ABROCITINIB for Moderate-to-severe atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Participants who have completed the treatment phase of the qualifying parent study (age 2 to <12 years old)."}
• {"criterion_text":"- Children aged 6 to <12 years at the time of informed consent/assent."}
• {"criterion_text":"- Participants who meet all of the following AD criteria:  A documented diagnosis of chronic AD for at least 6 months 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."}
• {"criterion_text":"- Body weight ≥15 kg"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study."}
• {"criterion_text":"- Previous administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, of Day 1."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9."}
• {"criterion_text":"- Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment."}
• {"criterion_text":"- Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.  Available results from assessments performed as part of the Week 12 visit of the parent study should be evaluated to determine eligibility and appropriateness of the participant to be enrolled. Clinically significant abnormalities on physical examination at Week 12 visit or any unresolved, clinically significant abnormality from results of ECGs (if applicable), safety laboratory assessments, or vital signs measurements recorded in the parent study that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study, are exclusionary."}
• {"criterion_text":"- Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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. - Known or suspected infection with HIV, hepatitis B, and/or hepatitis C (Section 8.3.6). - 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."}
• {"criterion_text":"- Prior treatment with a systemic JAK inhibitor for AD."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Overall treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs that lead to discontinuation of study intervention.","definition_or_measurement_approach":"Measured as incidence and nature of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation of study intervention reported during the study period (safety monitoring and standard AE reporting as per protocol)."}

Secondary endpoints

• {"endpoint_text":"- Clinically significant laboratory abnormalities","definition_or_measurement_approach":"Laboratory safety results evaluated for clinical significance per protocol-defined thresholds."}
• {"endpoint_text":"- Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and ≥2-point reduction from baseline1 at all scheduled time points.","definition_or_measurement_approach":"Responder defined as vIGA 0 or 1 plus ≥2-point reduction from baseline at scheduled visits."}
• {"endpoint_text":"- Response based on achieving a ≥4-point improvement from baseline1 in the Worst Itch-Numerical Rating Scale (WI-NRS) at all scheduled time points.","definition_or_measurement_approach":"Responder defined as ≥4-point improvement from baseline on WI-NRS at scheduled visits."}
• {"endpoint_text":"- Response based on achieving a ≥4-point improvement from baseline1 in the Worst Scratch/Itch-Numerical Rating Scale (WSI-NRS) at all scheduled time points.","definition_or_measurement_approach":"Responder defined as ≥4-point improvement from baseline on WSI-NRS at scheduled visits."}
• {"endpoint_text":"- Response based on achieving ≥50%, ≥75%, ≥90%, 100% improvement from baseline1 in the Eczema Area and Severity Index (EASI) total score (EASI-50, EASI-75, EASI-90, EASI-100) at all scheduled time points.","definition_or_measurement_approach":"Percent improvements from baseline in EASI total score calculated at scheduled visits; responder rates computed for EASI-50/75/90/100."}
• {"endpoint_text":"- Percent change from baseline (CFB)1 in EASI total score at all scheduled time points.","definition_or_measurement_approach":"Percent change from baseline in EASI total score computed per scheduled visit."}
• {"endpoint_text":"- CFB1 in the percentage Body Surface Area (BSA) affected at all scheduled time points.","definition_or_measurement_approach":"Percent change from baseline in percentage BSA affected measured at scheduled visits."}
• {"endpoint_text":"- Loss of response due to protocol-defined flare2","definition_or_measurement_approach":"Occurrence of protocol-defined disease flare leading to loss of response assessed per protocol flare definition."}
• {"endpoint_text":"- CFB1 in Children’s Dermatology Life Quality Index (CDLQI) at all scheduled time points.","definition_or_measurement_approach":"Change from baseline in CDLQI score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in Infants’ Dermatitis Quality of Life (IDQOL) at all scheduled time points.","definition_or_measurement_approach":"Change from baseline in IDQOL score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in Patient-Oriented Eczema Measure (POEM) at all scheduled time points.","definition_or_measurement_approach":"Change from baseline in POEM score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in Dermatitis Family Impact (DFI) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in DFI score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in Patient Reported Global Impression of Severity (PGIS) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in PGIS score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in OGIS score measured at scheduled visits."}
• {"endpoint_text":"- CFB1 in the EuroQol- 5 Dimension Youth (EQ-5D-Y) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in EQ-5D-Y score measured at scheduled visits."}
• {"endpoint_text":"- Number of topical corticosteroids- and / or topical calcineurin inhibitor-free days.","definition_or_measurement_approach":"Number of days without topical corticosteroids and/or topical calcineurin inhibitors recorded for participants."}
• {"endpoint_text":"- Proportion of participants achieving satisfactory response in Tetanus, Diphtheria and Acellular Pertussis Vaccine (Tdap)/Diphtheria, Tetanus & Pertussis vaccine (DTaP) and/or pneumococcal antibody titers as appropriate in participants who receive Tdap/DTaP and/or pneumococcal vaccinations","definition_or_measurement_approach":"Proportion achieving predefined satisfactory antibody titers post-vaccination among participants who receive indicated vaccines."}

Methods

• Study brochures distributed at sites and via country-specific materials (documents: Study Brochure in PL, DE, ES, HU).
• Physician/doctor referral letters to refer eligible patients to sites (Referral Letter documents available PL/DE/ES/HU).
• Participant database letters contacting potential participants from existing participant databases (Participant Database Letter documents PL/DE/ES).
• Study posters and media boards displayed at sites and public areas (Study Poster and Media Board documents PL/DE/ES).
• Informed consent flipchart and scout email communications for parent/guardian and child engagement (Informed Consent Flipchart, L5_Scout_Email comm).
• Referral and recruitment materials localized by country (documents available per country: Poland, Germany, Spain, Hungary) and translated versions provided.

Poland

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

31

Number Of Sites

6

Number Of Participants

84

Germany

Earliest CTIS Part Ii Submission Date

16-07-2025

Latest Decision Or Authorization Date

05-08-2025

Processing Time Days

20

Number Of Sites

2

Number Of Participants

34

Spain

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

05-11-2025

Processing Time Days

110

Number Of Sites

3

Number Of Participants

33

Hungary

Earliest CTIS Part Ii Submission Date

24-06-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

55

Number Of Sites

4

Number Of Participants

34

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Ppd Inc.

Responsibilities

sponsorDuties codes: 4

Name

Icon Clinical Research Limited

Responsibilities

Site and Study Training (sponsorDuties code 15)

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: 4, 5

Name

Fisher Clinical Services Inc.

Responsibilities

sponsorDuties codes: 4

Name

Almac Clinical Services Limited

Responsibilities

Drug destruction (sponsorDuties code 15)

Name

Signant Health Global LLC

Responsibilities

sponsorDuties codes: 7

Name

Threewire Inc (WCG Clinical, Inc.)

Responsibilities

sponsorDuties codes: 2

Third parties

• {"country":"France","full_name":"Panoramic Digital Health SASU","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Industry"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Site and Study Training (sponsorDuties code 15; value: \"Site and Study Training\")","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Biofourmis, Inc","duties_or_roles":"Data repository for accelerometry data (sponsorDuties code 15; value provided)","organisation_type":"Industry"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug destruction (sponsorDuties code 15; value: \"Drug destruction\")","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 4, 5","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Threewire Inc (WCG Clinical, Inc.)","duties_or_roles":"sponsorDuties codes: 2","organisation_type":"Industry"}
• {"country":"Hungary","full_name":"Trial Pharma Kft.","duties_or_roles":"sponsorDuties codes: (site-level third party for Hungary trial sites)","organisation_type":"Pharmaceutical company"}