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

Conditions

Prurigo Nodularis

Brief summary

Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16.

Detailed description

Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time., Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time, Proportion of participants achieving both PP NRS ≥ 4 and IGA-CPG-S 0/1 over time., Percent change from baseline of weekly average in PP NRS over time., Change from baseline in Dermatology Life Quality Index (DLQI) score over time, Safety as assessed by the nature, severity, and incidence of adverse events (AEs); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameters., PK endpoints: Cmax, AUC, etc

Related papers

No related papers found yet.

Interventions

DRUGPlacebo is identical with the test product and just does not contain active substance.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16.	—

Secondary

Measure	Time frame
Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time., Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time, Proportion of participants achieving both PP NRS ≥ 4 and IGA-CPG-S 0/1 over time., Percent change from baseline of weekly average in PP NRS over time., Change from baseline in Dermatology Life Quality Index (DLQI) score over time, Safety as assessed by the nature, severity, and incidence of adverse events (AEs); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameters., PK endpoints: Cmax, AUC, etc	—

Measure

Time frame

Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time., Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time, Proportion of participants achieving both PP NRS ≥ 4 and IGA-CPG-S 0/1 over time., Percent change from baseline of weekly average in PP NRS over time., Change from baseline in Dermatology Life Quality Index (DLQI) score over time, Safety as assessed by the nature, severity, and incidence of adverse events (AEs); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameters., PK endpoints: Cmax, AUC, etc

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Outcome results

None listed