Atopic DermatitisPhase 3NCT07823595
Abrocitinib Treatment of Atopic Dermatitis in Children 2 to Less Than 6 Years of Age
A Phase 3 study testing Abrocitinib in people with Atopic Dermatitis, run by Pfizer.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Abrocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2027to 10 Apr 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to <6 years at the time of informed consent /assent.
- Disease Characteristics:
- All participants must meet all of the following 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;
- 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 WSI-NRS ≥4).
- For countries outside the US:
Show all 14Show fewer
- Eligible participants must have:
- a documented history within 6 months before the screening visit of inadequate response to treatment with topical medicated therapy for AD (eg, TCS and TCI) for at least 4 weeks, or;
- required at least 1 systemic therapy for control of their disease.
- 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.
- Prior systemic therapies may include biologics such as dupilumab, oral agents such as corticosteroids, cyclosporine, methotrexate Note that an inadequate response to topical treatments alone is not sufficient for eligibility in the US.
- Other Inclusion Criteria:
- Body weight ≥10 kg.
Who cannot join
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline), or have non-typical pediatric superficial skin infections (excluding common self-limiting viral conditions such as verruca vulgaris and molluscum contagiosum) within 1 week of Day 1. History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
- Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- Infection with HIV, hepatitis B, and/or hepatitis C.
- Evidence of active TB or inadequately treated latent TB.
- Prior treatment with a systemic JAK inhibitor for AD.
- Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.
- Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, sensitive P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates with narrow therapeutic index are not allowed in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 2 TO LESS THAN 6 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
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:
Read more
- Children will be randomly placed into two groups:
- 2 out of 3 will get the real medicine (abrocitinib).
- 1 out of 3 will get a placebo (a look-alike liquid with no active medicine).
- Neither the families nor the doctors will know which group each child is in (this is called double-blind).
This study is seeking for children:
- between 2 and under 6 years old.
- Who have had eczema for at least 1 year.
- Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores.
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.
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Abrocitinib, Placebo
- Keywords
- eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Also called PF-04965842
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Abrocitinib | Experimental | Participants will receive liquid oral suspension of Abrocitinib. Receives: Drug: Abrocitinib |
| Matching Placebo | Placebo comparator | Participants will receive liquid oral suspension of matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Week 12
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 May 2027 (estimated)
- Primary completion10 Apr 2029 (estimated)
- Study completion10 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823595
- Sponsor's protocol ID
- B7451030
- Other IDs
- 2025-523215-11-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 2 TO LESS THAN 6 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT07823595
- Acronym / sponsor ID
- B7451030
- Conditions
- Atopic Dermatitis
- Keywords
- eczema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 10 Apr 2029 (estimated)
- Study completion
- 10 Apr 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 2 out of 3 will get the real medicine (abrocitinib).
- 1 out of 3 will get a placebo (a look-alike liquid with no active medicine).
- Neither the families nor the doctors will know which group each child is in (this is called double-blind).
This study is seeking for children:
- between 2 and under 6 years old.
- Who have had eczema for at least 1 year.
- Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abrocitinib | Experimental | Drug: AbrocitinibParticipants will receive liquid oral suspension of Abrocitinib. |
| Matching Placebo | Placebo comparator | Drug: PlaceboParticipants will receive liquid oral suspension of matching placebo. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Children aged 2 to <6 years at the time of informed consent /assent.
- All participants must meet all of the following 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;
- 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 WSI-NRS ≥4).
- a documented history within 6 months before the screening visit of inadequate response to treatment with topical medicated therapy for AD (eg, TCS and TCI) for at least 4 weeks, or;
Key exclusion criteria (8 listed)
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline), or have non-typical pediatric superficial skin infections (excluding common self-limiting viral conditions such as verruca vulgaris and molluscum contagiosum) within 1 week of Day 1. History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.
- Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- Infection with HIV, hepatitis B, and/or hepatitis C.
- Evidence of active TB or inadequately treated latent TB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibAlso: PF-04965842Administered orally | Drug | Abrocitinib |
| PlaceboAdministered orally | Drug | Matching Placebo |
Primary outcome
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: Baseline, 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.
Response based on achieving ≥75% improvement from baseline in Eczema and Severity Index (EASI) at Week 12
Time frame: 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
3 secondary outcomes
Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2
Time frame: Baseline, Week 2
Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12
Time frame: Week 12
Response based on achieving WSI-NRS <2 at Week 12
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abrocitinib in people with Atopic Dermatitis, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Baseline, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.