1368-0104: Efficacy and safety of spesolimab in patients with Netherton syndrome
Research type
Research Study
Full title
Evasayil : A placebo-controlled trial to evaluate the efficacy and safety of spesolimab in the treatment of patients with Netherton syndrome
IRAS ID
1007215
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years or older. The purpose of this study is to find out whether a
medicine called spesolimab helps people with NS.
Participants are divided into a spesolimab and a placebo group. Placebo injections look like spesolimab injections but do not contain any medicine. Every participant has a 2 in 3 chance of being in the spesolimab group. In the beginning, participants get the study medicine as an injection into a vein. Afterwards, they get it as an injection under the skin every month. After 4 months, participants in the placebo group switch to spesolimab treatment.
Participants are in the study for up to 3 years. During this time, they visit the study site up to42 times. The doctors regularly check participants’ NS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants’ general health and take note of any unwanted effects.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
23/EE/0070
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion