Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651489
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Efficacy of Guselkumab in Treating Hailey Hailey Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease An Open-label Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hailey-Hailey disease HHD is a debilitating genetic skin disorder affecting mainly body folds with erythema and painful erosions and blisters Histopathological findings include epidermal hyperplasia suprabasilar clefting dyskeratosis and acantholysis of keratinocytes A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing
Several treatment options have been proposed for this chronic and disabling disorder however there is no reproducibly effective therapeutic for it
The primary objective is to evaluate the treatment response of guselkumab Single-center non-randomized single-arm open-label phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD
Several treatment options have been proposed for this chronic and disabling disorder however there is no reproducibly effective therapeutic for it
The primary objective is to evaluate the treatment response of guselkumab Single-center non-randomized single-arm open-label phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD
Detailed Description:
Several treatment options have been proposed for HHD as chronic and disabling disorder however there is no reproducibly effective therapeutic for it
The primary objective is to evaluate the treatment response of guselkumab After the participant has been deemed an appropriate candidate for the study and has signed the consent form they will be enrolled All participants will be started on guselkumab 100mg at the FDA-approved psoriasis dose and will be seen for clinical follow-up 4 12 24 weeks after initiation of therapy A 12-week follow-up period will be conducted post-administration of the final dose of guselkumab to monitor safety Laboratory monitoring including Complete Blood Count Basic metabolic panel Liver function tests and pregnancy test if applicable will also be performed at 1 month 3 months and 6 months after starting therapy At each visit except Week 20 a full HP complete Review of Systems and physical examination will be performed Outcomes will be assessed and full-body photography will be performed at each visit except Week 20 Research tissue samples skin biopsies will be obtained at baseline prior to therapy after 24 weeks of treatment in all participants Research blood will be obtained at screening baseline and after 4 12 and 24 weeks of guselkumab therapy
The primary objective is to evaluate the treatment response of guselkumab After the participant has been deemed an appropriate candidate for the study and has signed the consent form they will be enrolled All participants will be started on guselkumab 100mg at the FDA-approved psoriasis dose and will be seen for clinical follow-up 4 12 24 weeks after initiation of therapy A 12-week follow-up period will be conducted post-administration of the final dose of guselkumab to monitor safety Laboratory monitoring including Complete Blood Count Basic metabolic panel Liver function tests and pregnancy test if applicable will also be performed at 1 month 3 months and 6 months after starting therapy At each visit except Week 20 a full HP complete Review of Systems and physical examination will be performed Outcomes will be assessed and full-body photography will be performed at each visit except Week 20 Research tissue samples skin biopsies will be obtained at baseline prior to therapy after 24 weeks of treatment in all participants Research blood will be obtained at screening baseline and after 4 12 and 24 weeks of guselkumab therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None