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SALICYLIC ACID

Clinical trials listed here are investigating SALICYLIC ACID in the context of hidradenitis suppurativa, a long-term skin condition. The studies are designed to assess efficacy, safety, and tolerability in adult and adolescent patients with moderate to severe disease.

Table of contents

Overview of the studies

These records describe Phase 3 clinical trials that are studying SALICYLIC ACID in people with hidradenitis suppurativa (HS).[1][2] Both trials are interventional, which means the researchers give a study treatment and then measure the results.[1][2] The studies are authorised and are focused on patients with moderate to severe disease.[1][2]

Who can participate

The target population in both trials is adult and adolescent patients with moderate to severe HS.[1][2] This means the studies are not for every person with HS, but for those who meet the trial rules and have a more serious form of the disease.[1][2]

One trial plans to enroll 532 participants, and the other plans to enroll 487 participants.[1][2] These are fairly large studies, which is common in Phase 3 research.[1][2]

What is being measured

The main endpoint in both trials is HiSCR50 at Week 16.[1][2] HiSCR50 is a study measure used in HS research and means at least a 50% decrease in the number of abscesses and inflammatory nodules, with no increase in abscesses or draining tunnels/fistulae compared with the start of the study.[1][2]

The brief study aim is to show the efficacy of the treatment compared with placebo after 16 weeks of treatment.[1][2] In patient-friendly language, the researchers want to see whether the study treatment helps skin lesions improve more than a placebo, which is a look-alike treatment with no active study drug.[1][2]

Study design and phase

Both records describe Phase 3 studies.[1][2] Phase 3 trials usually test whether a treatment works in a larger group of patients and continue to look closely at safety and tolerability.[1][2]

The trial titles and intervention lists mention remibrutinib, LOU064, placebo to remibrutinib (LOU064), clindamycin, and triamcinolone.[1][2] The source data also shows that the studies compare the active treatment with placebo and include other listed study medicines or procedures as part of the trial design.[1][2]

Trial details

The first study, 2024-513266-19-00, is an authorised Phase 3 trial with 532 planned participants.[1] Its primary outcome is HiSCR50 at Week 16.[1]

The second study, NCT06799000, is also an authorised Phase 3 trial with 487 planned participants.[2] It uses the same main endpoint, HiSCR50 at Week 16, and has the same overall goal of comparing efficacy with placebo after 16 weeks.[2]

Important patient terms

  • Placebo: a look-alike treatment used for comparison. It helps researchers see whether the study treatment works better than no active treatment.[1][2]
  • Baseline: the starting point before treatment begins. Trial results are often compared with this first measurement.[1][2]
  • Abscess and inflammatory nodule count: the number of painful skin lumps and pus-filled areas counted by the researchers.[1][2]
  • Draining tunnels/fistulae: channels under the skin that can leak fluid. The endpoint checks that these do not increase.[1][2]
  • Tolerability: how well patients can handle the treatment during the study.[1][2]
Trial ID Phase Condition studied Status Enrollment
2024-513266-19-00 Phase 3 Hidradenitis Suppurativa (HS) Authorised 532
NCT06799000 Phase 3 Hidradenitis Suppurativa (HS) Authorised 487

FAQ

  • Who can take part in these SALICYLIC ACID clinical trials? The trials are for adult and adolescent patients with moderate to severe hidradenitis suppurativa. Each study has its own eligibility rules, so not every patient with the condition can join.
  • What are the studies trying to find out? The main goal is to assess efficacy, safety, and tolerability. In simple terms, the researchers want to see whether the treatment works, how safe it is, and how well patients can tolerate it.
  • What phase are these trials? Both studies are Phase 3 trials. This means they are late-stage studies that test a treatment in a larger group of patients.
  • What condition is being studied? The condition is hidradenitis suppurativa, often shortened to HS. It is a chronic skin disease that causes painful lumps, abscesses, and draining tunnels.
  • What result are the trials measuring? The main result is HiSCR50 at Week 16. This means the researchers check whether there is at least a 50% drop in abscess and inflammatory nodule count, with no increase in abscesses or draining tunnels/fistulae.

Sperimentazioni cliniche in corso su SALICYLIC ACID

  • Studio sull’efficacia e sicurezza di Remibrutinib in pazienti adulti con idrosadenite suppurativa moderata o grave

    Arruolamento concluso

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Bulgaria Danimarca Germania Grecia Italia Polonia +3

  • Studio sull’efficacia e sicurezza di Remibrutinib in pazienti adulti con idrosadenite suppurativa moderata o grave

    Arruolamento concluso

    1 1 1 1
    Farmaci in studio:
    Austria Belgio Cechia Francia Germania Grecia +4

Glossario

  • Hidradenitis suppurativa (HS): A long-term skin disease studied in these trials. It can cause painful bumps, abscesses, and draining tunnels under the skin.
  • Adult and adolescent patients: The age groups allowed in these studies. Both older teens and adults may be included if they meet the other rules.
  • Moderate to severe: A description of how serious the disease is. Moderate to severe means the condition is not mild and causes a greater burden.
  • Phase 3: A late stage of clinical research. Phase 3 studies usually include many participants and compare treatment effects in a larger group.
  • Interventional study: A study in which researchers give a treatment or comparison treatment and then measure the results.
  • Efficacy: How well a treatment works in the study.
  • Safety: Whether the treatment causes problems or serious harm during the study.
  • Tolerability: How well patients can handle the treatment, based on the study experience.
  • HiSCR50: A study result used in hidradenitis suppurativa. It means at least a 50% decrease in abscess and inflammatory nodule count, with no increase in abscesses or draining tunnels/fistulae.
  • Abscess: A painful collection of pus under the skin.
  • Inflammatory nodule: A swollen, inflamed lump under the skin.
  • Draining tunnels/fistulae: Channels under the skin that can leak fluid. The trials check that these do not get worse.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-513266-19-00
  2. https://studi-clinici.it/studio/studio-sullefficacia-e-sicurezza-di-remibrutinib-in-pazienti-adulti-con-idrosadenite-suppurativa-moderata-o-grave/