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Clinical Trials in the USA / NCT06807281
Recruiting Phase 3

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

NCT06807281 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2025-12-02
Last updated
2026-09-04

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Abrocitinib

Abrocitinib: Abrocitinib administered as liquid oral suspension.

Study summary

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Eligibility

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria for the Extension Cohort: 1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old). • No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention. Inclusion Criteria for the De Novo Cohort: Age 1. Children aged 6 to \<12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Disease Characteristics: 2. 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; 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. Other Inclusion Criteria: 3. Body weight ≥15 kg Exclusion Criteria for the Extension Cohort: Medical Conditions: 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 the child or refer them 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. Prior/Concomitant Therapy: 2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol. 3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment. Diagnostic Assessments: 4. 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. 5. 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. Exclusion Criteria for the De Novo Cohort Medical Conditions: 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 * 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. Prior/Concomitant Therapy: 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 and strong inducers of CYP2C9 enzymes is not allowed in the study. Prior/Concurrent Clinical Study Experience: 6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1. Diagnostic Assessments: 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 Other Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Cahaba Dermatology & Skin Health Center Birmingham Alabama Recruiting
Arkansas Research Trials North Little Rock Arkansas Recruiting
Investigational Drug Service - Rady Childrens Hospital-San Diego San Diego California Not Yet Recruiting
University of California, San Diego/ Rady Children's Hospital - San Diego San Diego California Not Yet Recruiting
Solutions Through Advanced Research Jacksonville Florida Recruiting
Ada West Research - Meridian Meridian Idaho Not Yet Recruiting
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana Recruiting
Saint Louis University St Louis Missouri Recruiting
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic Charleston South Carolina Recruiting
Tribe Clinical Research, LLC Greenville South Carolina Recruiting
Texas Dermatology and Laser Specialists San Antonio Texas Not Yet Recruiting
Beijing Children's hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Shenzhen Children's Hospital Shenzhen Guangdong Recruiting
Hunan Children's Hospital Changsha Hunan Recruiting
Dermatology Hospital of Jiangxi Province Nanchang Jiangxi Not Yet Recruiting
Hangzhou Third People's Hospital Hangzhou Zhejiang Recruiting
Shanghai Children's Hospital Shanghai China Recruiting
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine Shanghai China Recruiting
Universitätsklinikum Münster Münster North Rhine-Westphalia Not Yet Recruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Dresden Saxony Not Yet Recruiting
Pécsi Tudományegyetem Klinikai Központ Pécs Baranya Recruiting
Trial Pharma Kft. Békéscsaba Bekes County Not Yet Recruiting
Clinexpert Kft. Budapest Pest County Recruiting
Queen's square Medical Facilities Queen's square Dermatology and Allergology Yokohama Kanagawa Recruiting
Dermatology and Ophthalmology Kume Clinic Sakai Osaka Recruiting
Sasamoto Children's Clinic Setagaya-ku Tokyo Recruiting
Fukuoka National Hospital Fukuoka Japan Recruiting
Saruta Dermatology Clinic Fukuoka Japan Not Yet Recruiting
Hospital Infantil de Mexico Federico Gomez Mexico City Mexico City Not Yet Recruiting
Eukarya Pharmasite S.C. Monterrey Nuevo León Not Yet Recruiting
Arké SMO S.A de C.V Veracruz Veracruz Ignacio de LA Llave Not Yet Recruiting
Servicios Hospitalarios de Mexico S.A. DE C.V. Chihuahua City Mexico Not Yet Recruiting
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska Lublin Lublin Voivodeship Recruiting
Centrum Medyczne Evimed Warsaw Masovian Voivodeship Recruiting
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska Chorzów Silesian Voivodeship Recruiting
Centrum Medyczne Angelius Provita Katowice Silesian Voivodeship Not Yet Recruiting
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak Lodz Łódź Voivodeship Recruiting
Dermedic Jacek Zdybski Ostrowiec Świętokrzyski Świętokrzyskie Voivodeship Recruiting
CHUS - Hospital Clinico Universitario Santiago de Compostela A Coruña [LA Coruña] Recruiting
Hospital General de Granollers Granollers Barcelona Recruiting

+ 1 more sites — see the full list on the official registry below.

More Pfizer trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06807281 on ClinicalTrials.gov ↗ ← All trials in the USA