Eine Studie zur Untersuchung von BI 655130 bei Patienten mit einem Schub einer Hautkrankheit, der sogenannten generalisierten pustulösen Psoriasis

Drug: Spesolimab;Drug: Placebo

Inclusion Criteria:

- Patients with GPPGA of 0 or 1 and a known and documented history of GPP per European
Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN
mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia,
and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood
neutrophilia (above ULN) OR

-- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN)
criteria of GPP with a known and documented history of GPP (per ERASPEN criteria)
regardless of IL36RN mutation status, with previous evidence of fever, and/or
asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with
peripheral blood neutrophilia (above ULN)

- Male or female patients, aged 18 to 75 years at screening.

- Signed and dated written informed consent prior to admission to the study in
accordance with ICH GCP and local legislation prior to start of any screening
procedures.

- Women of childbearing potential must be ready and able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
year when used consistently and correctly. Note: A woman is considered of childbearing
potential, i.e. fertile, following menarche and until becoming postmenopausal unless
permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral
salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent
sterilization. A postmenopausal state is defined as no menses for 12 months without an
alternative medical cause

- Further inclusion criteria apply

Exclusion Criteria:

- Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.

- Patients with primary erythrodermic psoriasis vulgaris.

- Patients with primary plaque psoriasis vulgaris without presence of pustules or with
pustules that are restricted to psoriatic plaques.

- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).

- Immediate life-threatening flare of GPP or requiring intensive care treatment,
according to the investigator's judgement. Life-threatening complications mainly
include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary
distress syndrome, or renal failure.

- Severe, progressive, or uncontrolled hepatic disease, defined as >3- fold Upper Limit
of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN
elevation in total bilirubin.

- Further exclusion criteria apply