Pyoderma GangrenosumPhase 2NCT01965613
A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
A Phase 2 study testing Xilonix in people with Pyoderma Gangrenosum, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Xilonix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2014to 31 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18
- History of pyoderma gangrenosum with or without other systemic disease.
Who cannot join
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Treatment with corticosteroids or cyclosporine within the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
XBiotech Investigative Site
Tallahassee, Florida, 32308
About this study
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.
Read the detailed description
XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Xilonix
- Keywords
- Pyoderma Gangrenosum
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XilonixBiological
IV
| Study group | Role | What they receive |
|---|---|---|
| open label-Xilonix | Experimental | Open label-Xilonix Receives: Biological: Xilonix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physician's Wound Assessment & Patient's Global Assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study start31 Jan 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965613
- Sponsor's protocol ID
- 2013-PT025
- Status last verified
- Jul 2025
- First submitted
- 15 Oct 2013
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT01965613
- Acronym / sponsor ID
- 2013-PT025
- Conditions
- Pyoderma Gangrenosum
- Keywords
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Oct 2013 (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.
The purpose of this study is to determine if treatment with Xionix will improve wound healing for patients with pyoderma gangrenosum.
Detailed description
XBiotech owned bermekimab and sponsored and completed study prior to Dec 30, 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label-Xilonix | Experimental | Biological: XilonixOpen label-Xilonix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: ≥18
- History of pyoderma gangrenosum with or without other systemic disease.
Key exclusion criteria (2 listed)
- Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Treatment with corticosteroids or cyclosporine within the last 2 weeks.
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 |
|---|---|---|
| XilonixIV | Biological | open label-Xilonix |
Primary outcome
Change in Physician's Wound Assessment & Patient's Global Assessment
Time frame: 28 days
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 8 Jul 2025.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Xilonix in people with Pyoderma Gangrenosum, run by Janssen Research & Development, LLC at 1 site in United States.
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 2 inclusion and 2 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 8 Jul 2025. 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 United States. 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 in Physician's Wound Assessment & Patient's Global Assessment (time frame: 28 days). 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 8 Jul 2025.