PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan
1 other identifier
observational
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedStudy Start
First participant enrolled
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2025
CompletedOctober 20, 2025
October 1, 2025
2.5 years
January 2, 2023
October 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reactions (ADRs)
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.
Up to 36 weeks
Study Arms (1)
Patients with generalized pustular psoriasis (GPP)
Interventions
Eligibility Criteria
Patients with generalized pustular psoriasis (GPP).
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, 1416017, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
April 18, 2023
Primary Completion
October 6, 2025
Study Completion
October 6, 2025
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency