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

Официальное название

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

Обзор

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

Вмешательства

• Препарат ICP-322
  ICP-322 Tablets
• Препарат Placebo
  ICP-332 Placebo Tablets

Первичные конечные точки

• Peak pruritus-numeric rate scale (PP NRS) [Срок оценки: Baseline to week 16]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• The Second Affiliated Hospital of Wannan Medical College — Wuhu
• Peking University People's Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Dermatology Hospital of Southern Medical University — Гуанчжоу
• The First Hospital of Hebei Medical University — Shijiazhuang
• Jingzhou Central Hospital — Jingzhou
• Xiangya Hospital of Central South University — Чанша
• … и ещё 7 центров

США · 10 центров

• 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
• … и ещё 2 центра

Польша · 5 центров

• 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

Германия · 4 центра

• Uni Berlin Chartie Derma — Berlin
• Rosenpark Research — Darmstadt
• Uni Leipzig Derma — Leipzig
• Dermatologischen Gemeinschaftspraxis Dres. Quist — Mainz

Идентификаторы

NCT: NCT07236099 · ICP-CL-00609

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗