Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 4:21 AM
Study NCT ID:
NCT04274166
Status:
WITHDRAWN
Last Update Posted:
2021-05-28
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
The Efficacy and Safety of Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Contracting never completed, closed the IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to find out what effects (good and bad) secukinumab has on the subject and their pyoderma gangrenosum.
Secukinumab is a type of medicine called human monoclonal antibodies. Monoclonal antibodies are proteins that recognize and attach to other specific proteins (in this case, immune system hormones called "cytokines") that your body produces. The cytokine (a "messenger" protein in the body) that secukinumab binds to and reduces the activity of is a naturally occurring cytokine called interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A may cause symptoms PG.
Secukinumab is a type of medicine called human monoclonal antibodies. Monoclonal antibodies are proteins that recognize and attach to other specific proteins (in this case, immune system hormones called "cytokines") that your body produces. The cytokine (a "messenger" protein in the body) that secukinumab binds to and reduces the activity of is a naturally occurring cytokine called interleukin-17A (IL-17A). IL-17A is believed to be partly responsible for inflammation (pain, swelling, redness), and researchers believe that IL-17A may cause symptoms PG.
Detailed Description:
This is a prospective, single center, Phase IIa study of secukinumab in the treatment of subjects diagnosed with PG. Subjects will be evaluated at Screening, Baseline (week 0), Week 1, Week 2, Week 3, Week 4, and then every 4 weeks for 24 weeks. The total duration of treatment is up to 20 weeks. Subjects may be treated for shorter durations if the lesions clear prior to week 20. Subjects will have a follow-up visit at 24 weeks, or 4 weeks after the last dose of study drug. Subjects will also have standard of care wound dressings done at each visit. Subjects will be given 300 mg of secukinumab SQ at week 0, 1, 2, 3, and 4, followed by injections every 4 weeks, for up to 20 weeks. Subjects may receive a dose increase at week 16 (if there is not at least a 25% reduction in target lesion size) to 300 mg every 2 weeks.
* Complete Blood Count (CBC), Comprehensive Metabolic panel (CMP), C- reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Hepatitis panel, HIV test, Pregnancy test, and QuantiFERON gold TB test will be performed at screening. (Appendix 6)
* CBC, CMP, CRP, ESR will be performed at week 8 and week 20.
* Pain rating by Likert scale (A 10-point scale to rate the level of pain - Appendix 2), an Investigator Global Assessment (IGA) (Appendix 3), Subject Global Assessment (SGA) (Appendix 3), and Ulcer Lesion Assessment (Appendix 5) will be done at Screening, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
* Lesion photography will be done at Screening and all visits.
* Infection and adverse event assessments and concomitant medication assessments will be performed at each visit.
* Quality of life will be measured with the Dermatology Life Quality Index (DLQI) at Baseline and Week 20 (Appendix 4).
* Complete Blood Count (CBC), Comprehensive Metabolic panel (CMP), C- reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Hepatitis panel, HIV test, Pregnancy test, and QuantiFERON gold TB test will be performed at screening. (Appendix 6)
* CBC, CMP, CRP, ESR will be performed at week 8 and week 20.
* Pain rating by Likert scale (A 10-point scale to rate the level of pain - Appendix 2), an Investigator Global Assessment (IGA) (Appendix 3), Subject Global Assessment (SGA) (Appendix 3), and Ulcer Lesion Assessment (Appendix 5) will be done at Screening, Baseline, and at Weeks 2, 4, 8, 12, 16, 20, and 24.
* Lesion photography will be done at Screening and all visits.
* Infection and adverse event assessments and concomitant medication assessments will be performed at each visit.
* Quality of life will be measured with the Dermatology Life Quality Index (DLQI) at Baseline and Week 20 (Appendix 4).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Huang_IIT_CAIN457AUS24T | OTHER_GRANT | Novartis | View |