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
Peak 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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Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, United States
RECRUITINGMedical Dermatology Specialists
Phoenix, Arizona, United States
RECRUITINGCenter for Dermatology Clinical Research, Inc.
Fremont, California, United States
RECRUITINGDriven Research, LLC
Miami, Florida, United States
RECRUITINGCordova Research Institute
Sweetwater, Florida, United States
RECRUITINGDawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States
RECRUITINGOakland Hills Dermatology
Auburn Hills, Michigan, United States
RECRUITINGThe Derm Institute of West Michigan
Caledonia, Michigan, United States
RECRUITINGRevival Research Institute, LLC
Troy, Michigan, United States
RECRUITINGMinnesota Clinical Study Center
New Brighton, Minnesota, United States
RECRUITING...and 33 more locations
Area Under Concentration Versus Time Curve (AUC) of ICP-322
Time frame: Baseline through week 40