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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

Clinical trials are studying 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 in adults with prurigo nodularis. The trial data focus on safety, efficacy, and dose finding, with comparison against placebo. This article summarizes the study design, target population, phase, and main outcome measure.

Table of contents

Trial overview

The available trial data describe one interventional study of 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 in prurigo nodularis, a condition with severe itching and skin nodules.[1]

The study brief says the goal is to evaluate treatment efficacy of ICP-332 versus placebo in adult participants with PN.[1]

Who can participate

The trial is for adult participants with prurigo nodularis.[1]

No other eligibility details are provided in the trial record, so the available data do not list extra requirements such as prior treatments, severity limits, or other health conditions.[1]

Study design and phase

This is a Phase 2 study, which usually means the research is checking whether the treatment may help and continuing to watch safety.[1]

The trial is described as randomized, double-blind, placebo-controlled, and dose-ranging.[1]

Randomized means participants are assigned by chance to treatment groups, double-blind means neither participants nor the study team know who gets which treatment, placebo-controlled means the study compares the active treatment with an inactive look-alike, and dose-ranging means more than one dose is being explored.[1]

The intervention list shows placebo and 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 given orally at 120 mg.[1]

What is being measured

The main endpoint is the percent change from baseline in the weekly average of the Peak pruritus-numeric rate scale (PP NRS) at Week 16.[1]

In simple words, the study is measuring how much itching changes after treatment compared with the starting point, using a score designed to track itch severity.[1]

Trial status and size

The trial status is Authorised, and the planned enrollment is 135 participants.[1]

This gives a clear picture of a mid-stage study in a defined adult population with prurigo nodularis, focused on whether the treatment can reduce itching better than placebo.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07236099 Phase 2 Prurigo Nodularis Authorised 135

FAQ

  • What condition is being studied with 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 trial is in people with prurigo nodularis. This is the only condition listed in the trial data.
  • Who can take part in the study? The study brief says it is for adult participants with prurigo nodularis. No other eligibility details are provided in the trial data.
  • What kind of trial is it? It is a Phase 2 interventional study. It is also randomized, double-blind, placebo-controlled, and dose-ranging, which means it tests different doses and compares them with placebo without participants or researchers knowing who gets which treatment.
  • What is the main goal of the trial? The main goal is to evaluate treatment efficacy and safety of ICP-332 versus placebo in adults with prurigo nodularis. The trial also looks at how different doses perform.
  • What outcome is being measured? The main outcome is the percent change from baseline in the weekly average of the Peak pruritus-numeric rate scale at Week 16. This measures how much itching changes over time.

Sperimentazioni cliniche in corso su 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

  • Studio di fase 2 su ICP-332 per adulti con prurigo nodulare

    In arruolamento

    1
    Farmaci in studio:
    Austria Belgio Francia Germania Polonia

Glossario

  • Prurigo nodularis: A skin condition with very itchy bumps or nodules. The trial is studying adults who have this condition.
  • Phase 2: A stage of clinical research that usually looks at whether a treatment may work and continues to monitor safety.
  • Randomized: Study participants are assigned by chance to different treatment groups. This helps make the groups fair to compare.
  • Double-blind: Neither the participant nor the study team knows who is receiving the study drug or placebo during the trial.
  • Placebo: A look-alike treatment that does not contain the active substance. It is used to compare results fairly.
  • Dose-ranging: A study design that tests more than one dose to see which amount may work best.
  • Interventional study: A clinical trial where researchers give a treatment and then measure the results.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: Information about how well a treatment is tolerated and whether it causes problems in the study.
  • Primary outcome: The main result the study is designed to measure.
  • Peak pruritus-numeric rate scale (PP NRS): A score used to measure itching. Higher or lower numbers show how strong the itching is.
  • Baseline: The starting point before treatment begins, used for comparison later in the study.