Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT07216027
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS 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:
The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.
The study is seeking participants who:
1. Are 18 years of age or more;
2. Were confirmed to have AD at least 6 months ago;
3. Do not have a suitable prescribed medicine for AD;
4. Are considered by their doctors to have moderate to severe AD.
Eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12, and have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. Participants will have blood and urine tests and must answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to participants receiving placebo. This will help to understand if PF-08049820 is safe and effective.
The study is seeking participants who:
1. Are 18 years of age or more;
2. Were confirmed to have AD at least 6 months ago;
3. Do not have a suitable prescribed medicine for AD;
4. Are considered by their doctors to have moderate to severe AD.
Eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12, and have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. Participants will have blood and urine tests and must answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to participants receiving placebo. This will help to understand if PF-08049820 is safe and effective.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025-522965-31-00 | REGISTRY | CTIS (EU) | View |