A Study of Barzolvolimab in Patients With Atopic Dermatitis (NCT06727552) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Barzolvolimab in Patients With Atopic Dermatitis
United States131 participantsStarted 2024-12-18
Plain-language summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥ 18 years of age
. Diagnosis of chronic atopic dermatitis (AD) for at least 1 year
. Onset of symptoms at least 1 year prior and current symptoms consistent with moderate to severe AD as defined by:
. EASI ≥ 12 at Visit 1 and EASI ≥ 16 at Visit 2
. Body Surface Area of Involvement (BSA) ≥ 10% at Visit 1 and Visit 2
. IGA score ≥ 3 at Visit 1 and Visit 2
. Severe itch, defined by weekly average of daily PP-NRS score of ≥ 5, during the 7 days prior to treatment
. Documented history of inadequate response to treatment with topical medications or for whom topical medications are otherwise medically inadvisable.
Exclusion criteria
. Any other active pruritic skin diseases that would confound AD assessments based on the Investigator's clinical judgment.
. Phototherapy with ultraviolet (UV) A or UVB within 4 weeks of Visit 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change from Baseline in the weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) score at Week 16
Timeframe: From Day 1 (first dose) to Day 113 (week 16)
. Planned or anticipated use of any prohibited medications at any time during the study.
. Prior receipt of barzolvolimab or other anti-KIT therapy. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.