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Effisayil 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP

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Effisayil 2: Multi-center, randomized, parallel group, double blind, placebo controlled, Phase IIb dose-finding study to evaluate efficacy and safety of BI 655130 (Spesolimab) compared to placebo in preventing generalized pustular psoriasis (GPP) flares in patients with history of GPP

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs Spesolimab (Primary) ; Spesolimab (Primary)
  • Indications Generalised pustular psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms Effisayil 2; EFFISAYIL TM 2
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim GmbH International; Boehringer Ingelheim Pharma KG

    • Most Recent Events

    • 07 Mar 2025 Results of post-hoc analyses published in the Boehringer Ingelheim Media Release.
    • 05 Feb 2025 According to a Boehringer Ingelheim media release, Boehringer Ingelheim Canada announces that intravenous and subcutaneous supplies of SPEVIGO are now available in Canada for the treatment of generalized pustular psoriasis (GPP) in patients 12 years of age and older, weighing at least 40 kg. The subcutaneous formulation for chronic GPP treatment was granted market authorization in July 2024 by Health Canada. The regulatory authorities' decision is based on results from the EFFISAYIL-2 study.
    • 29 Jul 2024 According to a Boehringer Ingelheim media release, based on results form this trial, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of a new indication of SPEVIGO (spesolimab) injection for the prevention of generalized pustular psoriasis (GPP) flares in adults and adolescents from 12 years of age.

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