Canakinumab for Pyoderma Gangrenosum

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT01302795
• Date of registration: 17/02/2011
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Canakinumab for Pyoderma Gangrenosum
• Scientific 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
• Date of first enrolment: February 2011
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01302795
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Lars French, Prof MD
• Affiliation: University Hospital Zurich, Division of Dermatology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pyoderma Gangrenosum

Intervention(s)

Drug: Canakinumab

Primary Outcome(s)

Change of the Physician's global assessment (Grade 0-4) of the target lesion [Time Frame: Week 2, 4, 8, 16]

Secondary Outcome(s)

Change in surface area of the target lesion of pyoderma gangrenosum [Time Frame: Week 2, 4, 8, 16]

Change in surface area of the non-target lesions [Time Frame: Week 2, 4, 8, 16]

Secondary ID(s)

DER-USZ-AAN-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors