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SALICYLIC ACID

Clinical trials in the provided data are investigating SALICYLIC ACID-related study records in adults and adolescents with moderate to severe hidradenitis suppurativa. These trials are looking at efficacy, safety, and tolerability, and they measure how many patients reach a clinical response after 16 weeks.

Table of Contents

Trial overview

The provided data include 2 clinical trials that are both Phase 3 and both are listed as Authorised.[1][2]

Both studies are looking at patients with hidradenitis suppurativa (HS), which is the condition named in the source data.[1][2]

Who is being studied

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

This means the trials are not for mild disease in the provided data, but for people with a more serious form of HS.[1][2]

Treatments and comparators

The intervention lists include LOU064, placebo to remibrutinib (LOU064), clindamycin, and triamcinolone.[1][2]

The source data also include entries marked as oral use and intralesional use, which means one treatment is given by mouth and another is given directly into a lesion, or skin spot.[1][2]

Because the data list several interventions, these trials appear to compare the study treatment against placebo and other listed treatments within the trial design.[1][2]

Study design and phase

Both studies are described as interventional, which means researchers assign treatments to participants and then measure the results.[1][2]

Both are Phase 3 trials, a later stage of research that usually involves larger groups of patients and focuses on how well a treatment works in real study settings.[1][2]

Endpoints and outcome measures

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

HiSCR50 means at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count, with no increase in the number of abscesses and no increase in draining tunnels or fistulae compared with baseline, which is the starting point before treatment.[1][2]

This endpoint is used to show whether the treatment helps people improve in a meaningful way after 16 weeks.[1][2]

What the trials aim to show

The brief summaries say the goal is to demonstrate the efficacy of remibrutinib compared with placebo with respect to HiSCR50 after 16 weeks of treatment.[1][2]

In simple terms, the studies want to learn whether the treatment helps more patients reach the defined response than placebo does.[1][2]

Trial status and size

One trial has an enrollment target of 532 participants, and the other has an enrollment target of 487 participants.[1][2]

Both trials are currently listed as Authorised in the source data.[1][2]

Trial IDPhaseCondition studiedStatusEnrollmentMain endpoint
2024-513266-19-00Phase 3Hidradenitis Suppurativa (HS)Authorised532HiSCR50 at Week 16
NCT06799000Phase 3Hidradenitis Suppurativa (HS)Authorised487HiSCR50 at Week 16

FAQ

  • What condition are the SALICYLIC ACID clinical trials studying? The trials in the provided data are studying hidradenitis suppurativa, also called HS. This is a long-term skin condition that causes painful lumps, abscesses, and draining tunnels.
  • Who can take part in these trials? The studies are for adult and adolescent patients with moderate to severe hidradenitis suppurativa. The trial data do not give more detailed entry rules.
  • What phase are these trials? Both studies are Phase 3 trials. Phase 3 means the treatment is being tested in a larger group of patients to better understand how well it works and how safe it is.
  • What are the trials trying to measure? The main goal is to see whether patients achieve HiSCR50 at Week 16. HiSCR50 means at least a 50% drop in abscess and inflammatory nodule count, with no increase in abscesses or draining tunnels/fistulae.
  • How many studies are included in the data? There are 2 authorized interventional studies listed. One has 532 participants and the other has 487 participants.

Ongoing Clinical Trials on SALICYLIC ACID

  • Study on the Effects of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

    Not recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Denmark Germany Greece Italy Poland +3

  • Study on the Effectiveness and Safety of Remibrutinib for Adults with Moderate to Severe Hidradenitis Suppurativa

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4

Glossary

  • Hidradenitis suppurativa (HS): A chronic skin disease that can cause painful lumps, abscesses, and draining tunnels under the skin.
  • Moderate to severe: A level of disease that is more than mild and can cause a greater number of symptoms or a bigger impact on daily life.
  • Adult and adolescent patients: The study population includes both grown-up patients and teenagers.
  • Phase 3: A later stage of clinical research that tests a treatment in a larger group of people to learn more about benefit and safety.
  • Interventional study: A trial where researchers give a treatment or placebo and compare results.
  • Placebo: A look-alike treatment that does not contain the active study medicine, used for comparison.
  • Efficacy: How well a treatment works.
  • Safety: How well a treatment is tolerated and whether it causes problems.
  • Tolerability: How manageable a treatment is for patients.
  • HiSCR50: A treatment response measure meaning at least a 50% reduction in abscess and inflammatory nodule count, with no increase in abscesses or draining tunnels/fistulae.
  • Abscess: A swollen pocket of pus.
  • Inflammatory nodule: A firm, inflamed lump under the skin.

References