PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.

Completed

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Key information

Conditions

Generalized Pustular Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan
Patients who have never been treated with Spesolimab I.V. Infusion before enrolment

Exclusion criteria

None

Treatment and study plan

spesolimab

Drug

Spesolimab

Primary outcomes

Incidence of adverse drug reactions (ADRs)

Time frame: Up to 36 weeks

Incidence of adverse drug reactions (ADRs). An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jan 4, 2023
Registry last updated: Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed