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ICP-332 for Adults with Prurigo Nodularis

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in Prurigo Nodularis, a skin condition that causes very itchy, raised bumps on the skin. The study is testing ICP-332, an oral tablet taken by mouth, and comparing it with placebo. The purpose of the study is to see whether ICP-332 is safe and helpful for adults with this condition.

People in the study are assigned by chance to receive different doses of ICP-332 or placebo. The treatment is taken over a period of time, and the study team follows participants during the trial to see how the skin condition and itching change and to watch for any side effects. The medicine being tested has the code name ICP-332 and the active substance is 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment begins
You are assigned to receive either the test medicine or placebo in a random way. Random means the treatment is chosen by chance.
The study is double-blind, which means neither you nor the study team knows which treatment you receive during the trial.
The test medicine is ICP-332, taken by mouth as a tablet at a dose of 120 mg. The placebo looks the same but does not contain active medicine.
The trial is a dose-ranging study, which means the effect and safety of the study treatment are being checked across study dosing.
Step 2
Treatment period
You take the study treatment by mouth according to the trial plan for the study period.
If you receive the test medicine, the dose is 120 mg as an oral tablet. The source data does not state a different dose, frequency, or duration for the placebo, only that it is identical in appearance and contains no active substance.
During this period, the main symptom being measured is itching. The study uses the peak pruritus-numeric rate scale (PP NRS), which is a number scale for rating the worst itching.
The study also measures skin improvement using the investigator's global assessment for chronic prurigo stage score (IGA-CPG-S). This is a doctor-rated score of how the skin condition is doing.
Your quality of life is measured with the dermatology life quality index (DLQI), which is a questionnaire about how the skin condition affects daily life.
Step 3
Week 16 assessment
At week 16, the main result is checked by comparing the percent change from baseline in the weekly average of the PP NRS. Baseline means the starting point at the beginning of the study.
The study also checks how many participants have at least a 4-point improvement in PP NRS over time.
The study checks how many participants reach IGA-CPG-S 0/1, which means the skin score is either 0 or 1, over time.
The study checks how many participants reach both PP NRS improvement of at least 4 points and IGA-CPG-S 0/1 over time.
The study also continues to measure change in DLQI over time.
Step 4
Safety and blood test monitoring
During the trial, your safety is monitored by checking the type, seriousness, and number of adverse events. Adverse events are unwanted medical problems that happen during the study.
Your vital signs are checked. Vital signs are basic body measurements such as pulse and blood pressure.
You have ecgs, which are heart tracings that show how your heart is working.
You also have clinical laboratory safety tests, which are blood or other lab tests used to check safety.
The study also includes pk measurements. pk means pharmacokinetics, which is how the body absorbs and handles the study medicine. These measurements include cmax and auc, which are study measures of medicine levels in the body over time.
Step 5
Study end
The estimated study period runs from 2026-05-05 to 2027-01-15.
At the end of the trial, the collected information on itching, skin changes, quality of life, safety, and medicine levels is reviewed as part of the study results.

Who can join the trial?

11 criteria

The person must voluntarily sign an informed consent form before any study tests or procedures are done. Informed consent means agreeing to join the study after receiving the necessary information.
The person must be willing to avoid pregnancy or fathering a child during the study, if that applies to them.
The person must be a male or female between 18 and 75 years old at the time they sign the informed consent form.
The person must have a clinical diagnosis of prurigo nodularis made by a dermatologist (a doctor who treats skin conditions) for at least 3 months before the screening visit.
The person must have at least 20 itchy skin lesions on the whole body, with spots on both sides of the body, such as on both legs, both arms, and/or the trunk (the main part of the body), at both the screening visit and the baseline visit (Day 1).
The person must have a PP NRS score of 7 or higher at both the screening visit and the baseline visit. The PP NRS is a number scale used to measure itching, with higher numbers meaning worse itching.
The person must have an IGA-CPG-S score of 3 or higher at both the screening visit and the baseline visit. This is a doctor-rated score that measures how severe the skin condition is.
The person must have had an inadequate response to at least one topical corticosteroid of medium or higher strength, or topical treatment must be considered medically unsuitable because of important side effects or safety risks. A topical corticosteroid is a steroid cream or ointment applied to the skin.
The study doctor must judge that the person needs systemic therapy. Systemic therapy means treatment that works throughout the body, not just on the skin.
The person must have used a topical emollient (a moisturizer) once or twice a day for at least 5 of the 7 days right before Day 1.
The person must be willing and able to complete a diary, follow the study rules, and carry out all study procedures for the full study period.

Who cannot join the trial?

26 criteria

People with a documented diagnosis of moderate to severe atopic dermatitis (AD) within 6 months before screening, or from screening until randomization. Atopic dermatitis is a type of eczema that causes inflamed, itchy skin.
People who are expected to use any prohibited medicines or procedures during screening or during the study treatment period.
People who have taken part in a previous study of ICP-332, have already received ICP-332, or have used a JAK inhibitor or TYK2 inhibitor before and did not respond to it. These are medicines that affect the immune system.
People who have other skin conditions besides prurigo nodularis and mild atopic dermatitis that could affect study results, such as scabies (a skin infestation caused by mites), insect bite reactions, lichen simplex chronicus (thickened skin from repeated scratching), psoriasis, acne, folliculitis (inflamed hair follicles), habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, or bullous disease (a blistering skin condition).
People who used another investigational drug recently, including investigational monoclonal antibodies or small molecules. Monoclonal antibodies are lab-made proteins, and small molecules are small drug compounds. The required waiting time before screening was not met.
People who are living in an institution because of a legal or regulatory order, including prisoners or people who are legally institutionalized.
People who cannot join the study because of country-specific rules.
People who are judged by the investigator to be unsuitable for any reason, including medical problems, clinical concerns, or a risk of not following the study rules.
Employees of the study site, other people directly involved in running the study, or their immediate family members.
Any situation during the study that raises ethical concerns.
People whose prurigo nodularis is caused by medicines such as opioids or ACE inhibitors, or caused by other medical conditions such as neuropathy (nerve damage) or a psychiatric disease.
People with a history of substance abuse or alcohol abuse.
People with any uncontrolled or serious disease, or any medical, psychological, or surgical condition, including important abnormal lab results, if this could affect study results or make study participation unsafe.
People with an active infection that needs treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before screening or during screening. A cutaneous infection, which means a skin infection, is also not allowed if it needed no systemic antibiotics within 1 week before the baseline visit.
People with known or suspected immunodeficiency, which means a weakened immune system, including a history of serious unusual infections such as TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis, or severe herpes zoster. This also includes repeated infections that suggest a weak immune system.
People with evidence of active, latent, or not adequately treated tuberculosis (TB). Latent TB means the infection is present but inactive.
People with positive screening tests for certain defined diseases.
People with an active cancer or a history of cancer within 5 years before the baseline visit, except for fully treated cancer in the cervix that was found early and fully removed, or fully treated and resolved non-spreading squamous cell or basal cell skin cancer.
People who used any systemic JAK inhibitor or TYK2 inhibitor within 12 weeks before screening.
People who are allergic to, or sensitive to, the study drug or similar products.
People who are expected to have a major surgery during the study.
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.
People whose laboratory test results during screening meet the study’s exclusion limits.
People who took a strong CYP3A inhibitor or CYP3A inducer before the first dose, or who plan to use them during the study. These are medicines, supplements, or foods that can strongly change how the body breaks down drugs. This includes grapefruit or grapefruit juice.
People who start prescription moisturizers, or moisturizers with added ingredients such as ceramide, hyaluronic acid, urea, menthol, polidocanol, or filaggrin degradation products during screening, unless they were already using a stable dose before screening.
People who had a live vaccine within 4 weeks before screening. A live vaccine contains a weakened form of a germ.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Carl Von Ossietzky Universitaet Oldenburg
Oldenburg In Holstein, Germany
Verified
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

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Investigated drugs

ICP-332 is the study medicine being tested in this trial. It is taken by mouth as a tablet and is being studied to see whether it can help reduce the itching and skin symptoms of prurigo nodularis. Researchers are also checking how safe it is and how well people tolerate it.

What is already known about the treatment

Placebo
This is an inactive tablet that looks the same as the test medicine but does not contain any active drug. It is taken by mouth in the same way as the study medicine, and it is used in clinical trials to compare results fairly and see whether the active treatment really works. Placebo has no therapeutic use in regular medicine and has no drug class or known action in the body, because it is designed to have no medical effect.
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
This medicine is given as an oral tablet, meaning it is swallowed by mouth. It is an investigational drug, so its full place in routine medical care is still being studied, but it is being tested for prurigo nodularis, a skin condition that causes very itchy, hard bumps on the skin. Based on its chemical design, it is thought to work by blocking a specific cell signal involved in inflammation and itch, which may help reduce itching and skin irritation; it belongs to the class of targeted anti-inflammatory medicines.

Investigated diseases

Prurigo Nodularis - Prurigo nodularis is a long-lasting skin disease marked by very itchy, firm bumps or nodules, often on the arms, legs, or trunk. The itching leads to repeated scratching, which can make the skin thicker, rougher, and more irritated over time. The nodules may increase in number and size as the condition continues, and new areas can become involved.