Loading clinical trials...

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity

NCT03782792•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

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.

Locations (37)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

The First Hospital of Dalian Medical University

Dalian, China

2nd Affiliated Hosp Zhejiang University College of Medical

Hangzhou, China

Shanghai Skin Disease Hospital

Shanghai, China

Huashan Hospital, Fudan University

Shanghai, China

Tianjin Medical University General Hospital

Tianjin, China

HOP Saint-André

Bordeaux, France

Key Dates

Start Date

January 31, 2019

Primary Completion Date

September 23, 2020

Completion Date

January 5, 2021

Last Updated

October 16, 2025

Enrollment

ACTUAL participants

Conditions

Generalized Pustular Psoriasis

Interventions

Spesolimab

DRUG

Placebo

DRUG

Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

NCT06477536

Generalized Pustular Psoriasis

View study

ACTIVE_NOT_RECRUITINGPHASE3

A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

NCT06323356

Generalized Pustular PsoriasisErythrodermic Psoriasis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

Generalized Pustular Psoriasis Registry in Costa Rica

Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis

A Clinical Trial of TQH2929 Injection in Patients With Acute Flare-up of Generalized Pustular Psoriasis

An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options