Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- What the trial is trying to learn
- Key terms explained
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 people with prurigo nodularis, a condition with severe itching and skin nodules. The study is authorised and plans to enroll 135 participants.[1]
The study title says it is a randomized, double-blind, placebo-controlled, and dose-ranging phase 2 trial. In simple words, participants are assigned by chance, neither the participants nor the study team know who gets which treatment, and the trial compares the study drug with a placebo while checking more than one dose.[1]
Who can participate
The source data say the trial is for adult participants with prurigo nodularis.[1] No other eligibility details are provided in the trial record, so the available information does not list extra requirements such as past treatments, disease severity, or other health conditions.
Adults only: The study is not described as open to children or teenagers.[1]
Specific condition: Participants must have prurigo nodularis, because that is the condition being studied.[1]
Study design and phase
This is a phase 2 study, which usually means researchers are looking for early signs that the treatment may help, while still watching safety closely.[1] The trial is also placebo-controlled, so the study drug is compared with a treatment that looks the same but does not contain the active substance.[1]
The study is dose-ranging, which means more than one dose is being evaluated. The intervention list mentions 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 Peak pruritus-numeric rate scale (PP NRS) at Week 16.[1] In patient-friendly language, this means the study is checking how much the worst itching score changes after treatment compared with the starting point.
Because the endpoint focuses on itch, the trial is mainly trying to learn whether the treatment can reduce itching in people with prurigo nodularis.[1]
What the trial is trying to learn
The brief summary says the study aims to evaluate the treatment efficacy of ICP-332 versus placebo in adult participants with PN.[1] ICP-332 is the study name used in the trial title 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.[1]
From the source data, the key goals are to compare the study drug with placebo, look at different doses, and measure whether itching improves by Week 16.[1] The record also shows that safety is part of the study title, so safety is being assessed along with efficacy.[1]
Key terms explained
Randomized means treatment is assigned by chance, which helps make the comparison fair.[1] Double-blind means neither the participants nor the study team know who is receiving the active treatment or placebo during the study.[1]
Placebo means a look-alike treatment with no active substance, used to help show whether the study drug works better than no active treatment.[1] Baseline means the starting measurement before treatment begins.[1]
Primary outcome means the main result the researchers plan to measure first.[1] Enrollment means the number of people planned for the study, which here is 135.[1]
