Prurigo Nodularis (PN)Phase 2NCT07236099
Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
A Phase 2 study testing ICP-322 in people with Prurigo Nodularis (PN), run by Beijing InnoCare Pharma Tech Co., Ltd. at 43 sites in 5 countries.
Trial summary
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prurigo Nodularis (PN)
- What is being tested?
- ICP-322
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 27 Nov 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
- At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
- PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
- IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
- History of inadequate response to topical corticosteroid of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
- Willingness to avoid pregnancy or fathering children
Who cannot join
- Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
- Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Trial locations and contacts
43 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 5 countries
China15 sites, 15 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianzhong Zhang
Cheng Zhou
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Shanshan Li
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Juan Su
- Recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610021
Yanyan Feng
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Lixia Zhang
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Tao Cai
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Niu Xiang
- Recruiting
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091
Xiaohua Wang
- Recruiting
Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University
Hangzhou, Zhejiang, 250022
Liming Wu
- Recruiting
Shandong Provincial Dermatology Hospital
Jinan, Shandong, 250022
Furen Zhang
- Recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yi Sun
- Recruiting
Shenyang Seventh People's Hospital
Shenyang, Liaoning, 110003
Zhen Wang
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Guoqiang Zhang
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300131
Litao Zhang
Yan Xu
- Recruiting
The Second Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, 241000
Ruzhi Zhang
United States14 sites, 14 recruiting
- Recruiting
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Christopher Buatti
- Recruiting
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Vlada Groysman
- Recruiting
The Derm Institute of West Michigan
Caledonia, Michigan, 49316
Kristi Hawley
- Recruiting
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Sunil S Dhawan
- Recruiting
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, 46250
Kenneth W. Dawes
- Recruiting
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
Jorge A Garcia-Zuazaga
- Recruiting
Driven Research, LLC
Miami, Florida, 33126
Javier Alonso-Llamazares
- Recruiting
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Christina Feser
- Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Steven Kempers
- Recruiting
Skin Specialists, PC
Omaha, Nebraska, 68144
Joel Schlessinger
- Recruiting
Medical Dermatology Specialists
Phoenix, Arizona, 85006
Lindsay Ackerman
- Recruiting
StracSkin, PLLC
Portsmouth, New Hampshire, 03801
Abel Jarell
- Recruiting
Cordova Research Institute
Sweetwater, Florida, 33182
Maria Cartaya
- Recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
Ali Moiin
Poland9 sites, 9 recruiting
- Recruiting
Specderm Poznanska
Bialystok, 15-375
Maria Poznanska
- Recruiting
AKK MEDlCAL Spółka z ograniczoną Odpowiedzialnością, Centrum Medyczne Tu się Leczy
Gdansk, 80-280
lzABELA KARAMoN
- Recruiting
Zdybski Ned SP.Z.O.O
Kielce, 25-553
Jacek Zdybski
- Recruiting
Amicare Centrum Medyczne
Lodz, 91-495
Aleksandra Bala-Wojsznis
- Recruiting
Centrum Badawcze Panaceum
Malbork, 82-200
Anna Sobiezek-Kundro
- Recruiting
Twoja Przychodnia
Nowa Sól, 67-100
Anna Kacalak-Rzepka
- Recruiting
Twoja Przychodnia Centrum Medyczne
Poznan, 60-324
Leszek Bartoszak
- Recruiting
Uniwersytecki Szpital Kliniczny
Rzeszów, 35-055
Adam Reich
- Recruiting
Klinika Ambroziak Dermatologia
Warsaw, 25-553
Monika Kalowska
Germany4 sites, 4 recruiting
- Recruiting
Uni Berlin Chartie Derma
Berlin, 12203
Martin Metz
- Recruiting
Rosenpark Research
Darmstadt, 64283
Oliver Weirich
- Recruiting
Uni Leipzig Derma
Leipzig, 04103
Jan-Christoph Simon
- Recruiting
Dermatologischen Gemeinschaftspraxis Dres. Quist
Mainz, 55128
Seven Quist
France1 site, 1 recruiting
- Recruiting
Chu de Brest - Hopital Morvan
Brest, 29690
Laurent Misery
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
- Conditions
- Prurigo Nodularis (PN)
- Being tested
- ICP-322, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-322Drug
ICP-322 Tablets
PlaceboDrug
ICP-332 Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| ICP-332 80mg | Experimental | Not described Receives: Drug: ICP-322 |
| ICP-332 120mg | Experimental | Not described Receives: Drug: ICP-322 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: Baseline to week 16
Secondary outcomes (6)
Improvement in PP NRS score
Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time
Measured: 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
Measured: 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
Measured: Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: Baseline through week 40
Maximum concentration (Cmax)
Maximum concentration (Cmax) of ICP-322
Measured: Baseline through week 40
Area Under Concentration Versus Time Curve (AUC)
Area Under Concentration Versus Time Curve (AUC) of ICP-322
Measured: Baseline through week 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start27 Nov 2025
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo Nodularis (PN)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236099
- Sponsor's protocol ID
- ICP-CL-00609
- Status last verified
- Dec 2025
- First submitted
- 27 Oct 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT07236099
- Acronym / sponsor ID
- ICP-CL-00609
- Conditions
- Prurigo Nodularis (PN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy and safety of ICP-332 in participants with Prurigo Nodularis (PN)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICP-332 80mg | Experimental | Drug: ICP-322 |
| ICP-332 120mg | Experimental | Drug: ICP-322 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
- At least 20 pruriginous lesions on the entire body with a bilateral distribution (on both legs, and/or both arms and/or trunk) at both screening and the baseline (Day 1) visits.
- PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
Key exclusion criteria (2 listed)
- Patients with a documented AD severity moderate to severe presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. PN secondary to medications .
- Any uncontrolled or serious disease, or any medical, psychological, or surgical condition including relevant laboratory abnormalities at screening that may either interfere with the interpretation of the clinical trial results and/or, in the investigator's judgment, would adversely affect the patient's participation in the study. Active chronic or acute infection participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-322ICP-322 Tablets | Drug | ICP-332 120mg, ICP-332 80mg |
| PlaceboICP-332 Placebo Tablets | Drug | Placebo |
Primary outcome
Peak pruritus-numeric rate scale (PP NRS)
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'.
6 secondary outcomes
Improvement in PP NRS score
Time frame: Baseline through week 40
Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1)
Time frame: Baseline through week 40
Dermatology Life Quality Index (DLQI)
Time frame: Baseline through week 40
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Baseline through week 40
Maximum concentration (Cmax)
Time frame: Baseline through week 40
Area Under Concentration Versus Time Curve (AUC)
Time frame: Baseline through week 40
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-322 in people with Prurigo Nodularis (PN), run by Beijing InnoCare Pharma Tech Co., Ltd. at 43 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in China, United States, Poland, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (+86-010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak pruritus-numeric rate scale (PP NRS) (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.