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NCT Number: NCT07236099

Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICP-322

Drug

ICP-322 Tablets

Placebo

Drug

ICP-332 Placebo Tablets

Primary outcomes

  1. 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'.

Secondary outcomes

  1. Improvement in PP NRS score

    Time frame: Baseline through week 40

    Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time

  2. Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)

    Time frame: Baseline through week 40

    Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time

  3. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline through week 40

    Change from baseline in Dermatology Life Quality Index (DLQI) score over time. The DLQI comprises 10 items assessing the impact of skin disease on patients' health-related quality of life (HRQoL) over the previous week. Overall scoring ranges from 0 to 30, with a high score indicative of a poor HRQoL

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: Baseline through week 40

  5. Maximum concentration (Cmax)

    Time frame: Baseline through week 40

    Maximum concentration (Cmax) of ICP-322

  6. Area Under Concentration Versus Time Curve (AUC)

    Time frame: Baseline through week 40

    Area Under Concentration Versus Time Curve (AUC) of ICP-322

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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