NCT07236099 · Beijing InnoCare Pharma Tech Co., Ltd.
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
What this study is about
Evaluate the effectiveness and safety of ICP-332 in participants with Prurigo Nodularis (PN)
View original scientific description
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Interventions
DRUG
ICP-322
ICP-322 Tablets
DRUG
Placebo
ICP-332 Placebo Tablets
Primary outcome measures
Peak pruritus-numeric rate scale (PP NRS)
Time frame: Baseline to week 16
Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16. Participants will be asked to rate their itch at the worst moment during the previous 24 hours. On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Voluntarily sign informed consent forms before any investigational procedure(s) are performed.
- Male or female aged between 18 and 75 years at the time of signing the informed consent.
- Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
- At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
- PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
- IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
- History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks). Willingness to avoid pregnancy or fathering children
Exclusion criteria
- Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
- Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Where
- Mayfield Heights, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations