BridgeMD
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of ICP-332 in Participants with Prurigo Nodularis
EU CTIS ID: 2025-523404-74-00
What this study is testing
Evaluate the treatment efficacy of ICP-332 versus placebo in adult participants with PN.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntarily sign informed consent forms before any investigational procedure(s) are performed
- Willingness to avoid pregnancy or fathering children
- 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.
You likely can't join if
- 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
- 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.
See the full eligibility criteria
Who can join
- Voluntarily sign informed consent forms before any investigational procedure(s) are performed
- Willingness to avoid pregnancy or fathering children
- 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.
What rules you out
- 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
- 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
- History of substance and/or alcohol abuse.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.