Pyoderma Gangrenosum
Conditions
Brief summary
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.
Interventions
BIOLOGICALIxekizumab
Injection
Sponsors
Eli Lilly and Company
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. a. 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. e. Wound debridement within 2 weeks of Day 0; dressing changes allowed per investigator discretion. g. 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. i. 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.
Exclusion criteria
* Major
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 | 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 |
Countries
United States
Participant flow
Recruitment details
The study will be conducted in Columbus, OH, at The Ohio State University (OSU) dermatology clinical trials center. Both the principal investigator and the OSU dermatology center have extensive experience with industry-sponsored clinical trials in PG, having completing two trials in 2015-16
Pre-assignment details
These patients will have histological testing to rule out competing etiologies and require 3rd party adjudication/confirmation on agreement of the diagnosis
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab (Taltz) 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.
Ixekizumab: Injection | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Ixekizumab (Taltz) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Age, Continuous | 49.5 years | — |
| Number meeting criteria for inclusion | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 3 / 4 |
Outcome results
Primary
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
Time frame: 12 Weeks
Population: The proportion of subjects achieving a two point reduction in the five-point investigator global assessment (IGA) for the target ulcer from baseline to week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab (Taltz) | The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12 | 0 Participants |
Comparison: This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).p-value: 1Fisher Exact