Pyoderma GangrenosumPhase 2NCT01302795
Canakinumab for Pyoderma Gangrenosum
A Phase 2 study testing Canakinumab in people with Pyoderma Gangrenosum, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Canakinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Zurich
Zurich, 8091
About this study
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
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.
Read the detailed description
At the start of the study (week 0), all patients will receive one subcutaneous injection of 150mg Canakinumab. Patients are then going to be examined at weeks 2, 4, 8, 12 and 16.
At 2 weeks, all patients are going to be evaluated for response by Physician's global assessment (PGA) of the target lesion. Patients with PGA 0-1 are not going to receive another injection at this timepoint, while patients with PGA 2-4 are going to receive another 150mg Canakinumab.
At 4 weeks, in case of PGA 4, patients are going to be offered a first or second line drug as an alternative therapy (corticosteroids, cyclosporin A or infliximab, dosage see below "Alternative therapy in case of missing response") and stay within the trial (due to the long half-life of canakinumab) until week 8.
At week 8, patients with PGA 0 receive another 150mg Canakinumab only, and patients with PGA 4 are not going to receive additional study drug, but are strongly encouraged to attend following medical visits for observation until the end of the study and/or switch to a first or second line drug as alternative therapy (see below). All other patients with PGA 1-3 receive the total accumulative dose of Canakinumab that they had received on week 0 and 2, namely 150 or 300mg.
The study duration for each individual is going to be 16 weeks. At week 8 and 16, safety laboratory investigations with blood differential (Neutrophil granulocytes, monocytes, eosinophils, basophils, lymphocytes, thrombocytes, erythrocytes, hemoglobin), AST, ALT, y-GT, AP, Bilirubin (total), Creatinine, Na, K, CRP are going to be determined.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Canakinumab
- Keywords
- Interleukin 1 beta, Canakinumab, autoinflammatory syndrome
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called Ilaris
Monoclonal antibody inhibiting interleukin 1 beta
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab | Experimental | Canakinumab s.c. 150-300mg Week 0, (2), 8 Receives: Drug: Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 2, 4, 8, 16
Secondary outcomes (2)
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.
Measured: Week 2, 4, 8, 16
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.
Measured: Week 2, 4, 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars French, Prof MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302795
- Sponsor's protocol ID
- DER-USZ-AAN-008
- Status last verified
- Sep 2016
- First submitted
- 17 Feb 2011
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data are in the Publication Kolios et al. British Journal of Dermatology, 2015
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01302795
- Acronym / sponsor ID
- DER-USZ-AAN-008
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Interleukin 1 beta, Canakinumab, autoinflammatory syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective open label evaluation of Canakinumab (Ilaris) for treatment of subjects with pyoderma gangrenosum.
Detailed description
At the start of the study (week 0), all patients will receive one subcutaneous injection of 150mg Canakinumab. Patients are then going to be examined at weeks 2, 4, 8, 12 and 16.
At 2 weeks, all patients are going to be evaluated for response by Physician's global assessment (PGA) of the target lesion. Patients with PGA 0-1 are not going to receive another injection at this timepoint, while patients with PGA 2-4 are going to receive another 150mg Canakinumab.
At 4 weeks, in case of PGA 4, patients are going to be offered a first or second line drug as an alternative therapy (corticosteroids, cyclosporin A or infliximab, dosage see below "Alternative therapy in case of missing response") and stay within the trial (due to the long half-life of canakinumab) until week 8.
At week 8, patients with PGA 0 receive another 150mg Canakinumab only, and patients with PGA 4 are not going to receive additional study drug, but are strongly encouraged to attend following medical visits for observation until the end of the study and/or switch to a first or second line drug as alternative therapy (see below). All other patients with PGA 1-3 receive the total accumulative dose of Canakinumab that they had received on week 0 and 2, namely 150 or 300mg.
The study duration for each individual is going to be 16 weeks. At week 8 and 16, safety laboratory investigations with blood differential (Neutrophil granulocytes, monocytes, eosinophils, basophils, lymphocytes, thrombocytes, erythrocytes, hemoglobin), AST, ALT, y-GT, AP, Bilirubin (total), Creatinine, Na, K, CRP are going to be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canakinumab | Experimental | Drug: CanakinumabCanakinumab s.c. 150-300mg Week 0, (2), 8 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: IlarisMonoclonal antibody inhibiting interleukin 1 beta | Drug | Canakinumab |
Primary outcome
Change of the Physician's global assessment (Grade 0-4) of the target lesion
Time frame: Week 2, 4, 8, 16
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Yes. The data are in the Publication Kolios et al. British Journal of Dermatology, 2015
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars French, Prof MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab in people with Pyoderma Gangrenosum, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Physician's global assessment (Grade 0-4) of the target lesion (time frame: Week 2, 4, 8, 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.