Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
Study NCT ID:
NCT06807268
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-01-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
Detailed Description:
Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-509121-51-00 | REGISTRY | CTIS (EU) | View |