Trial Outcomes & Findings for An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum (NCT NCT03137160)
NCT ID: NCT03137160
Last Updated: 2024-02-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
12 Weeks
Results posted on
2024-02-23
Participant Flow
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
These patients will have histological testing to rule out competing etiologies and require 3rd party adjudication/confirmation on agreement of the diagnosis
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ixekizumab (Taltz)
n=4 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
49.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
|
Number meeting criteria for inclusion
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 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.
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
Outcome measures
| Measure |
Ixekizumab (Taltz)
n=4 Participants
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
|
|---|---|
|
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
|
Adverse Events
Ixekizumab (Taltz)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixekizumab (Taltz)
n=4 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
sepsis
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
infection
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Other adverse events
| Measure |
Ixekizumab (Taltz)
n=4 participants at risk
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
|
|---|---|
|
Cardiac disorders
hypotension
|
50.0%
2/4 • Number of events 2 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
fever
|
50.0%
2/4 • Number of events 3 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
vomitting
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
1/4 • Number of events 2 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
infection of ulcer
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
pneumonia
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
h influenza
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Infections and infestations
low WBC
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
|
Immune system disorders
low igG levels
|
25.0%
1/4 • Number of events 1 • Adverse event data was collected over 16 weeks per patient and 1 year for the trial. Patient 01: data collected for 16 weeks. Patient EOT at week 16 Patient 02: Data collected for 2 weeks. Lost to FU after week 2 Patient 03: data collected for 6 weeks. Patient EOT visit at week 6 Patient 04: data collected for 6 weeks. EOT visit at week 6
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Dr. Benjamin Kaffenberger, MD
The Ohio State University- Dermatology
Phone: 6143463399
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place