A Phase 3 interventional study of Abrocitinib and Placebo in Atopic Dermatitis, sponsored by Pfizer. Not yet recruiting. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This clinical study is designed to test how well a medicine called abrocitinib works and how safe it is for young children (ages 2 to under 6) who have moderate-to-severe eczema (also known as atopic dermatitis).Eczema is a skin condition that can cause the skin to be dry, itchy, have scaly patches, blisters and skin infections.
How the study works:
Children will be randomly placed into two groups:
This study is seeking for children:
The medicine is given once a day as a liquid. The amount given depends on the child's body weight. If the child's eczema doesn't improve enough between weeks 4 and 8, the dose might be increased (still without anyone knowing which group they're in), unless the child can't tolerate it.
All children will also use standard medicated creams during the study. The study will be up to 24 weeks long and there will be a screening period (up to 28 days) to make sure each child qualifies for the study.
This is a 16-week, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to placebo in participants aged 2 to \<6 years with moderate-to-severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Participants who continue to meet eligibility criteria at baseline will be randomized 2:1 to abrocitinib oral suspension (at 100 mg adult equivalent dose level [AED] once daily [QD]) or matching placebo. Participants will be stratified by their baseline vIGA (score of 3 or 4). At the starting dose level of 100 mg QD AED, the dose volume (in mL of oral suspension) will depend on the participant's body weight.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 90 is close to the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Disease Characteristics:
For countries outside the US:
Eligible participants must have:
For US only:
Eligible participants are those whose disease is not adequately controlled with at least 1 systemic therapy or when the use of systemic therapies is inadvisable.
Other Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive liquid oral suspension of Abrocitinib.
Drug: Abrocitinib
Participants will receive liquid oral suspension of matching placebo.
Drug: Placebo
Administered orally
Also known as: PF-04965842
Administered orally
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
The difference in percentage of responders based on vIGA at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
Time frame: Baseline, week 12
Response based on achieving ≥75% improvement from baseline in Eczema and Severity Index (EASI) at Week 12
The difference in percentage of responders based on EASI-75 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: Week 12
Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2
The difference in mean CFB in WSI-NRS total score at Week 2 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: Baseline, Week 2
Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12
The difference in percentage of responders based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
Time frame: Week 12
Response based on achieving WSI-NRS <2 at Week 12
The difference in percentage of responders based on achieving WSI-NRS \<2 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
Time frame: Week 12
No study locations are listed for this record.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Supporting information: Study protocol
Data sharing details ↗ · www.pfizer.com
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abrocitinib