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New shot could stop GPP flares before they start

NCT ID NCT04399837

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a monthly injection of spesolimab can prevent flare-ups of generalized pustular psoriasis (GPP), a rare and severe skin condition. 123 people aged 12 to 75 with clear or nearly clear skin joined the trial. They received either one of three doses of spesolimab or a placebo for 11 months, and doctors tracked how long it took for a new flare to appear.

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

123 people

The number who actually took part.

Started

Jun 2020

Finished

Nov 2022

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

12 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 a known and documented history of GPP per ERASPEN criteria (see Section 3.3.1) regardless of IL36RN mutation status, with at least 2 presentations of moderate to severe GPP flares with fresh pustulation (new appearance or worsening) in the past. * Patients with a GPPGA score of 0 or 1 at screening and randomization. * Patients who are not on concomitant GPP treatment at time of randomization (V2) must have had at least two presentations of moderate to severe GPP flare in the past year, at least one of which had evidence of either fever and/or elevated CRP and/or elevated WBC, and/or asthenia and/or myalgia. * Patients who are not on concomitant GPP treatment at time of randomization (V2) but who were on concomitant GPP treatment until shortly before randomization (V2) (≤ 12 weeks before randomization), these patients must have a history of flaring while on concomitant treatment for GPP or in case of dose reduction or discontinuation of their concomitant medication. * Patients who are on concomitant treatment regimen with retinoids and/or methotrexate and/or cyclosporine must stop at the day of randomization (V2). These patients must have a history of flaring while on concomitant treatment for GPP or in case of dose reduction or discontinuation of these concomitant medications. * Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum weight of 40 kg is required. * Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial. * Women of childbearing potential (WOCBP)1 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. A list of contraception methods meeting these criteria is provided in the CTP as well as in the patient, parent(s) (or patient's legal guardian) information. Exclusion Criteria: 1. Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome. 2. Patients with primary erythrodermic psoriasis vulgaris. 3. Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold Upper Limit of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin. 4. Treatment with: 1. Any restricted medication as specified in the CTP, or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator. 2. Any prior exposure to BI 655130 or another IL36R inhibitor biologic. 5. Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation), as assessed by the investigator. 6. Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomization. A patient can be re-screened if the patient was treated and is cured from the acute infection. 7. Active or Latent Tuberculosis (TB): * Patients with active tuberculosis should be excluded * Patients with a positive QuantiFERON® (or if applicable, T-Spot®) TB test during screening are excluded, unless the patient had previous diagnosis of active or latent TB and has completed appropriate treatment per the discretion of the local investigator within the last 3 years and at the latest at the time of screening (i.e. 2 to 4 weeks before study drug administration); patients may be re-screened once to meet this criterion) * Patients with suspected false positive or indeterminate QuantiFERON® (or if applicable, T-Spot®) TB result may be re-tested once * If QuantiFERON® (or if applicable, T-Spot®) TB testing is not available or provides indeterminate results after repeat testing, a tuberculin skin test (TST) can be performed: A TST reaction of ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent) is considered positive. 8. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients. 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

  • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

    Saint Petersburg, 197022, Russia

  • Arthritis Clinical Research Trials

    Cape Town, 7405, South Africa

  • Bezmi Alem Valide Sultan Vakif Gureba Egitim ve Arastirma Hastanesi

    Istanbul, 34093, Turkey (Türkiye)

  • Brussels - UNIV Saint-Luc

    Brussels, 1200, Belgium

  • Buenos Aires Skin S.A.

    CABA, C1055AA0, Argentina

  • Center for Skin Research, Testing and Product Development

    Makati City, 1229, Philippines

  • Centro de Investigación de Enfermedades Autoinmunes S.C.

    Guadalajara, 44610, Mexico

  • Chang Gung Medical Foundation (CGMF) - Linkou Bran

    Linkou District, 333, Taiwan

  • Charles Nicolle Hospital

    Tunis, 1008, Tunisia

  • Clínica Dermacross S.A.

    Vitacura, 7640881, Chile

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • FSBEI HE "Kirov State Medical University"

    Kirov, 610035, Russia

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • Farhat Hached Hospital

    Sousse, 4000, Tunisia

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54643, Greece

  • HCMC Hospital of Dermato-Venereology

    Ho Chi Minh City, 70000, Vietnam

  • HOP Saint-Louis

    Paris, 75010, France

  • HOP l'Archet

    Nice, 06200, France

  • Habib Thameur Hospital

    Tunis, 1008, Tunisia

  • Hedi Chaker Hospital, Department of Dermatology

    Sfax, 1053, Tunisia

  • Hospital Italiano de Buenos Aires

    CABA, C1056AB, Argentina

  • 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

    Ipoh, 30450, Malaysia

  • Hospital Sant Joan de Déu

    Esplugues Del Llobregat, 08950, Spain

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, 80100, Malaysia

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Iloilo Doctors Hospital

    Iloilo City, Iloilo, 5000, Philippines

  • Institute of Dermatology

    Bangkok, 10400, Thailand

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Klinikum Oldenburg AöR

    Oldenburg, 26133, Germany

  • Klinikum der Universität München - Campus Innenstadt

    München, 80337, Germany

  • Kyushu Rosai Hospital

    Fukuoka, Kitakyushu, 800-0296, Japan

  • LLC "Avrora Medfort"

    Saint Petersburg, 194156, Russia

  • LLC "Medical Center Azbuka Zdorovia"

    Kazan', 420111, Russia

  • LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

    Saint Petersburg, 190123, Russia

  • La Rabta Hospital

    Tunis, 1007, Tunisia

  • Marmara Universitesi Tip Fakultesi

    Istanbul, 34460, Turkey (Türkiye)

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602, Japan

  • National Hospital of Dermatology and Venereology

    Hà Nội, 10000, Vietnam

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326, United States

  • Pusan National Univ. Hosp

    Busan, 49241, South Korea

  • Queen Elizabeth Hospital

    Kota Kinabalu, 88586, Malaysia

  • Ramathibodi Hospital

    Ratchatewi, Bangkok, 10400, Thailand

  • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

    Chelyabinsk, 454048, Russia

  • Saitama Medical University Hospital

    Saitama, Iruma-gun, 350-0495, Japan

  • Saratov State Med.Univ.n.a.Razumovskogo

    Saratov, 410028, Russia

  • Sarawak General Hospital

    Kuching, Sarawak, 93586, Malaysia

  • Second Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710004, China

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shanghai Skin Disease Hospital

    Shanghai, 200000, China

  • Southern Philippines Medical Center

    Davao City, 8000, Philippines

  • Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

    Guangzhou, 510288, China

  • The First Hospital of China Medical University

    Shenyang, 110001, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, 300120, China

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998, Japan

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023, Japan

  • Tokyo Medical University Ibaraki Medical Center

    Ibaraki, Inashiki-gun, 300-0395, Japan

  • Uludag University Medicine Faculty Departmant of Dermatology

    Bursa, 16059, Turkey (Türkiye)

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Würzburg AÖR

    Würzburg, 97080, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

More trials for these conditions

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