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NCT05670821 Clinical Trial

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

Generalized Pustular Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05670821
Other study ID # 1368-0093
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2023
Est. completion date December 31, 2025

Study information
Verified date October 2023
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Spesolimab
Spesolimab

Locations
Country Name City State
Japan Nippon Boehringer Ingelheim Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06100991 - CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
Recruiting NCT06013969 - A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares Phase 4
Completed NCT05512598 - HB0034 in Patients With Generalized Pustular Psoriasis (GPP) Phase 1
Active, not recruiting NCT03886246 - Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study Phase 2
Recruiting NCT06323356 - A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Completed NCT05239039 - An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Completed NCT04399837 - A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis Phase 2
Completed NCT03942042 - A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis Phase 4
Completed NCT06391996 - Biologic Therapy for Generalized Pustular Psoriasis
Completed NCT03782792 - Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis Phase 2
Completed NCT03619902 - A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis Phase 2
Active, not recruiting NCT04566471 - Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
Recruiting NCT06295692 - A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Completed NCT05200247 - An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Active, not recruiting NCT05366855 - Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis Phase 3
Completed NCT05352893 - Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP Phase 3

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