PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
- Registration Number
- NCT05670821
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with generalized pustular psoriasis (GPP) Spesolimab -
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nippon Boehringer Ingelheim Co., Ltd.
🇯🇵Tokyo, Japan