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

NCT03782792 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-10-16

Study results available
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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.

Conditions

  • Generalized Pustular Psoriasis

Interventions

DRUG

Spesolimab

Solution for infusion

DRUG

Placebo

Solution for infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2020-09-23
Completion
2021-01-05
FDA Drug
Yes

Countries

  • United States
  • China
  • France
  • Germany
  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782792 on ClinicalTrials.gov