Canakinumab for Pyoderma Gangrenosum

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion criteria: Patients fulfilling all of the following inclusion criteria may be enrolled in the study

1. Age = 18 years of age at visit 0 and

2. Subjects are capable of giving informed consent

3. Non-healing ulcer with primarily neutrophil infiltration, regardless of size and location

4. Diagnosis of pyoderma gangrenosum as confirmed by clinical and histological examination (see exclusion criteria). In case of doubt, a steering committee consisting of experts of the participating centers is going to evaluate whether inclusion is possible or not

Exclusion criteria:

• Other etiologies of ulcers 15, namely venous insufficiency, arterial occlusion, microcirculatory disorders, physical or chemical injury, infection, neuropathy, vasculitis, haematological disorders, neoplasia, other ulcerating diseases: Diseases with cutaneous manifestations mimicking pyoderma gangrenosum, including but not limited to Wegener's granulomatosis, polyarteritis nodosa, lymphoma, sporotrichosis and antiphospholipid syndrome.

• Classical systemic therapy (including but not limited to: corticosteroids, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, dapsone, cyclophosphamide) affecting pyoderma gangrenosum less than 14 days prior to enrollment.

• Therapy with other biologics (TNF antagonists, intravenous immunoglobulins) less than 3 months or 5 half-lives prior to enrollment, whichever is longer.

• Any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the baseline visit, whichever is longer. Washout period may be longer according to local requirements.

• Topical therapy affecting pyoderma gangrenosum for a period of 14 days prior to enrollment.

• Having a history of recurring bacterial, viral, fungal, atypical mycobacterial infection, especially active or latent granulomatous infections (incl. tuberculosis, histoplasmosis) or currently undergoing treatment for tuberculosis.

• A positive quantiferon test indicating possible latent tuberculosis infection.

• An abnormal chest x-ray indicating a possible infection or malignoma for a period of 3 months prior to enrollment.

• Known Human Immunodeficiency Virus (HIV)-, Hepatitis B (HBV)-, or Hepatitis C (HCV)-infection.

• Having a severe medical condition that, in the judgment of the investigator, would jeopardize in any way the subject's safety following exposure to study drug.

• Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study, lack of safe contraception.

Safe contraception is defined as follows:

Double-barrier contraception such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices together with condom use.

Both men and women must use safe contraception (double-barrier as defined above) during the duration of the study and until 6 months after the study.

Please note that female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.

• Having the presence or history of malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.

• Contraindications to monoclonal or polyclonal antibodies, e.g. known hypersensitivity or allergy to class of drugs or the investigational product.

• Known or suspected non-compliance, drug or alcohol abuse.

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.

• Participation in another treatment study within the 30 days preceding and during the present study.

• Previous enrollment into the current study.

• Enrollment of the investigator, his/her family members, employees and other dependent persons.