A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Recruiting · NCT06807268 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
AbrocitinibPlacebo
What this trial is about
This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
Who can take part
Age range
6 Years to 11 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Children aged 6 to \<12 years at the time of informed consent/assent.
- No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- Disease Characteristics:
- 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
- ther Inclusion Criteria:
- Body weight ≥15 kg
Exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions:
- 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.
- 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:
- Prior treatment with a systemic JAK inhibitor for AD. 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.
- 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.
- Prior/Concurrent Clinical Study Experience:
- Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.
Where it is running
46 locations listed across 9 US states.
- Cahaba Dermatology & Skin Health Center, LLC - Birmingham, Alabama, United States
- Arkansas Research Trials - North Little Rock, Arkansas, United States
- Investigational Drug Service - Rady Childrens Hospital-San Diego - San Diego, California, United States
- University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm - San Diego, California, United States
- Solutions Through Advanced Research - Jacksonville, Florida, United States
- Ada West Research - Meridian, Idaho, United States
- Dawes Fretzin Clinical Research Group, LLC - Indianapolis, Indiana, United States
- Saint Louis University - Department of Dermatology - St Louis, Missouri, United States
- Medical University of South Carolina - Department of Dermatology - Charleston, South Carolina, United States
- Medical University of South Carolina - South Carolina Translational Research Nexus Clinic - Charleston, South Carolina, United States
- Medical University of South Carolina - Walton Research Building - Charleston, South Carolina, United States
- Tribe Clinical Research, LLC - Greenville, South Carolina, United States
- Texas Dermatology and Laser Specialists - San Antonio, Texas, United States
- Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua) - Chihuahua City, Mexico
- Fukuoka National Hospital - Fukuoka, Japan
- Saruta Dermatology Clinic - Fukuoka, Japan
- University of Pecs - Pécs, Hungary
- Shanghai Children's Hospital - Shanghai, China
- Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine - Shanghai, China
- Hospital Universitario Miguel Servet - Zaragoza, Spain
- CHUS - Hospital Clinico Universitario - Santiago de Compostela, A Coruña [LA Coruña], Spain
- Pécsi Tudományegyetem Klinikai Központ - Pécs, Baranya, Hungary
- Hospital General de Granollers - Granollers, Barcelona [barcelona], Spain
- Beijing Children's hospital, Capital Medical University - Beijing, Beijing Municipality, China
- Trial Pharma Kft. - Békéscsaba, Bekes County, Hungary
- Shenzhen Children's Hospital - Shenzhen, Guangdong, China
- Hunan Children's Hospital - Changsha, Hunan, China
- Dermatology Hospital of Jiangxi Province - Nanchang, Jiangxi, China
- Queen's square Medical Facilities Queen's square Dermatology and Allergology - Yokohama, Kanagawa, Japan
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna - Krakow, Lesser Poland Voivodeship, Poland
- LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska - Lublin, Lublin Voivodeship, Poland
- Centrum Medyczne Evimed - Warsaw, Masovian Voivodeship, Poland
- Hospital Infantil de México Federico Gómez - Mexico City, Mexico City, Mexico
- Universitätsklinikum Münster - Münster, North Rhine-Westphalia, Germany
- Eukarya Pharmasite S.C. - Monterrey, Nuevo León, Mexico
- Dermatology and Ophthalmology Kume Clinic - Sakai, Osaka, Japan
- Clinexpert Kft. - Budapest, Pest County, Hungary
- Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden - Dresden, Saxony, Germany
- Shanghai Children's Hospital - Shanghai, Shanghai Municipality, China
- DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska - Chorzów, Silesian Voivodeship, Poland
- Centrum Medyczne Angelius Provita - Katowice, Silesian Voivodeship, Poland
- Sasamoto Children's Clinic - Setagaya-ku, Tokyo, Japan
- Arke SMO S.A. de C.V. - Veracruz, Veracruz, Mexico
- Hangzhou Third People's Hospital - Hangzhou, Zhejiang, China
- Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak - Lodz, Łódź Voivodeship, Poland
- Dermedic Jacek Zdybski - Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland