NCT06807268 · Pfizer
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Abrocitinib
Abrocitinib administered as liquid oral suspension.
OTHER
Placebo
Placebo administered as liquid oral suspension.
Primary outcome measures
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
Time frame: At week 12
The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12
Time frame: At week 12
The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Children aged 6 to \<12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Disease Characteristics: Participants who meet all of the following AD criteria:
- A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria\[19\]; and
- A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and
- Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy Other Inclusion Criteria: Body weight ≥15 kg
Exclusion criteria
- Participants are excluded from t
Where
- Birmingham, Alabama
- North Little Rock, Arkansas
- San Diego, California
- Jacksonville, Florida
- Indianapolis, Indiana
- St Louis, Missouri
- Charleston, South Carolina
- Greenville, South Carolina
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations