ABROCITINIB for Atopic dermatitis | Moderate-to-severe atopic dermatitis

Inclusion criteria

• {"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 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"}
• {"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. 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."}
• {"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. - 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."}
• {"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."}
• {"criterion_text":"- 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."}
• {"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."}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"vIGA (validated Investigator’s Global Assessment) 5-point scale measured at Week 12; responder defined as vIGA = 0 or 1 and ≥2-point reduction from baseline at Week 12."}
• {"endpoint_text":"- Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-75) at Week 12","definition_or_measurement_approach":"EASI total score measured at Week 12; responder defined as ≥75% improvement from baseline (EASI-75)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2","definition_or_measurement_approach":"WI-NRS score measured at Week 2; endpoint is change from baseline."}
• {"endpoint_text":"- Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12","definition_or_measurement_approach":"WI-NRS measured at Week 12; responder = ≥4-point improvement from baseline."}
• {"endpoint_text":"- Response based on achieving WI-NRS < 2 at Week 12","definition_or_measurement_approach":"WI-NRS measured at Week 12; responder = WI-NRS score <2."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"vIGA measured at all scheduled time points; responder defined as vIGA 0 or 1 and ≥2-point reduction from baseline at scheduled time points (excluding primary analysis time point)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"EASI total score assessed at scheduled time points; responders defined by percent improvement thresholds (≥50%, ≥75%, ≥90%, 100%) versus baseline."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"WI-NRS measured at scheduled time points; responder = ≥4-point improvement vs baseline."}
• {"endpoint_text":"- Response based on achieving WI-NRS <2 at all scheduled time points (except for the time point analyzed for the key secondary endpoint)","definition_or_measurement_approach":"WI-NRS measured at scheduled time points; responder = WI-NRS <2."}
• {"endpoint_text":"- Response based on achieving WI-NRS <2 and EASI-90 at all scheduled time points","definition_or_measurement_approach":"Combined endpoint requiring WI-NRS <2 and EASI-90 at scheduled time points."}
• {"endpoint_text":"- Time from baseline to achieving at least a 4- point improvement in the WI-NRS scale","definition_or_measurement_approach":"Time-to-event endpoint measuring days/weeks from baseline until first occurrence of ≥4-point improvement in WI-NRS."}
• {"endpoint_text":"- Percent CFB in EASI total score at all scheduled time points","definition_or_measurement_approach":"Percent change from baseline in EASI total score at scheduled time points."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change from baseline in WI-NRS measured at scheduled time points."}
• {"endpoint_text":"- CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points","definition_or_measurement_approach":"Change from baseline in percent BSA affected at scheduled time points."}
• {"endpoint_text":"- CFB in Children’s Dermatology Life Quality Index (CDLQI) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in CDLQI at scheduled time points."}
• {"endpoint_text":"- CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points","definition_or_measurement_approach":"Change from baseline in POEM at scheduled time points."}
• {"endpoint_text":"- CFB in Dermatitis Family Impact (DFI) score at all scheduled time points","definition_or_measurement_approach":"Change from baseline in DFI score at scheduled time points."}
• {"endpoint_text":"- Topical corticosteroids- and topical calcineurin inhibitor-free days","definition_or_measurement_approach":"Count of days without use of topical corticosteroids or topical calcineurin inhibitors during study period."}
• {"endpoint_text":"- CFB in the length of time scratching at night at all scheduled time points","definition_or_measurement_approach":"Change from baseline in reported duration of night-time scratching at scheduled time points."}
• {"endpoint_text":"- CFB in the sleep efficiency at all scheduled time points","definition_or_measurement_approach":"Change from baseline in measured/reported sleep efficiency at scheduled time points."}
• {"endpoint_text":"- The incidence of treatment-emergent adverse events, serious adverse events and adverse events leading to discontinuation","definition_or_measurement_approach":"Safety endpoints capturing incidence counts and proportions of TEAEs, SAEs, and AEs leading to discontinuation."}
• {"endpoint_text":"- The incidence of clinically significant laboratory abnormalities","definition_or_measurement_approach":"Incidence of pre-defined clinically significant laboratory abnormalities during the study."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Humoral immune response measurements (antibody titres) to DTaP/Tdap and/or pneumococcal vaccines in vaccinated participants."}
• {"endpoint_text":"- Acceptability and Palatability Questionnaire to rate overall formulation taste and dosing experience.","definition_or_measurement_approach":"Participant/parent questionnaire assessing taste and dosing experience of the oral suspension formulation."}

Methods

• Participant database letters (Participant Database Letter) to contact potential participants
• Referral letters (Referral Letter) for clinician-to-clinic referrals
• Doctor referral materials / Clinician-facing recruitment materials
• Study posters and study brochures for local site-based recruitment
• Media board materials for awareness campaigns
• Informed consent flipchart materials used during consent discussions
• Scout/email communications (document: Scout Email Comm) to reach potential participants

Germany

Earliest CTIS Part Ii Submission Date

20-06-2025

Latest Decision Or Authorization Date

08-10-2025

Processing Time Days

110

Number Of Sites

2

Number Of Participants

8

Poland

Earliest CTIS Part Ii Submission Date

02-07-2025

Latest Decision Or Authorization Date

15-10-2025

Processing Time Days

105

Number Of Sites

6

Number Of Participants

31

Spain

Earliest CTIS Part Ii Submission Date

03-06-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

276

Number Of Sites

3

Number Of Participants

8

Hungary

Earliest CTIS Part Ii Submission Date

28-05-2025

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

309

Number Of Sites

4

Number Of Participants

7

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Inc

Responsibilities

Central Laboratory

Name

Icon Clinical Research Ltd

Responsibilities

Site and Study Training

Name

Almac Clinical Service Limited

Responsibilities

Drug destruction

Name

Biofourmis, Inc

Responsibilities

Data repository for accelerometry data

Name

Threewire Inc (WCG Clinical, Inc.)

Name

Fisher Clinical Services Inc.

Name

Signant Health Global LLC

Name

Panoramic Digital Health SASU

Name

Syneos Health Inc.

Third parties

• {"country":"United States","full_name":"Biofourmis, Inc","duties_or_roles":"Data repository for accelerometry data","organisation_type":"Industry"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Panoramic Digital Health SASU","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United States","full_name":"PPD Inc","duties_or_roles":"Central Laboratory","organisation_type":"Industry"}
• {"country":"United States","full_name":"Threewire Inc (WCG Clinical, Inc.)","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"United Kingdom","full_name":"Almac Clinical Service Limited","duties_or_roles":"Drug destruction","organisation_type":"Industry"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Ltd","duties_or_roles":"Site and Study Training","organisation_type":"Industry"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}