BridgeMD
New treatment option for Eczema
Official title A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
ClinicalTrials.gov ID: NCT06807268
What this study is testing
What is Abrocitinib?
Abrocitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eczema.
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 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.
- Phase 3: a large, late-stage study
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- 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...
- 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...
- 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)...
- Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and...
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply: Medical Conditions: Any medical or psychiatric condition including...
- Infections:
- 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.
- Infection with HIV, hepatitis B, and/or hepatitis C
See the full eligibility 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...
- 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 Other...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- North Little Rock, Arkansas, United States
- San Diego, California, United States
- Jacksonville, Florida, 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
- Nanchang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Shanghai, China
- Münster, North Rhine-Westphalia, Germany
- Dresden, Saxony, Germany
- Pécs, Baranya, Hungary
- Békéscsaba, Bekes County, Hungary
+ 18 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; North Little Rock, Arkansas, United States; San Diego, California, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States; St Louis, Missouri, United States and 32 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.