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New drug rapidly clears pustules in rare psoriasis flare

NCT ID NCT03782792

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single dose of spesolimab in 53 people with generalized pustular psoriasis (GPP) experiencing a moderate-to-severe flare. The drug aims to quickly clear skin pustules. Results showed that more patients receiving spesolimab had no visible pustules after one week compared to placebo.

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 could provide a fast-acting treatment option for sudden, severe flares of generalized pustular psoriasis.
What could go wrong
This is a small Phase 2 trial with only 53 participants. Larger studies are needed to confirm safety and effectiveness. As with any new drug, unexpected side effects may emerge.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Started

Jan 2019

Finished

Jan 2021

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 to 75 years

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 GPPGA of 0 or 1 and a known and documented history of GPP per European Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) OR \-- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN) criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) * Male or female patients, aged 18 to 75 years at screening. * Signed and dated written informed consent prior to admission to the study in accordance with ICH GCP and local legislation prior to start of any screening procedures. * Women of childbearing potential 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. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause * Further inclusion criteria apply Exclusion Criteria: * Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome. * Patients with primary erythrodermic psoriasis vulgaris. * Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques. * Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP). * 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 renal failure. * Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin. * 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

  • 2nd Affiliated Hosp Zhejiang University College of Medical

    Hangzhou, 310009, China

  • Asahikawa Medical University Hospital

    Hokkaido, Asahikawa, 078-8510, Japan

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Farhat Hached Hospital

    Sousse, 4000, Tunisia

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • HOP Robert Debré

    Reims, 51092, France

  • HOP Saint-André

    Bordeaux, 33000, France

  • HOP Saint-Louis

    Paris, 75010, France

  • Hedi Chaker Hospital, Department of Dermatology

    Tunisia, 1053, Tunisia

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pakar Sultanah Fatimah

    Muar town, 84000, Malaysia

  • Hospital Pulau Pinang

    Pulau Pinang, 10990, Malaysia

  • Hospital Raja Permaisuri Bainun

    Negeri Perak/Ipoh, 30450, Malaysia

  • Hospital Selayang

    Kuala Selangor, 68100, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, 80100, Malaysia

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Klinikum der Universität München - Campus Innenstadt

    München, 80337, Germany

  • La Rabta Hospital

    Tunis, 1007, Tunisia

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602, Japan

  • National Taiwan University Hospital

    Taipei, 10016, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Ramathibodi Hospital

    Ratchatewi, Bangkok, 10400, Thailand

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, 200000, China

  • The First Hospital of Dalian Medical University

    Dalian, 116011, China

  • Tianjin Medical University General Hospital

    Tianjin, 30052, China

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • University Hospital of Lausanne

    Lausanne, 1011, Switzerland

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Miami

    Miami, Florida, 33125, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Universitätsklinikum Essen AöR

    Essen, 45147, Germany

More trials for these conditions

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