Atopic Dermatitis study: Abrocitinib
Official title A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
ClinicalTrials.gov ID: NCT06807281
What this study is testing
What is Abrocitinib?
An investigational oral liquid medicine being studied as a potential treatment for moderate-to-severe atopic dermatitis in children. It is designed to inhibit Janus kinase 1 (JAK1), which helps reduce inflammation.
Also referred to as PF-04965842.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a liquid medicine called abrocitinib works well. It also checks how safe it is over a long time.
- Who it's for
- You may be able to join if you are a child aged 2 or older with moderate to severe eczema.
- What's involved
- You would take a liquid medicine by mouth. You might also use a cream on your skin.
- Time commitment
- The study lasts for 24 months.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 11
You may be able to join if
- 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...
- Children aged 6 to \<12 years at the time of informed consent/assent.
- 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...
- 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)
You likely can't join if
- Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
- 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...
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory...
- Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (baseline) or have superficial skin infections...
- History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the...
- Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
See the full eligibility 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...
- Children aged 6 to \<12 years at the time of informed consent/assent.
- 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
- Body weight ≥15 kg
- Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
- 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.
- 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...
- 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.
- 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.
- 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.
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- North Little Rock, Arkansas, United States
- San Diego, California, United States
- Jacksonville, Florida, United States
- Meridian, Idaho, United States
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- San Antonio, Texas, United States
- Beijing, Beijing Municipality, China
- Shenzhen, Guangdong, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
- Shanghai, China
- Pécs, Baranya, Hungary
- Békéscsaba, Bekes County, Hungary
- Budapest, Pest County, Hungary
- Yokohama, Kanagawa, Japan
- Sakai, Osaka, Japan
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; North Little Rock, Arkansas, United States; San Diego, California, United States; Jacksonville, Florida, United States; Meridian, Idaho, United States; Indianapolis, Indiana, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.