Active Generalized Pustular Psoriasis

To investigate safety, tolerability, pharmacokinetics, pharmacogenomics and efficacy of a single intravenous dose of BI 655130 in patients with active generalized pustular psoriasis.

BI 655130

BI 655130

Injection

150mg/7.5 mL

Primary endpoint:
The primary endpoint to assess safety and tolerability of BI 655130
administered intravenously, is the number [(N (%)] of patients with adverse
reactions, defined as drug-related AEs.

Secondary endpoints:
 Percent change from baseline in GPPASI total score at Week 2
 Proportion of patients with GPPGA total score of 0 (clear) or 1 (almost
clear) at Week 2
 Change from baseline in FACIT-Fatigue scale score at Week 2
 Change from baseline in Pain VAS score at Week 2
The following pharmacokinetic parameters will be determined as secondary
endpoints: Cmax, AUC0-∞

Main criteria for inclusion:
 Male or female patients, aged 18 to 75 years at screening (V2)
 A known and documented history of Generalized Pustular Psoriasis
regardless of the 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)
 Presenting with a flare of GPP with at least 10% BSA with
erythema and pustules
 A GPPGA score of at least moderate severity
 GPP patients receiving maintenance treatment with retinoids and/or
methotrexate for at least 4 weeks or GPP patients not receiving any
maintenance therapy at screening visit 2 (V2)
 Male and female patients must agree to use an effective birth
control method

Main exclusion criteria:
 Immediate life-threatening GPP flare or requiring intensive care
treatment, according to the investigator’s judgement. Lifethreatening complications mainly include, but are not limited to,
cardiovascular/cytokine driven shock, pulmonary distress.
 Identified, ongoing serious/severe infection
 Acute generalized exanthematous pustulosis (AGEP)
 Patient’s clinical presentation being considered due to the
differential diagnosis of toxic epidermal necrosis or StevensJohnson syndrome
 Use of restricted medication (see Table 4.2.2.1:1)
 Patients with dose escalation of their maintenance therapy with
methotrexate and/or retinoids within the 4 weeks preceding V2
(second screening visit)
 Background therapy with ciclosporin within the last 30 days
preceding the second screening visit (V2)
 Severe, progressive, or uncontrolled renal, hepatic, haematological,
endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric
disease, or signs and symptoms thereof, as judged by the
investigator. Patients with less than 3-fold ULN increase in AST
and/or ALT and/or alkaline phosphatase and/or with less than 2-fold
ULN increase in total bilirubin on infusion day (V3) may be
included, provided that no other cause of liver damage than GPP
has been identified