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Can a single infusion stop GPP flares in their tracks?

NCT ID NCT06013969

Disease control Sponsor: LEO Pharma 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 8 times

Summary

This study is testing whether the drug spesolimab can safely and effectively treat repeated flares of generalized pustular psoriasis (GPP), a serious skin condition. Adults with GPP who have had a flare will receive a single intravenous dose of spesolimab, with a possible second dose one week later. The main goal is to see if the treatment clears visible pustules within one week.

What this could mean

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

Active substance
spesolimab (Spevigo®)
What this could lead to
If successful, this could confirm that spesolimab is a safe and effective option for managing repeated GPP flares, offering patients a reliable treatment.
What could go wrong
This is a small, single-arm study with no placebo group, so results may be less conclusive. Side effects are possible, and the treatment may not work for everyone.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

42 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

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.

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: * Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status. * Patients must have a history of frequent GPP flares in the past * Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening * Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures * Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly Exclusion Criteria: * Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP) * Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques * Patients with primary erythrodermic psoriasis vulgaris * Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome * Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure * Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin * Presence of acute demyelinating neuropathy * Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator * Further exclusion criteria apply.

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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

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 330, Taiwan

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Faculdade de Medicina do ABC

    Santo André, 09060-870, Brazil

  • Farhat Hached Hospital

    Sousse, 4000, Tunisia

  • HOP Saint-Louis

    Paris, 75010, France

  • HOP Trousseau

    Chambray-lès-Tours, 37170, France

  • Hedi Chaker Hospital, Department of Dermatology

    Sfax, 1053, Tunisia

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang-Pulau Pinang-21953

    Georgetown Pulau Pinang, 10990, Malaysia

  • Hospital Putrajaya

    Putrajaya, 62250, Malaysia

  • Hospital Selayang

    Batu Caves, 68100, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, 80100, Malaysia

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Evangelico Mackenzie

    Curitiba, 80440-220, Brazil

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Klinikum der Universität München AÖR

    München, 80337, Germany

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Maharat Nakhonchiangmai Hospital

    Muang Chiang Mai, 50200, Thailand

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National University Hospital-Singapore-42005

    Singapore, 119228, Singapore

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)

    Mthatha, Eastern Cape, 5099, South Africa

  • Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

    Nagpur, 440019, India

  • Red River Research Partners, LLC

    Fargo, North Dakota, 58103, United States

  • SP medical college and associated group of hospitals

    Bikaner, 334003, India

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, 200000, China

  • Shanghai Tenth People's Hospital

    Shanghai, 200072, China

  • Southern Medical University Dermatology Hospital

    Guangzhou, 510091, China

  • Srinagarind Hospital

    Khon Kaen, 40000, Thailand

  • Sunway Medical Centre

    Selangor Darul Ehsan, 47500, Malaysia

  • University of California Irvine

    Irvine, California, 92697, United States

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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