Table of contents
Trial overview
The clinical trial for INF904 studied people with moderate to severe chronic spontaneous urticaria (CSU) or moderate to severe hidradenitis suppurativa (HS).[1] The study was designed to look at safety and pharmacokinetics, which means how the body handles the study drug over time.[1]
This was an interventional study, so participants received the study treatment and researchers measured the results.[1] It was also an open-label basket study, meaning the treatment was known to both the researchers and the participants, and the same study included more than one patient group.[1]
Study design and phase
The trial was a Phase 2 study.[1] Phase 2 trials usually focus on safety and early signs of benefit in a specific group of patients, which fits the goal of this study.[1]
Participants received INF904 by mouth, which is called oral treatment.[1] The brief summary says the study looked at safety after multiple oral doses in subjects with CSU or HS.[1]
Who could participate
The study targeted subjects with moderate to severe chronic spontaneous urticaria or moderate to severe hidradenitis suppurativa.[1] These are long-lasting conditions that can cause major symptoms and affect daily life.
People with CSU had a skin condition with hives that come and go without a clear trigger.[1]
People with HS had a long-term inflammatory skin disease, and the study focused on those with moderate to severe disease.[1]
What was measured
The main outcome was the frequency, severity, and relatedness of treatment-emergent adverse events and serious adverse events using MedDRA classification.[1] In simple terms, the study tracked new medical problems that started or got worse after treatment began, and it also tracked whether those problems were serious.[1]
The study also evaluated pharmacokinetics, which helps researchers understand how the body absorbs, processes, and removes INF904.[1]
Study status and size
The trial is marked as completed, so the planned study activities have already finished.[1] The enrollment was 75 participants.[1]
Only one trial record was provided, so the current clinical trial picture for INF904 in the source data is limited to this Phase 2 study in CSU and HS.[1]
