An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
Condition: Pyoderma Gangrenosum
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Intervention: Ixekizumab
Intervention description: Injection
Intervention MeSH terms: Ixekizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major inclusion criteria:

          -  Have a clinical diagnosis of classic Pyoderma Gangrenosum for at least 3 months as
             determined by the investigator and an external reviewer on the basis of results from
             clinical, histological and laboratory assessments

          -  At screening, have a Pyoderma Gangrenosum ulcer characterized by 'item a' AND 3/5
             features in 'item b' OR 2/5 features in 'item b' with support from one of the
             conditions listed in c.

             a. Stable or increasing size within 2 months preceding screening by patient report or
             documentation b. Features such as violaceous border, undermining, d. Intralesional
             corticosteroids within 8 weeks of day 0; topical immunomodulators are permitted.

             e. Wound debridement within 2 weeks of Day 0; dressing changes allowed per
             investigator discretion.

             g. Systemic antibiotics within 2 weeks of Day 0 h. Live, attenuated vaccines within 3
             months of Day 0; or live, seasonal-flu- or H1N1 vaccines within 2 weeks of Day 0.
             Note: recombinant- and/or killed vaccines are permitted.

             i. Hyperbaric treatment within 4 weeks of Day 0 j. Investigational drug or
             investigational device within 30 days or 5 half-lives of Day 0, whichever is longer k.
             Prior exposure to ixekizumab l. Other treatments not described above should be
             maintained at a stable dose and frequency throughout the study as best as possible 13.
             Major, general surgery within 3 months of screening, or anticipated general surgery
             during the study period 14. Pregnancy, plans to become pregnant during the course of
             the study, delivery within 3 months of screening, or breast-feeding 15. If previous
             use of cyclosporine or systemic corticosteroids, failure to have any
             stabilization/response is exclusionary. This potentially indicates the disease is not
             Pyoderma Gangrenosum.

        Exclusion Criteria:

          -  Major exclusion criteria:

               1. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or
                  situation that may compromise the ability of the subject to give written informed
                  consent, may put the subject at significant risk, may jeopardize the subject's
                  safety after exposure to the study drug, may confound the study results, or may
                  interfere significantly with the subject's participation in the study

               2. History of malignancy within 2 years of screening other than carcinoma in situ of
                  the cervix or adequately treated, non-metastatic, squamous or basal cell
                  carcinoma of the skin

               3. History of seropositivity for HIV antibody; active or carrier status of hepatitis
                  B [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with
                  negative surface antibody]; active hepatitis C (i.e. not treated or not cleared
                  spontaneously, as confirmed by HCV PCR)

               4. History of severe allergic or anaphylactic reaction to monoclonal antibodies

               5. Systemic infection (excluding wound colonization) requiring oral antibiotics
                  within 2 weeks of Day 0

               6. History of the following treatments:

                    1. Anti-Tumor Necrosis Factor or other biologic therapies within 5 half-lives
                       of screening

                    2. Changes (addition, discontinuation, or changes in dose) in immunosuppressive
                       medication (including cyclosporine, azathioprine, methotrexate,
                       mycophenolate mofetil, apremilast, dapsone, or corticosteroids) within 2
                       months of Day 0

                    3. Systemic corticosteroids > 20 mg per day (prednisone or prednisone
                       equivalent) within 8 weeks of Day 0, or change in dose within 8 weeks of Day
                       0. Steroids may be tapered (although not increased above the Day 0 dose)
                       during the trial as determined by the investigator.

        they are prescribed at stable doses for two months prior to baseline and are 20 mg or less
        per day of prednisone or other equivalently-dosed corticosteroids.

        4. Intralesional corticosteroids within 4 weeks of screening and during the study are not
        permitted 5. Other therapies that are non-immunosuppressive and non-investigational can be
        started or continued at physician discretion provided the medicine has no history of
        association with progressive multifocal leukoencephalopathy. Antibiotics may be used as
        needed for evidence of superinfection, positive culture results, malodor, green discharge,
        etc.