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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Innocare Pharma Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

26 May 2026 → ongoing

Decision date (initial)

2026-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Innocare Pharma Inc

External identifiers

EU CT number

2025-523404-74-00

ClinicalTrials.gov

NCT07236099

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

Evaluate the treatment efficacy of ICP-332 versus placebo in adult participants with PN.

Secondary objectives 3

1. Further evaluate the treatment efficacy of ICP-332 versus placebo in adult participants with PN.
2. Evaluate the safety and tolerability of ICP-332 in adult participants with PN
3. Evaluate the pharmacokinetic (PK) profile of ICP-332 in adult participants with PN

Conditions and MedDRA coding

Prurigo Nodularis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Voluntarily sign informed consent forms before any investigational procedure(s) are performed
2. Male or female aged between 18 and 75 years at the time of signing the informed consent.
3. Clinical diagnosis of PN by a dermatologist for at least 3 months before the Screening visit.
4. 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.
5. PP NRS score ≥ 7 at both screening and the baseline (Day 1) visits.
6. IGA-CPG-S score ≥ 3 at both the screening and the baseline (Day 1) visits.
7. 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.
8. Have applied topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.
9. Willing and able to complete a diary, abide by the study restrictions, and comply with all study procedures for the duration of the study.
10. Willingness to avoid pregnancy or fathering children

Exclusion criteria 26

1. 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
2. History of substance and/or alcohol abuse.
3. Participants who are allergic to or sensitive to ingredients of the investigational drug and/or other similar products
4. Planned major surgical procedure during the participant’s participation in this study.
5. Pregnant or lactating women, or those planning to become pregnant during the study period.
6. During the screening period prior to the first administration of the investigational drug (baseline visit), laboratory values which meet defined criteria
7. 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
8. 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).
9. Treatment with a live (attenuated) vaccine within 4 weeks before the screening visit.
10. Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.
11. 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.
12. 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.
13. 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.
14. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
15. Any country-related specific regulation that would prevent the participant from entering the study.
16. 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
17. 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
18. Any specific situation during study implementation/course that may raise ethics considerations.
19. PN secondary to medications (e.g., opioids, angiotensin converting enzyme [ACE] inhibitors) and to medical conditions such as neuropathy or psychiatric disease
20. 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.
21. 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.
22. 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.
23. Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
24. Participants with positive test results for defined diseases at screening
25. 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.
26. Having used any systemic JAK or TYK2 inhibitors within 12 weeks before the screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 7

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Innocare Pharma Inc.

Sponsor organisation

Innocare Pharma Inc.

Address

103 Carnegie Center Suite 209

City

Princeton

Postcode

08540-6235

Country

United States

Scientific contact point

Organisation

Innocare Pharma Inc.

Contact name

Lumis International

Public contact point

Organisation

Innocare Pharma Inc.

Contact name

Lumis International

Third parties 8

Locations

5 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 133 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications