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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 main goal is to see whether it helps reduce itching and to assess safety in a phase 2 study. The trial compares the study drug with placebo.

Table of contents

Overview of the trial

The available trial is studying prurigo nodularis, a skin condition with severe itching, in adults.[1] It is a phase 2 study, which means it is an early efficacy study that also keeps checking safety.[1] The trial is designed to see whether 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 can improve symptoms compared with placebo.[1]

Who can join the study

The trial data say that the study is for adult participants with prurigo nodularis.[1] No other entry details are provided in the source data, so the exact rules for joining are not listed here.[1]

Study design and treatment groups

This is an interventional study, meaning researchers give a treatment and then compare results between groups.[1] It is described as randomized, so participants are assigned to study groups by chance.[1] It is also double-blind, which means neither the participants nor the study team know who receives the study drug or placebo during the trial.[1]

The study is placebo-controlled, so one group receives placebo and the other receives 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.[1] It is also dose-ranging, which means the study is checking treatment amounts to help understand which dose may be useful.[1] The intervention list includes placebo and 120 mg oral study drug.[1]

What the study measures

The primary outcome 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 checking whether itching becomes better over 16 weeks.[1]

The source data do not list other outcomes, so the main measured result in the available information is the itch score at Week 16.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 135 participants.[1] This gives a small-to-moderate study size for an early-stage trial.[1]

Patient-friendly terms

Baseline means the starting point before treatment begins.[1] Weekly average means the score is looked at over time, not just on one day.[1] Placebo means a look-alike treatment without active substance, used for fair comparison.[1] Randomized means group assignment is done by chance.[1] Double-blind means the study is set up so expectations do not influence the results.[1]

Trial ID Phase Condition studied Status Enrollment Main outcome
NCT07236099 Phase 2 Prurigo nodularis Authorised 135 Percent change in weekly average PP NRS at Week 16

FAQ

  • What condition is being studied? The trial is studying prurigo nodularis, a skin condition linked to severe itching and itchy nodules.
  • Who can take part in the study? The study is for adult participants with prurigo nodularis. The trial data do not give more detailed entry rules.
  • What is being compared in the trial? The study compares 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 with placebo. Placebo is made to look the same but does not contain the active substance.
  • What phase is the trial? This is a phase 2 clinical trial. Phase 2 studies usually look at early signs of benefit and continue to check safety.
  • What result is the study measuring? The main result is the percent change in weekly average itch score, called the Peak pruritus-numeric rate scale, at Week 16. This shows whether itching gets better over time.

Igangværende kliniske forsøg for 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

  • Undersøgelse af ICP-332 til voksne med prurigo nodularis

    Rekrutterer

    1
    Undersøgte lægemidler:
    Østrig Belgien Frankrig Tyskland Polen

Ordliste

  • Prurigo nodularis: A skin condition with very itchy bumps or nodules. The trial is testing whether the study drug can help people with this condition.
  • Phase 2: A mid-stage clinical trial. It looks at whether a treatment may work and continues to check safety.
  • Randomized: People are put into study groups by chance. This helps make the comparison fair.
  • Double-blind: Neither the participants nor the study team know who gets the study drug or placebo during the trial. This helps prevent bias.
  • Placebo: A look-alike treatment with no active substance. It is used to compare results fairly.
  • Dose-ranging: The study checks different amounts of the treatment to see which dose may work best.
  • Efficacy: How well a treatment works for the condition being studied.
  • Safety: How well a treatment is tolerated and whether any problems appear during the study.
  • Primary outcome: The main result the trial is designed to measure.
  • Peak pruritus-numeric rate scale (PP NRS): A score used to measure itching. Higher or lower numbers show how bad the itch is.
  • Week 16: The time point 16 weeks after the start of the study when the main result is checked.
  • Interventional study: A study where participants receive a treatment or placebo so researchers can compare outcomes.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/icp-332-ved-kloende-knuder-i-huden-hos-voksne-med-prurigo-nodularis-2/