Pyoderma GangrenosumPhase 2NCT03137160
An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
A Phase 2 study testing Ixekizumab in people with Pyoderma Gangrenosum, run by Ohio State University at 1 site in United States.
Trial summary
An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- Ixekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to 16 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Major inclusion criteria:
- Have a clinical diagnosis of classic Pyoderma Gangrenosum for at least 3 months as determined by the investigator and an external reviewer on the basis of results from clinical, histological and laboratory assessments
- At screening, have a Pyoderma Gangrenosum ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c.
- Stable or increasing size within 2 months preceding screening by patient report or documentation b. Features such as violaceous border, undermining, d. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are permitted.
- Wound debridement within 2 weeks of Day 0; dressing changes allowed per investigator discretion.
- Systemic antibiotics within 2 weeks of Day 0 h. Live, attenuated vaccines within 3 months of Day 0; or live, seasonal-flu- or H1N1 vaccines within 2 weeks of Day 0. Note: recombinant- and/or killed vaccines are permitted.
- Hyperbaric treatment within 4 weeks of Day 0 j. Investigational drug or investigational device within 30 days or 5 half-lives of Day 0, whichever is longer k. Prior exposure to ixekizumab l. Other treatments not described above should be maintained at a stable dose and frequency throughout the study as best as possible 13. Major, general surgery within 3 months of screening, or anticipated general surgery during the study period 14. Pregnancy, plans to become pregnant during the course of the study, delivery within 3 months of screening, or breast-feeding 15. If previous use of cyclosporine or systemic corticosteroids, failure to have any stabilization/response is exclusionary. This potentially indicates the disease is not Pyoderma Gangrenosum.
Who cannot join
- Major exclusion criteria:
- Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may jeopardize the subject's safety after exposure to the study drug, may confound the study results, or may interfere significantly with the subject's participation in the study
- History of malignancy within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-metastatic, squamous or basal cell carcinoma of the skin
- History of seropositivity for HIV antibody; active or carrier status of hepatitis B [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody]; active hepatitis C (i.e. not treated or not cleared spontaneously, as confirmed by HCV PCR)
- History of severe allergic or anaphylactic reaction to monoclonal antibodies
- Systemic infection (excluding wound colonization) requiring oral antibiotics within 2 weeks of Day 0
Show all 12Show fewer
- History of the following treatments:
- Anti-Tumor Necrosis Factor or other biologic therapies within 5 half-lives of screening
- Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) within 2 months of Day 0
- Systemic corticosteroids > 20 mg per day (prednisone or prednisone equivalent) within 8 weeks of Day 0, or change in dose within 8 weeks of Day 0. Steroids may be tapered (although not increased above the Day 0 dose) during the trial as determined by the investigator.
- they are prescribed at stable doses for two months prior to baseline and are 20 mg or less per day of prednisone or other equivalently-dosed corticosteroids.
- 4. Intralesional corticosteroids within 4 weeks of screening and during the study are not permitted 5. Other therapies that are non-immunosuppressive and non-investigational can be started or continued at physician discretion provided the medicine has no history of association with progressive multifocal leukoencephalopathy. Antibiotics may be used as needed for evidence of superinfection, positive culture results, malodor, green discharge, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Dermatology
Gahanna, Ohio, 43230
About this study
An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
Read the detailed description
This is a Phase II study that will be open label and include a total of five patients who will receive the investigational product. These patients will have histological testing to rule out competing etiologies and require 3rd party adjudication/confirmation on agreement of the diagnosis. These patients will undergo 12 weeks of ixekizumab dosed every 2 weeks with follow-up until week 16.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- Ixekizumab
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxekizumabBiological
Also called Taltz
Injection
| Study group | Role | What they receive |
|---|---|---|
| Ixekizumab (Taltz) | Experimental | We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment. Receives: Biological: Ixekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12
The primary outcome will be the proportion of subjects achieving a 2-point reduction in the 5-point investigator global assessment for the target ulcer at Week 12. The measure type and unit of measure are the proportion of participants.
The IGA utilizes a 5 point Investigator Global Assessment measuring disease severity from 0- clear, 1-minimal, 2-mild, 3-moderate, 4- severe. 4 is the worst
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start4 May 2017
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Ben H Kaffenberger, Ohio State University
- Investigators
- Benjamin Kaffenberger, MD, Principal investigator, Dermatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137160
- Sponsor's protocol ID
- 2017H0045
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2017
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
- ClinicalTrials.gov ID
- NCT03137160
- Acronym / sponsor ID
- 2017H0045
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 4 May 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum
Detailed description
This is a Phase II study that will be open label and include a total of five patients who will receive the investigational product. These patients will have histological testing to rule out competing etiologies and require 3rd party adjudication/confirmation on agreement of the diagnosis. These patients will undergo 12 weeks of ixekizumab dosed every 2 weeks with follow-up until week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixekizumab (Taltz) | Experimental | Biological: IxekizumabWe have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major inclusion criteria:
- Have a clinical diagnosis of classic Pyoderma Gangrenosum for at least 3 months as determined by the investigator and an external reviewer on the basis of results from clinical, histological and laboratory assessments
- At screening, have a Pyoderma Gangrenosum ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c.
Key exclusion criteria (12 listed)
- Major exclusion criteria:
- they are prescribed at stable doses for two months prior to baseline and are 20 mg or less per day of prednisone or other equivalently-dosed corticosteroids.
- 4. Intralesional corticosteroids within 4 weeks of screening and during the study are not permitted 5. Other therapies that are non-immunosuppressive and non-investigational can be started or continued at physician discretion provided the medicine has no history of association with progressive multifocal leukoencephalopathy. Antibiotics may be used as needed for evidence of superinfection, positive culture results, malodor, green discharge, etc.
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 |
|---|---|---|
| IxekizumabAlso: TaltzInjection | Biological | Ixekizumab (Taltz) |
Primary outcome
The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12
Time frame: 12 Weeks
The primary outcome will be the proportion of subjects achieving a 2-point reduction in the 5-point investigator global assessment for the target ulcer at Week 12. The measure type and unit of measure are the proportion of participants. The IGA utilizes a 5 point Investigator Global Assessment measuring disease severity from 0- clear, 1-minimal, 2-mild, 3-moderate, 4- severe. 4 is the worst
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Benjamin Kaffenberger, MD principal investigator
Dermatologist
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 Ixekizumab in people with Pyoderma Gangrenosum, run by Ohio State University 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 7 inclusion and 12 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 23 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 (time frame: 12 Weeks). 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 23 Feb 2024.