Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509984
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
A 20-Week Study Assessing the Efficacy of Apremilast in Patients With EB Simplex Generalized
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EBULO A 20-Week Multicentre Open Study Assessing the Efficacy and Safety of Apremilast in Patients 6 Years of Age With EB Simplex Generalized
Status:
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:
EBULO
Brief Summary:
The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients 6 years of age with EB simplex generalized The main question it aims to answer are describe efficacity of this treatment
Participants will take treatments and have to use bullets during the study period
Participants will take treatments and have to use bullets during the study period
Detailed Description:
The patient will have 7 visits After Confirmation of inclusion criteria and no exclusion criteria the study will be explain to the patient after signing the inform consent and be included in the study Treatment Period Period 1 challenge period This period will be the first treatment period that will occur from 8 weeks During this period the patient will see the doctor at the hospital he will perform the study procedures The second period dechallenge period 2 All patients stop their treatment for 4 weeks
The second treatment period - rechallenge period 3 the patient will take the treatment for a second 8 weeks period At week 20 - End of study
At each visit
The investigator at each visit compliance to the treatment and adverse events Measure vital signs and perform clinical examination
The patient will assess the different questionnaires for the study
The second treatment period - rechallenge period 3 the patient will take the treatment for a second 8 weeks period At week 20 - End of study
At each visit
The investigator at each visit compliance to the treatment and adverse events Measure vital signs and perform clinical examination
The patient will assess the different questionnaires for the study
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