Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
Condition: Pityriasis Rubra Pilaris
MeSH terms: Pityriasis; Dermatitis, Exfoliative; Pityriasis Rubra Pilaris
Intervention: Ixekizumab
Intervention description: Treatment at the FDA-approved psoriasis dosing
Intervention MeSH terms: Ixekizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ixekizumab; IL-17; Pityriasis Rubra Pilaris (PRP)

Summary:

      15 patients with PRP will be treated with ixekizumab for 24 weeks to determine safety and
      efficacy. Participants are required to travel to Portland, OR only for the first visit and
      week-24 visit. 5 visits in between these times and one follow up visit may be performed by
      secure videoconferencing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of PRP by clinical assessment and biopsy.

          -  Male subject age 18-99.

          -  Female subject age 18-99; either of non-childbearing potential or of childbearing
             potential who test negative for pregnancy and agree to use a reliable method of birth
             control or remain abstinent during the study and for at least 12 weeks following the
             last dose of ixekizumab.

          -  PASI score of 10 or greater at baseline.

          -  Are a candidate for phototherapy and/or systemic therapy.

          -  Willingness to travel to OHSU for all study visits, OR living >30 miles from OHSU and
             willing/able to participate in remote videoconferencing visits with access to a
             computer with internet capabilities and webcam.

          -  Have given written informed consent approved by the OHSU Investigational Review Board.

        Exclusion Criteria:

          -  Known malignancy or lymphoproliferative disease (except treated basal cell skin
             cancer, treated squamous cell skin cancer, or treated cervical carcinoma in situ) for
             at least 5 years.

          -  Active, untreated, acute or chronic infection (such as untreated tuberculosis), or
             immunocompromised to an extent that such that participation in the study would pose an
             unacceptable risk to the subject. (Treated infections such as latent tuberculosis
             after completion of the appropriate therapy are not excluded.)

          -  Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.

          -  Previous treatment with any agent that targets interleukins 17 specifically.

          -  Systemic treatment or phototherapy for PRP within the past 4 weeks or 5 half-lives
             prior to baseline, whichever is longer. For biologic therapies, the specific washout
             periods used will be: etanercept <28 days; infliximab, adalimumab, or alefacept <60
             days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months.

          -  Have a known allergy or hypersensitivity to any biologic therapy that would pose an
             unacceptable risk to the subject if participating in this study.

          -  Have a live vaccine within 12 weeks prior to baseline or intend to have a live vaccine
             during the course of study.

          -  Had any major surgery within 8 weeks prior to baseline or will require major surgery
             during the study that, in the opinion of the investigator, would pose an unacceptable
             risk to the subject.

          -  Presence of significant uncontrolled cerebrovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders,
             or abnormal laboratory screening values that, in the opinion of the investigator, pose
             an unacceptable risk to the subject if participating in the study or of interfering
             with the interpretation of the data.

          -  Presence of inflammatory bowel disease

          -  Have clinical laboratory test results at screening that are outside the normal
             reference range of the population and are considered clinically significant, or have
             any of the following specific abnormalities: Neutrophil count <1500 cells/µL,
             lymphocyte count <500 cells/µL, platelet count <100,000 cells/µL, AST or ALT > 2.5
             times the upper limit of normal, hemoglobin <8.5 g/dL for male subjects and <8.0 g/dL
             for female subjects, serum creatinine >2.0 mg/dL.

          -  Women who are lactating or breastfeeding.

          -  Have any other condition that precludes the subject from following and completing the
             protocol, in the opinion of the investigator.

          -  Are investigator site personnel directly affiliated with this study and/or their
             immediate families (spouse, parent, child, or sibling).

        Are currently enrolled in, or discontinued from a clinical trial involving an
        investigational product or non-approved use of a drug or device within the last 4 weeks or
        a period of at least 5 half-lives of the last administration of the drug, whichever is
        longer, or concurrently enrolled in any other type of medical research judged not to be
        scientifically or medically compatible with this study.