A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Intervention: Spesolimab; Placebo
Intervention description: Solution for injection; Solution for injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a known and documented history of GPP per ERASPEN criteria (see Section
             3.3.1) 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.

          -  Patients with a GPPGA score of 0 or 1 at screening and randomization.

          -  Patients who are not on concomitant GPP treatment at time of randomization (V2) must
             have had at least two presentations of moderate to severe GPP flare in the past year,
             at least one of which had evidence of either fever and/or elevated CRP and/or elevated
             WBC, and/or asthenia and/or myalgia.

          -  Patients who are not on concomitant GPP treatment at time of randomization (V2) but
             who were on concomitant GPP treatment until shortly before randomization (V2) (≤ 12
             weeks before randomization), these patients must have a history of flaring while on
             concomitant treatment for GPP or in case of dose reduction or discontinuation of their
             concomitant medication.

          -  Patients who are on concomitant treatment regimen with retinoids and/or methotrexate
             and/or cyclosporine must stop at the day of randomization (V2). These patients must
             have a history of flaring while on concomitant treatment for GPP or in case of dose
             reduction or discontinuation of these concomitant medications.

          -  Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum
             weight of 40 kg is required.

          -  Signed and dated written informed consent and assent in accordance with ICH-GCP and
             local legislation prior to admission in the trial.

          -  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 CTP as well as in the patient,
             parent(s) (or patient's legal guardian) information.

        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:

               1. 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.

               2. Any prior exposure to BI 655130 or another IL36R inhibitor biologic.

          5. 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.

          6. 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.

          7. 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.

          8. History of allergy/hypersensitivity to the systemically administered trial medication
             agent or its excipients.

        Further exclusion criteria apply.