Phase 2 Randomized Double-Blind Placebo-Controlled Dose-Ranging Study of ICP-332 in Adults with Prurigo Nodularis
- Trial ID
- 2025-523404-74-00
- Protocol
- ICP-CL-00609
- Sponsor
- Innocare Pharma Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the treatment efficacy of ICP-332 versus placebo in adults with prurigo nodularis, which is clinically relevant for determining whether the investigational treatment provides meaningful disease control. The secondary objectives are to further evaluate treatment efficacy, assess the safety and tolerability of ICP-332, and characterize its pharmacokinetic profile in adults with prurigo nodularis.
Participants
The trial enrolled 79 participants with prurigo nodularis. The study population included adult male and female participants aged 18 to 75 years at the time of informed consent. Participants were required to have a clinical diagnosis of the disease for at least 3 months, with at least 20 pruriginous lesions distributed bilaterally on the body, a PP NRS score of at least 7, and an IGA-CPG-S score of at least 3 at screening and baseline. The population was selected from patients with an inadequate response to at least topical corticosteroid therapy of medium or higher potency, or in whom topical treatment was medically inadvisable and systemic therapy was considered necessary. Additional requirements included regular use of a topical emollient once or twice daily for at least 5 of the 7 days before Day 1, willingness to avoid pregnancy or fathering children, and ability to complete a diary and comply with study restrictions and procedures. The sponsor did not provide further information on general health status, diet, physical activity, or other lifestyle characteristics.
Plans and Procedures
The study is a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging trial in adult participants with prurigo nodularis. The investigational product is administered orally and is compared with an identical placebo that contains no active substance. The trial is planned to assess efficacy, safety, and pharmacokinetics over an overall duration from 2026-05-05 to 2027-01-15. Study participation begins with a screening visit, at which eligibility is confirmed and baseline disease assessments are performed. A baseline visit on Day 1 is used to verify entry criteria and initiate study treatment. Follow-up visits occur during treatment to evaluate efficacy endpoints, adverse events, vital signs, electrocardiograms, clinical laboratory safety parameters, and pharmacokinetic measures. An end-of-study visit is performed to complete final assessments and document study completion or early discontinuation. Expected participant involvement extends through the full study period, approximately until Week 16. Early termination may occur if informed consent is withdrawn, study procedures cannot be followed, eligibility criteria are no longer met, or safety or other clinical considerations require discontinuation.
Treatment
The investigational treatment was ICP-332, administered as an oral tablet containing 120 mg of the active substance 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. Administration was by the oral route. The study was designed as a dose-ranging trial, and treatment efficacy and safety were evaluated in adult participants with prurigo nodularis.
The comparator was a placebo tablet identical in appearance to the test product and containing no active substance. The study was randomized and double-blind, and placebo served as the non-experimental treatment for comparison with ICP-332.
Efficacy
Efficacy will be assessed in adult participants with Prurigo Nodularis by the percent change from baseline in the weekly average of the Peak pruritus-numeric rate scale at Week 16. Additional efficacy assessments will include the proportion of participants achieving at least a 4-point improvement in PP NRS score over time, the proportion achieving Investigator's Global Assessment for Chronic Prurigo Stage scores of 0 or 1 over time, the proportion achieving both PP NRS improvement of at least 4 points and IGA-CPG-S scores of 0 or 1 over time, the percent change from baseline in the weekly average PP NRS over time, and the change from baseline in Dermatology Life Quality Index score over time.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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 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.
- Have applied topical emollient (moisturizer) once or twice daily for at least 5 out of the 7 consecutive days immediately before Day 1.
- Willing and able to complete a diary, abide by the study restrictions, and comply with all study procedures for the duration of the study.
- Willingness to avoid pregnancy or fathering children
Exclusion Criteria
- 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
- History of substance and/or alcohol abuse.
- Participants who are allergic to or sensitive to ingredients of the investigational drug and/or other similar products
- Planned major surgical procedure during the participant’s participation in this study.
- Pregnant or lactating women, or those planning to become pregnant during the study period.
- During the screening period prior to the first administration of the investigational drug (baseline visit), laboratory values which meet defined criteria
- 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
- 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).
- Treatment with a live (attenuated) vaccine within 4 weeks before the screening visit.
- Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.
- 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.
- 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.
- 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.
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- Any country-related specific regulation that would prevent the participant from entering the study.
- 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
- 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
- Any specific situation during study implementation/course that may raise ethics considerations.
- PN secondary to medications (e.g., opioids, angiotensin converting enzyme [ACE] inhibitors) and to medical conditions such as neuropathy or psychiatric disease
- 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.
- 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.
- 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.
- Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Participants with positive test results for defined diseases at screening
- 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.
- Having used any systemic JAK or TYK2 inhibitors within 12 weeks before the screening visit.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Austria | Recruiting | 05 May 2026 | 6 |
 Belgium | Not Yet Recruiting | 05 May 2026 | 6 |
 France | Recruiting | 05 May 2026 | 8 |
 Germany | Recruiting | 05 May 2026 | 21 |
 Poland | Recruiting | 05 May 2026 | 15 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Placebo is identical with the test product and just does not contain active substance. | Placebo | N/A | — | — | — | N/A |