Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
135
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
NOT_YET_RECRUITINGPeak pruritus-numeric rate scale (PP NRS)
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'.
Time frame: Baseline to week 16
Improvement in PP NRS score
Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time
Time frame: Baseline through week 40
Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)
Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time
Time frame: Baseline through week 40
Dermatology Life Quality Index (DLQI)
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
Time frame: Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Baseline through week 40
Maximum concentration (Cmax)
Maximum concentration (Cmax) of ICP-322
Time frame: Baseline through week 40
Area Under Concentration Versus Time Curve (AUC)
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Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGDermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGJingzhou Central Hospital
Jingzhou, Hubei, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe first hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGShenyang Seventh People's Hospital
Shenyang, Liaoning, China
NOT_YET_RECRUITING...and 5 more locations
Area Under Concentration Versus Time Curve (AUC) of ICP-322
Time frame: Baseline through week 40