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New drug spesolimab under Real-World watch for rare skin disease

NCT ID NCT05670821

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study monitored 52 Japanese patients with generalized pustular psoriasis (GPP) who received spesolimab for acute symptoms. Researchers tracked side effects and disease activity in everyday clinical settings, not a controlled lab environment. The goal was to see how well the drug works and how safe it is when used in real-world practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spesolimab
What this could lead to
If successful, this study could confirm that spesolimab is safe and effective for controlling acute flares of generalized pustular psoriasis in everyday medical practice.
What could go wrong
This is a small, non-interventional observational study with no control group, so results may not prove cause and effect. Side effects are possible, and findings may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

52 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with generalized pustular psoriasis (GPP).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

generalized pustular psoriasis psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized pustular psoriasis

Contacts and locations

Locations

  • Nippon Boehringer Ingelheim Co., Ltd.

    Tokyo, 1416017, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.