3-[(3AS,6AR)-5-{5-CHLORO-2-[(1-METHYL-1H-PYRAZOL-4-YL)AMINO]PYRIMIDIN-4-YL}-3A-METHYLHEXAHYDROPYRROLO[3,4-C]PYRROL-2(1H)-YL]-3-OXOPROPANENITRILE for Prurigo nodularis

Inclusion criteria

• {"criterion_text":"- Voluntarily sign informed consent forms before any investigational procedure(s) are performed"}
• {"criterion_text":"- Willingness to avoid pregnancy or fathering children"}
• {"criterion_text":"- Male or female aged between 18 and 75 years at the time of signing the informed consent."}
• {"criterion_text":"- Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits."}
• {"criterion_text":"- IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits."}
• {"criterion_text":"- History of inadequate response to at least 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), and, in the investigator‘s judgment, the participant requires systemic therapy."}
• {"criterion_text":"- Have applied topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1."}
• {"criterion_text":"- Willing and able to complete a diary, abide by the study restrictions, and comply with all study procedures for the duration of the study."}

Exclusion criteria

• {"criterion_text":"- Participants with a documented AD severity moderate to severe within 6 months before the screening visit, or documented diagnosis of moderate to severe AD from screening visit to randomization visit"}
• {"criterion_text":"- History of substance and/or alcohol abuse."}
• {"criterion_text":"- Participants who are allergic to or sensitive to ingredients of the investigational drug and/or other similar products"}
• {"criterion_text":"- Planned major surgical procedure during the participant’s participation in this study."}
• {"criterion_text":"- Pregnant or lactating women, or those planning to become pregnant during the study period."}
• {"criterion_text":"- During the screening period prior to the first administration of the investigational drug (baseline visit), laboratory values which meet defined criteria"}
• {"criterion_text":"- Have taken strong CYP3A inhibitors or inducers (including Western medications, traditional Chinese medicines, and dietary supplements) within 5 elimination half-lives (if documented pharmacokinetic data are available) or 28 days (whichever is longer) prior to the first dose; or planned concomitant use of drugs, dietary supplements, or foods with strong CYP3A inhibitory/inducing effects (e.g., grapefruit/grapefruit juice) during study period"}
• {"criterion_text":"- Initiation of treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, menthol, polidocanol, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the Screening visit)."}
• {"criterion_text":"- Treatment with a live (attenuated) vaccine within 4 weeks before the screening visit."}
• {"criterion_text":"- Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period."}
• {"criterion_text":"- Participation in any prior clinical study of ICP-332; previous treatment with ICP-332; or prior use of any JAK or TYK2 inhibitor to which the participant was non-responsive."}
• {"criterion_text":"- Presence of skin morbidities other than PN and mild AD that may interfere with the assessment of the study outcomes. Conditions such as, but not limited to, the following: scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease."}
• {"criterion_text":"- Exposure to another systemic or topical investigative drug (monoclonal antibodies as well as small molecules) within a certain time period prior to screening, as follows: an interval of less than 6 months or <5 PK half-lives for investigative monoclonal antibodies, whichever is longer, and an interval of less than 30 days or <5 PK half-lives, whichever is longer, for investigative small molecules."}
• {"criterion_text":"- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized."}
• {"criterion_text":"- Any country-related specific regulation that would prevent the participant from entering the study."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals"}
• {"criterion_text":"- Any specific situation during study implementation/course that may raise ethics considerations."}
• {"criterion_text":"- PN secondary to medications (e.g., opioids, angiotensin converting enzyme [ACE] inhibitors) and to medical conditions such as neuropathy or psychiatric disease"}
• {"criterion_text":"- 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 participant’s participation in the study."}
• {"criterion_text":"- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening visit or during the screening period. Cutaneous infection without systemic antibiotics within 1 week before the baseline visit."}
• {"criterion_text":"- Known or suspected immunodeficiency, including history of invasive opportunistic infections (e.g., TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, and herpes zoster (disseminated; ophthalmic; encephalitis; involvement of 2 or more dermatomes; recurrence >1) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the investigator."}
• {"criterion_text":"- Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)"}
• {"criterion_text":"- Participants with positive test results for defined diseases at screening"}
• {"criterion_text":"- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin."}
• {"criterion_text":"- Having used any systemic JAK or TYK2 inhibitors within 12 weeks before the screening visit."}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline of weekly average in Peak pruritus-numeric rate scale (PP NRS) at Week 16.","definition_or_measurement_approach":"Percent change from baseline of the weekly average Peak Pruritus Numerical Rating Scale (PP NRS) score at Week 16 (measured as percent change from baseline in weekly average PP NRS)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants achieving ≥ 4-point improvement in PP NRS score (PP NRS ≥ 4) over time.","definition_or_measurement_approach":"Proportion of participants achieving a ≥4-point improvement in PP NRS from baseline over time."}
• {"endpoint_text":"- Proportion of participants achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 (IGA-CPG-S 0/1) over time","definition_or_measurement_approach":"Proportion of participants achieving IGA-CPG-S score of 0 or 1 over time."}
• {"endpoint_text":"- Proportion of participants achieving both PP NRS ≥ 4 and IGA-CPG-S 0/1 over time.","definition_or_measurement_approach":"Proportion of participants meeting both PP NRS ≥4 improvement and IGA-CPG-S 0/1 over time."}
• {"endpoint_text":"- Percent change from baseline of weekly average in PP NRS over time.","definition_or_measurement_approach":"Percent change from baseline of the weekly average PP NRS measured at scheduled timepoints over the study period."}
• {"endpoint_text":"- Change from baseline in Dermatology Life Quality Index (DLQI) score over time","definition_or_measurement_approach":"Change from baseline in DLQI score measured at scheduled timepoints over the study period."}
• {"endpoint_text":"- Safety as assessed by the nature, severity, and incidence of adverse events (AEs); vital signs; electrocardiograms (ECGs); and clinical laboratory safety parameters.","definition_or_measurement_approach":"Safety assessed by recording AEs (nature, severity, incidence), vital signs, ECGs and laboratory safety parameters per protocol."}
• {"endpoint_text":"- PK endpoints: Cmax, AUC, etc","definition_or_measurement_approach":"Pharmacokinetic endpoints including Cmax, AUC and other standard PK parameters."}

Methods

• Social media wording/documents (country-specific social media wording files present for DE, PL, FR, NL) — use of social media advertisements and wording (recruitment arrangements).
• SEA (Search Engine Advertising) wording documents (country-specific) — online paid search advertising.
• Referral letters (country-specific) — clinic-to-clinic or HCP referral outreach.
• Pre-screening wording documents (country-specific) — materials to facilitate pre-screening contact.
• Posters and Poster master (country-specific) — site posters for recruitment.
• Landing page wording (country-specific) — dedicated landing pages for recruitment.
• Flyers and Flyer master (country-specific) — printed recruitment flyers.
• Images Advertisement Master and Images files (EN) — digital/graphic ads for recruitment.
• Subject Participation Card (country-specific) — card provided to participants.
• Recruitment informed consent materials (K1) — materials used in recruitment/consent processes.

Germany

Earliest CTIS Part Ii Submission Date

30-04-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

15

Number Of Sites

9

Number Of Participants

21

Poland

Earliest CTIS Part Ii Submission Date

04-05-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

11

Number Of Sites

12

Number Of Participants

15

Belgium

Earliest CTIS Part Ii Submission Date

20-04-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

23

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Innocare Pharma Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Safety Testing, PD Testing; contact yuntong.zhang@iconplc.com

Name

MARKEN Germany GmbH

Responsibilities

Logistics/support role (sponsor duty code 14); contact Bruce.Lai@marken.com

Name

Hangzhou Tigermed Consulting Co. Ltd.

Responsibilities

Country CRO/operational support (sponsor duty code 8); contact RA_EU@tigermedgrp.com

Name

Symbio Clinical Research GmbH

Responsibilities

Multiple study support roles (sponsor duty codes 1,11,12,2); contact information@symbioresearch.com

Name

Bioclinica Shanghai Co. Ltd.

Responsibilities

eCOA provider; contact support@clario.com

Name

United-Power Pharma Tech Co. Ltd.

Responsibilities

PK Testing; contact kellydong@up-pharma.com

Name

Productlife Limited

Responsibilities

Regulatory/other support (sponsor duty code 8); contact dstojsic@productlife-group.com

Name

Guangdong Janus Medical Technology Co. Ltd.

Responsibilities

Various operational roles (sponsor duty codes 10,3,6,7); contact contact@q2bi.com

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Safety Testing, PD Testing; sponsor duty code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"sponsor duty code 14","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Hangzhou Tigermed Consulting Co. Ltd.","duties_or_roles":"sponsor duty code 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"Sponsor duties codes: 1, 11, 12, 2","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"United-Power Pharma Tech Co. Ltd.","duties_or_roles":"PK Testing","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Guangdong Janus Medical Technology Co. Ltd.","duties_or_roles":"Sponsor duties codes: 10, 3, 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Bioclinica Shanghai Co. Ltd.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Productlife Limited","duties_or_roles":"Sponsor duty code 8","organisation_type":"Pharmaceutical company"}