Canakinumab for Pyoderma Gangrenosum

NCT01302795 | Completed Phase 2 DMC

• 1 other identifier: DER-USZ-AAN-008
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pyoderma Gangrenosum

Keywords

Interleukin 1 beta; Canakinumab; autoinflammatory syndrome

Outcome Measures

Primary Outcomes (1)

• 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 1. Almost completely healed target ulcer with only minimal signs of active PG 2. Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3. Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin 4. No evidence of target healing ulcer

  Week 2, 4, 8, 16

Secondary Outcomes (2)

• Change in surface area of the target lesion of pyoderma gangrenosum

  Week 2, 4, 8, 16

• Change in surface area of the non-target lesions

  Week 2, 4, 8, 16

Study Arms (1)

Canakinumab

EXPERIMENTAL

Canakinumab s.c. 150-300mg Week 0, (2), 8

Drug: Canakinumab

Interventions

Canakinumab DRUG

Monoclonal antibody inhibiting interleukin 1 beta

Also known as: Ilaris

Canakinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age = 18 years of age at visit 0 and
• Subjects are capable of giving informed consent
• Non-healing ulcer with primarily neutrophil infiltration, regardless of size and location

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Dermatology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Study Officials

• Lars French, Prof MD

  University Hospital Zurich, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2015
• Last Updated: September 27, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)