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)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation — 0-24 months The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.
Trial sites (41)
Facility
City
Region
Status
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.
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.
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