A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Status:
Recruiting
Trial end date:
2023-02-16
Target enrollment:
Participant gender:
Summary
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People
between 12 and 75 years old can take part in the study. The study is open to people who had
GPP flare-ups in the past but whose skin is clear or almost clear when they join the study.
The purpose of the study is to test 3 different doses of a medicine called spesolimab and to
see whether it helps to prevent GPP flare-ups.
Participants are put into 4 groups by chance. Three groups get different doses of spesolimab.
The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any
medicine.
Spesolimab and placebo are given as an injection under the skin. Participants are in the
study for about 1 year and 4 months. During this time, they visit the study site about 15
times. For the first 11 months, participants get spesolimab or placebo injections every
month. At the study visits, the doctors check participants' skin for signs of a new GPP
flare-up. The doctors also check the general health of the participants.
If a participant has a GPP flare-up during the study, more visits may be necessary. In case
of a flare-up, participants get a dose of spesolimab as an infusion into a vein.