A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age with Moderate-to-Severe Atopic Eczema

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

30 Sep 2025 → ongoing

Decision date (initial)

2025-07-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer, Inc

External identifiers

EU CT number

2023-509121-51-00

ClinicalTrials.gov

NCT06807268

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate efficacy of abrocitinib compared with placebo when co-administered with background topical medications in children 6 to <12 years of age with moderate-to-severe AD

Secondary objectives 5

1. To evaluate effect of abrocitinib compared with placebo when co-administered with background topical medications on pruritus in children 6 to <12 years of age with moderate-to-severe AD
2. To evaluate the efficacy of abrocitinib
3. To evaluate the safety of abrocitinib
4. To assess effect of abrocitinib on humoral response to vaccines
5. Evaluate the acceptability and palatability of abrocitinib oral suspension formulation

Conditions and MedDRA coding

Moderate-to-Severe Atopic Dermatitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002312-PIP01-17

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Children aged 6 to <12 years at the time of informed consent/assent.
2. 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
3. Body weight ≥15 kg

Exclusion criteria 8

1. 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. If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.
2. Have any of the following medical conditions:  Infections: - Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections 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 (Section 8.3.6 and Appendix 10). - Evidence of active TB or inadequately treated latent TB.  Skin Conditions: - Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.  Other Conditions: - Documented history of skeletal dysplasia. - Documented history of retinal detachment. - History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction. - Prior history of leukemia, lymphoma, sarcoma or any other malignancy. - Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency. - Any other medical conditions that in the investigator’s judgment make the participant inappropriate for the study.
3. Prior treatment with a systemic JAK inhibitor for AD.
4. 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.
5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.
6. Previous administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, of Day 1.
7. Hepatic and/or renal and/or hematological abnormalities defined as:  AST >2 x ULN  Hemoglobin <10 g/dL  ALT >2 x ULN  ANC <1000/mm3  Total bilirubin ≥1.5 x ULN  ALC <500/mm3  eGFR 60 mL/min/1.73 m2  Platelets <150,000 /mm3
8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-75) at Week 12

Secondary endpoints 22

1. Change from baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2
2. Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12
3. Response based on achieving WI-NRS < 2 at Week 12
4. Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points (except for the time point analyzed for the primary endpoints)
5. Response based on achieving ≥50%, ≥75%, ≥90%, 100% improvement from baseline in the EASI total score (EASI-50, EASI-75, EASI-90, EASI-100) at all scheduled time points (except for the time point analyzed for the primary endpoints)
6. Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
7. Response based on achieving WI-NRS <2 at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
8. Response based on achieving WI-NRS <2 and EASI-90 at all scheduled time points
9. Time from baseline to achieving at least a 4- point improvement in the WI-NRS scale
10. Percent CFB in EASI total score at all scheduled time points
11. CFB in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
12. CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points
13. CFB in Children’s Dermatology Life Quality Index (CDLQI) at all scheduled time points
14. CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points
15. CFB in Dermatitis Family Impact (DFI) score at all scheduled time points
16. Topical corticosteroids- and topical calcineurin inhibitor-free days
17. CFB in the length of time scratching at night at all scheduled time points
18. CFB in the sleep efficiency at all scheduled time points
19. The incidence of treatment-emergent adverse events, serious adverse events and adverse events leading to discontinuation
20. The incidence of clinically significant laboratory abnormalities
21. Immune response to diphtheria, tetanus, and acellular pertussis vaccine (DTaP/Tdap) and/or pneumococcal vaccines in participants who received DTaP/Tdap and/or pneumococcal vaccination
22. Acceptability and Palatability Questionnaire to rate overall formulation taste and dosing experience.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 9

Locations

4 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications