Clinical Trial: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: EvasayilTM : A Placebo-controlled Trial to Evaluate the Efficacy and Safety of Spesolimab in the Treatment of Patients With Netherton Syndrome

Brief 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 and 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 about 1 year.
During this time, they visit the study site 16 times.
Where possible, 4 of 16 visits can be done at the participant's home instead of the study site.
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.

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Ichthyosis Area Severity Index (IASI) response is defined as a decrease of at least 50 % absolute change in IASI score from baseline at Week 16.

Original Primary Outcome: Ichthyosis Area Severity Index (IASI) response is defined as a decrease of at least 50 % absolute change in IASI score from baseline at Week 16.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boehringer Ingelheim

Dates:
Date Received: April 26, 2023
Date Started: May 15, 2023
Date Completion: May 15, 2023
Last Updated: December 11, 2023
Last Verified: December 01, 2023