Overview

The present trial will be performed to characterize the dose-response curve for BI 655130 in patients with a history of Generalized Pustular Psoriasis (GPP, per European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria) who are now (at screening and at randomization) presenting with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 (clear, or almost clear).

Eligibility

Inclusion Criteria:

1. Patients with a known and documented history of GPP per ERASPEN criteria regardless of IL36RN mutation status, with at least 2 presentations of moderate to severe GPP flares with fresh pustulation (new appearance or worsening) in the past.
2. Patients with a GPPGA score of 0 or 1 at screening and randomization.
3. Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum weight of 40 kg is required.
4. Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial.
5. Women of childbearing potential (WOCBP)1 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. A list of contraception methods meeting these criteria is provided in the Clinical Trial Protocol (CTP) as well as in the patient, parent(s) (or patient's legal guardian) information.

Further inclusion criteria apply.

Exclusion Criteria:

1. Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.
2. Patients with primary erythrodermic psoriasis vulgaris.
3. Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
4. Treatment with:
5. Any restricted medication as specified in the CTP, or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator.
6. Any prior exposure to BI 655130 or another IL36R inhibitor biologic.
7. Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation), as assessed by the investigator.
8. Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomization. A patient can be re-screened if the patient was treated and is cured from the acute infection.
9. Active or Latent Tuberculosis (TB):
   • Patients with active tuberculosis should be excluded
   • Patients with a positive QuantiFERON (or if applicable, T-Spot) TB test during screening are excluded, unless the patient had previous diagnosis of active or latent TB and has completed appropriate treatment per the discretion of the local investigator within the last 3 years and at the latest at the time of screening (i.e. 2 to 4 weeks before study drug administration); patients may be re-screened once to meet this criterion)
   • Patients with suspected false positive or indeterminate QuantiFERON (or if applicable, T-Spot) TB result may be re-tested once
   • If QuantiFERON (or if applicable, T-Spot) TB testing is not available or provides indeterminate results after repeat testing, a tuberculin skin test (TST) can be performed: A TST reaction of 10mm (5mm if receiving 15mg/d prednisone or its equivalent) is considered positive.
10. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.

Further exclusion criteria apply.