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Recruiting NCT07236099

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

Phase II Interventional Prurigo Nodularis (PN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-322, Placebo.
Who it may be relevant to
Registry conditions: Prurigo Nodularis (PN). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China, Germany, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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]
Secondary outcome measures (6)
  • Improvement in PP NRS score [Time frame: Baseline through week 40]
  • Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) [Time frame: Baseline through week 40]
  • Dermatology Life Quality Index (DLQI) [Time frame: Baseline through week 40]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Baseline through week 40]
  • Maximum concentration (Cmax) [Time frame: Baseline through week 40]
  • Area Under Concentration Versus Time Curve (AUC) [Time frame: Baseline through week 40]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 15 centers
  • The Second Affiliated Hospital of Wannan Medical College — Wuhu
  • Peking University People's Hospital — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • The First Affiliated Hospital of Fujian Medical University — Fuzhou
  • Dermatology Hospital of Southern Medical University — Guangzhou
  • The First Hospital of Hebei Medical University — Shijiazhuang
  • Jingzhou Central Hospital — Jingzhou
  • Xiangya Hospital of Central South University — Changsha
  • … and 7 more centers
United States · 10 centers
  • Cahaba Dermatology and Skin Health Center — Birmingham
  • Medical Dermatology Specialists — Phoenix
  • Driven Research, LLC — Coral Gables
  • Cordova Research Institute — Sweetwater
  • Dawes Fretzin Clinical Research Group LLC — Indianapolis
  • The Derm Institute of West Michigan — Caledonia
  • Revival Research Institute, LLC — Troy
  • Minnesota Clinical Study Center — New Brighton
  • … and 2 more centers
Poland · 5 centers
  • AKK MEDlCAL Spółka z ograniczoną Odpowiedzialnością, Centrum Medyczne Tu się Leczy — Gdansk
  • Amicare Centrum Medyczne — Lodz
  • Centrum Badawcze Panaceum — Malbork
  • Twoja Przychodnia — Nowa Sól
  • Twoja Przychodnia Centrum Medyczne — Poznan
Germany · 4 centers
  • Uni Berlin Chartie Derma — Berlin
  • Rosenpark Research — Darmstadt
  • Uni Leipzig Derma — Leipzig
  • Dermatologischen Gemeinschaftspraxis Dres. Quist — Mainz

Identifiers

NCT: NCT07236099 · ICP-CL-00609

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗