ICP-322
DrugICP-322 Tablets
NCT Number: NCT07236099
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
The Second Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Willingness to avoid pregnancy or fathering children
Exclusion criteria
ICP-322 Tablets
ICP-332 Placebo Tablets
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'.
Time frame: Baseline through week 40
Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time
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
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
Time frame: Baseline through week 40
Time frame: Baseline through week 40
Maximum concentration (Cmax) of ICP-322
Time frame: Baseline through week 40
Area Under Concentration Versus Time Curve (AUC) of ICP-322
Contact information is provided by the study sponsor or research team.
Beijing InnoCare Pharma Tech Co., Ltd.
Industry
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
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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