A Study of Barzolvolimab in Patients With Prurigo Nodularis (NCT06366750) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Barzolvolimab in Patients With Prurigo Nodularis
United States, Canada, Croatia140 participantsStarted 2024-04-12
Plain-language summary
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
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
. Males and females, ≥18 years of age.
. Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
. At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
. An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
. Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
. Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
. Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
Exclusion criteria
. PN due to neuropathy, psychiatric disorders or medications.
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
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
Timeframe: From Day 1 (first dose) to Day 85 (week 12)
. Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
. Active unstable pruritic skin conditions in addition to PN.
. Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
. Females who are pregnant or nursing.
. Known hepatitis B or hepatitis C infection or active COVID-19 infection.
. Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.