Trials Sponsors Conditions Drugs Pricing

Conditions

Prurigo Nodularis Prurigo Nodularis (PN)

Outcome Measures

Primary Outcomes (1)

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'.
Baseline to week 16

Secondary Outcomes (6)

Improvement in PP NRS score
Baseline through week 40
Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)
Baseline through week 40
Dermatology Life Quality Index (DLQI)
Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Baseline through week 40
Maximum concentration (Cmax)
Baseline through week 40
+1 more secondary outcomes

Study Arms (3)

ICP-332 80mg

EXPERIMENTAL

Drug: ICP-322

ICP-332 120mg

EXPERIMENTAL

Drug: ICP-322

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ICP-322Drug

ICP-322 Tablets

ICP-332 120mgICP-332 80mg

PlaceboDrug

ICP-332 Placebo Tablets

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Innocare Pharma Inc.
Industrylead
Beijing InnoCare Pharma Tech Co., Ltd.
Industrylead

Study Sites (43)

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, 35244, United States

RECRUITING

Vlada GroysmanCONTACT

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

RECRUITING

Lindsay AckermanCONTACT

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

RECRUITING

Central Study Contacts

Alexia Lu

CONTACT

+86-010-66609745 CO_HGRAC@innocarepharma.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 27, 2025

First Posted

November 19, 2025

Study Start

November 27, 2025

Actual (reported)

Primary Completion

March 2027

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

ICP-332 80mg

ICP-332 120mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

ICP-332 80mg

ICP-332 120mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (43)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations