Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Intervention: Spesolimab; Placebo
Intervention description: Solution for infusion; Solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo
      in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of
      moderate to severe intensity.
    

Eligibility criteria:

        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