Pyoderma Gangrenosum Clinical Trial
Official title:
A Phase II Multi Center Open Label Pilot Study To Assess a Potential Effect of an Anti-Il-1-Beta Antagonist in the Treatment of Pyoderma Gangrenosum
Verified date | September 2016 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.
Status | Completed |
Enrollment | 5 |
Est. completion date | November 2015 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Dermatology, University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the Physician's global assessment (Grade 0-4) of the target lesion | The primary response parameter change of the physician global assessment (PGA) 5-point scale at week 2, 4, 8, 16 as compared to week 0 : 0= Total resolution of target ulcer with no signs of active PG Almost completely healed target ulcer with only minimal signs of active PG Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin No evidence of target healing ulcer |
Week 2, 4, 8, 16 | No |
Secondary | Change in surface area of the target lesion of pyoderma gangrenosum | As secondary parameter, the change in surface area of the target lesion of pyoderma gangrenosum at week 2, 4, 8, 16 as compared to week 0 will be assessed by measuring the two-dimensional surface by tracing the border of the lesions on transparent foil as well as with Canfield photography. | Week 2, 4, 8, 16 | No |
Secondary | Change in surface area of the non-target lesions | As secondary parameter, the change in surface area of the non-target lesions of pyoderma gangrenosum at week 2, 4, 8, 16 as compared to week 0 will be assessed by measuring the two-dimensional surface by tracing the border of the lesions on transparent foil as well as with Canfield photography. | Week 2, 4, 8, 16 | No |
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