Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients (NCT07620561) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
United States15 participantsStarted 2026-06
Plain-language summary
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
Who can participate
Age range
18 Years – 80 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:
* Age 18-80
* Diagnosis of Prurigo Nodularis (PN) for at least 1 year
* Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
* Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
* Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug
Exclusion Criteria:
* Prior participation in a lebrikizumab study
* History of anaphylaxis
* History of or active HIV
* Active hepatitis or known liver cirrhosis
* History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
* Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
* Current or recent parasitic infection
* Immunocompromised individuals
* Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
* Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
* Current or recent treatment with biologic drug…
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 weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24
Timeframe: Baseline; Week 24
2
Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1