In short
Clinical trials are studying INF904 in people with moderate to severe chronic spontaneous urticaria (CSU) or hidradenitis suppurativa (HS). The main goal is to assess safety and pharmacokinetics, which means how the body handles the study drug over time. These studies help researchers understand INF904 in specific patient groups.
Key points
- Clinical trials of INF904 are studying people with moderate to severe chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The available study is a Phase 2, open-label, basket trial. It is designed to evaluate safety and pharmacokinetics after multiple oral doses. The main outcomes include treatment-emergent adverse events and serious adverse events. The trial has been completed and enrolled 75 participants.
Trial overview
The clinical trial for INF904 studied people with moderate to severe chronic spontaneous urticaria (CSU) or moderate to severe hidradenitis suppurativa (HS). The study was designed to look at safety and pharmacokinetics, which means how the body handles the study drug over time.
This was an interventional study, so participants received the study treatment and researchers measured the results. 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.
Study design and phase
The trial was a Phase 2 study. 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.
Participants received INF904 by mouth, which is called oral treatment. The brief summary says the study looked at safety after multiple oral doses in subjects with CSU or HS.
Who could participate
The study targeted subjects with moderate to severe chronic spontaneous urticaria or moderate to severe hidradenitis suppurativa. 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.
- People with HS had a long-term inflammatory skin disease, and the study focused on those with moderate to severe disease.
What was measured
The main outcome was the frequency, severity, and relatedness of treatment-emergent adverse events and serious adverse events using MedDRA classification. 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.
The study also evaluated pharmacokinetics, which helps researchers understand how the body absorbs, processes, and removes INF904.
Study status and size
The trial is marked as completed, so the planned study activities have already finished. The enrollment was 75 participants.
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.