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A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis

NCT04399837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-10-17

Study results available
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Summary

This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups.

Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine.

Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants.

If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.

Conditions

  • Generalized Pustular Psoriasis

Interventions

DRUG

Spesolimab

Solution for injection

DRUG

Placebo

Solution for injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2022-11-23
Completion
2022-11-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Chile
  • China
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Philippines
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • Vietnam

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 NCT04399837 on ClinicalTrials.gov