NCT06013969

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Generalized Pustular Psoriasis

Interventions

Type	Name	Description
DRUG	Spesolimab	Spesolimab intravenous (i.v.) infusion

Timeline

• Start date: 2023-10-22
• Primary completion: 2026-07-23
• Completion: 2026-08-14
• First posted: 2023-08-28
• Last updated: 2026-04-15

Locations

35 sites across 17 countries: United States, Australia, Belgium, Brazil, China, France, Germany, India, Italy, Malaysia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia

Regulatory

• FDA-regulated drug study