Table of contents
- Trial overview
- Who can participate
- What is being studied
- Trial phase and design
- Outcomes and endpoints
- Trial status and size
Trial overview
The available study of SAR445399 is an interventional clinical trial in adults with moderate to severe hidradenitis suppurativa.[1]
The trial title says it is designed to investigate efficacy and safety with SAR445399 in this patient group.[1]
Who can participate
This study is for adult participants who have moderate to severe hidradenitis suppurativa.[1]
Hidradenitis suppurativa is the condition being studied, and the trial focuses on people whose disease is not mild.[1]
What is being studied
The brief summary says the study aims to evaluate the efficacy of different doses of SAR445399 in participants with moderate to severe hidradenitis suppurativa.[1]
In simple words, the researchers want to see whether different doses help the condition and how well the treatment is tolerated in the study setting.[1]
Trial phase and design
This study is in Phase 2, which is a stage of research that usually looks more closely at whether a treatment works and continues to check safety.[1]
The study type is interventional, meaning participants receive the treatment being tested rather than only being observed.[1]
Outcomes and endpoints
The main outcome described in the source data is efficacy, which means how well SAR445399 works for moderate to severe hidradenitis suppurativa.[1]
Safety is also part of the study aim, so the trial is also meant to gather information about how the treatment performs in participants.[1]
The source does not list detailed endpoint measures, so only the stated goals can be confirmed from the trial data.[1]
Trial status and size
The trial status is Authorised, which means the study has been approved to move forward in the setting described by the source data.[1]
The planned enrollment is 206 participants.[1]
This makes it a mid-sized Phase 2 study focused on a specific adult patient group with hidradenitis suppurativa.[1]