Europas førende søgning efter kliniske forsøg

SALICYLIC ACID

Clinical trials investigating SALICYLIC ACID are described in this article, based on studies in patients with moderate to severe hidradenitis suppurativa. The trials are looking at treatment efficacy, safety, and tolerability, with a main focus on response after 16 weeks.

Table of contents

Overview of the trials

These clinical trials are studying SALICYLIC ACID in people with hidradenitis suppurativa (HS), a long-term skin disease named in the trial data.[1][2]

Both studies are looking at efficacy, safety, and tolerability, which means they want to see how well the study treatment works, how safe it is, and how well patients can handle it.[1][2]

Who can join the studies

The trials include adult and adolescent patients with moderate to severe hidradenitis suppurativa.[1][2]

This means the studies are not for mild disease, and they focus on people whose HS is serious enough to need close study.[1][2]

What is being measured

The main endpoint in both trials is HiSCR50 at Week 16.[1][2]

HiSCR50 means at least a 50% decrease in abscess and inflammatory nodule count, with no increase in abscesses and no increase in draining tunnels/fistulae compared with the start of the study.[1][2]

In simple words, the researchers want to know whether the skin disease gets clearly better after 16 weeks without new worsening in the draining areas under the skin.[1][2]

Trial design, phase, and size

Both studies are Phase 3 and interventional, which means the study treatment is given to participants and the results are compared in a planned way.[1][2]

One trial plans to include 532 participants, and the other plans to include 487 participants.[1][2]

Both studies are listed as Authorised, so they have been approved to move forward in the source data.[1][2]

Details of the two studies

The first study, 2024-513266-19-00, is a Phase 3 study in adult and adolescent patients with moderate to severe hidradenitis suppurativa.[1]

Its brief summary says the goal is to show the efficacy of remibrutinib compared with placebo for HiSCR50 after 16 weeks of treatment.[1]

The second study, NCT06799000, has the same title, phase, condition, and main endpoint, and it also aims to show efficacy compared with placebo after 16 weeks.[2]

The intervention lists in the source data include study drugs, placebo, clindamycin, and triamcinolone, but the main study question in both trials is the response to the trial treatment versus placebo.[1][2]

Medical terms explained

Placebo means a look-alike treatment with no active study drug, used to compare results fairly.[1][2]

Endpoint means the main result the researchers are measuring in the trial.[1][2]

Baseline means the start of the study, before treatment effects are measured.[1][2]

Draining tunnels/fistulae are channels under the skin that can drain fluid, and the studies track whether these get worse.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2024-513266-19-00Phase 3Hidradenitis suppurativa (HS)Authorised532
NCT06799000Phase 3Hidradenitis suppurativa (HS)Authorised487

FAQ

  • Who can take part in the SALICYLIC ACID clinical trials? The trials include adult and adolescent patients with moderate to severe hidradenitis suppurativa. Participation depends on the study rules and whether a person matches the trial criteria.
  • What condition is being studied? The trials are studying hidradenitis suppurativa, also called HS. This is the only condition named in the trial data.
  • What phase are these trials? Both trials are Phase 3 studies. Phase 3 means the treatment is being tested in a larger group to learn more about how well it works and how well it is tolerated.
  • What is the main goal of the trials? The main goal is to compare response after 16 weeks of treatment. The studies measure whether patients reach HiSCR50, which means at least a 50% drop in abscess and inflammatory nodule count without more abscesses or draining tunnels/fistulae.
  • How many studies are listed? There are 2 authorised interventional studies listed. One includes 532 participants and the other includes 487 participants.

Igangværende kliniske forsøg for SALICYLIC ACID

  • Afprøvning af lægemidlet remibrutinib til behandling af moderat til svær bylder i huden (hidradenitis suppurativa) hos voksne

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Bulgarien Danmark Tyskland Grækenland Italien Polen +3

  • Afprøvning af medicinen remibrutinib til behandling af bylder i hudfolder (hidradenitis suppurativa) hos voksne

    Rekrutterer ikke

    1 1 1 1
    Undersøgte lægemidler:
    Østrig Belgien Tjekkiet Frankrig Tyskland Grækenland +4

Ordliste

  • Hidradenitis suppurativa (HS): A long-term skin disease that causes painful lumps and inflammation. The trials study people with moderate to severe disease.
  • Moderate to severe: A description of how serious the disease is. In these studies, it means the condition is not mild.
  • Adult and adolescent patients: People who are old enough to join the study, including both adults and teenagers.
  • Phase 3: A late stage of clinical testing. It usually involves more patients and helps show how well a treatment works and how safe it is.
  • Interventional study: A study where participants receive a treatment or comparison treatment so researchers can measure the effect.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Efficacy: How well a treatment works in a study.
  • Safety: How safe a treatment is for people in the study.
  • Tolerability: How well people can handle a treatment without major problems.
  • HiSCR50: A study result that means at least a 50% decrease in abscess and inflammatory nodule count, with no increase in abscesses or draining tunnels/fistulae compared with the start of the study.
  • Abscess: A painful pocket of pus under the skin.
  • Inflammatory nodule: A swollen, inflamed lump under the skin.
  • Draining tunnels/fistulae: Channels under the skin that can drain fluid. The studies check that these do not get worse.

Referencer

  1. https://clinicaltrials.gov/study/2024-513266-19-00
  2. https://kliniske-forsoeg.dk/forsog/afprovning-af-laegemidlet-remibrutinib-til-behandling-af-moderat-til-svaer-bylder-i-huden-hidradenitis-suppurativa-hos-voksne/