CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
spesolimabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05200247
NCT05200247Phase 3Completed

Multi-centre, Open-label, Expanded Access Trial of Spesolimab i.v. in Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Flare

Boehringer Ingelheim·interventional·Posted Jan 20, 2022·Updated Feb 25, 2025

In Brief

A Phase 3 clinical trial evaluating spesolimab for Generalized Pustular Psoriasis. Completed, enrolled 11 participants across 9 sites.

Detailed Summary

This Expanded Access trial in Japan is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options. Participants get a single infusion of spesolimab into a vein. They can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful. Participants are in the program for about 4 months and visit the study site about 5 to 6 times. The doctors regularly check participants' health and take note of any unwanted effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 20, 2022
Enrollment StartFeb 17, 2022
Primary CompletionMar 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.5 years ago

Interventions

spesolimabdrug

solution for infusion