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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05670821
Collaborator
(none)
38
Enrollment
34
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
38 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-marketing Surveillance of Spesolimab I.V. Infusion in Improvement of Generalized Pustular Psoriasis (GPP) With Acute Symptoms in Japan
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Patients with generalized pustular psoriasis (GPP)

Drug: Spesolimab
Spesolimab

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05670821
Other Study ID Numbers:
  • 1368-0093
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Jan 4, 2023