In short
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.
Key points
- The provided clinical trial data include 2 authorized Phase 3 studies in adult and adolescent patients with moderate to severe hidradenitis suppurativa. Both trials are interventional and are designed to assess efficacy, safety, and tolerability after 16 weeks of treatment. The main outcome in each study is HiSCR50, which measures whether abscesses and inflammatory nodules improve by at least 50% without worsening draining tunnels or fistulae. One study plans to enroll 532 participants, and the other plans to enroll 487 participants. The trials compare study treatment with placebo and include other listed treatments in the intervention records.
Trial overview
The provided data include 2 clinical trials that are both Phase 3 and both are listed as Authorised.
Both studies are looking at patients with hidradenitis suppurativa (HS), which is the condition named in the source data.
Who is being studied
The studies include adult and adolescent patients with moderate to severe hidradenitis suppurativa.
This means the trials are not for mild disease in the provided data, but for people with a more serious form of HS.
Treatments and comparators
The intervention lists include LOU064, placebo to remibrutinib (LOU064), clindamycin, and triamcinolone.
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.
Because the data list several interventions, these trials appear to compare the study treatment against placebo and other listed treatments within the trial design.
Study design and phase
Both studies are described as interventional, which means researchers assign treatments to participants and then measure the results.
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.
Endpoints and outcome measures
The main endpoint in both studies is HiSCR50 at Week 16.
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.
This endpoint is used to show whether the treatment helps people improve in a meaningful way after 16 weeks.
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.
In simple terms, the studies want to learn whether the treatment helps more patients reach the defined response than placebo does.
Trial status and size
One trial has an enrollment target of 532 participants, and the other has an enrollment target of 487 participants.
Both trials are currently listed as Authorised in the source data.