational medicine.

          -  Have received systemic medications that could affect pityriasis rubra pilaris within 4
             weeks of administration of the first dose of the study medicine.

          -  Have used topical medications that could affect pityriasis rubra pilaris within 2
             weeks of administration of the first dose of the study medicine.

          -  Have received a live viral or bacterial vaccine within 3 months of administration of
             the first dose of the study medicine.

          -  Have a history of chronic or recurrent infections of the skin or internal organs.

          -  Have had a serious infection requiring hospitalization or intravenous antibiotics
             within 2 weeks of administration of the first dose of the study medicine.

          -  Have a history of latent untreated tuberculosis.

          -  Have a known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
             virus.

          -  Have a history of a malignancy except for squamous cell or basal cell carcinoma of the
             skin or cervical carcinoma in situ that has been treated with no evidence of
             recurrence.

          -  Have a known hypersensitivity to any component of alefacept.

          -  Have a known substance abuse problem or is deemed by the investigator as unable to
             follow the study protocol.

          -  Is participating in another study for an investigational agent or procedure during the
             course of this study.