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CompletedNCT05670821Updated Oct 20, 2025

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

An observational study in Generalized Pustular Psoriasis, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-20.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Generalized Pustular Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 52 is below the median of 200 across 396 observational studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with generalized pustular psoriasis (GPP).

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with generalized pustular psoriasis (GPP)

    Drug: Spesolimab

Interventions

  • DrugSpesolimab

    Spesolimab

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What researchers measure

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.

    Time frame: Up to 36 weeks

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Study locations

1 site
  • Nippon Boehringer Ingelheim Co., Ltd.
    Tokyo, 1416017, Japan
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References and documents

Related links

Individual participant data

Plan to share: No — 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05670821
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Apr 18, 2023
Primary completion
Oct 6, 2025
Completion
Oct 6, 2025
Last update
Oct 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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