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New drug shows promise for rare skin disease over nearly 5 years

NCT ID NCT03886246

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 02, 2026 · Updated 6 times

Summary

This study looks at the long-term safety and effectiveness of spesolimab in people with generalized pustular psoriasis (GPP), a rare and severe skin condition. All 131 participants had already taken spesolimab in a previous study and will continue treatment for up to 5 years. Researchers will monitor side effects and how quickly symptoms improve during flare-ups.

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 confirm spesolimab as a safe long-term treatment to control GPP flares and improve symptoms.
What could go wrong
This is a Phase 2 open-label study with no placebo group, so results may not prove effectiveness definitively. Long-term safety data is still being collected.

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

131 people

The number who actually took part.

Started

May 2019

Expected to finish

Apr 2028

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

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: * Male or female patients who have completed the treatment period without premature discontinuation in the previous spesolimab trial and are willing and able to continue treatment in the current trial * 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. A list of contraception methods meeting these criteria is provided in Section 4.2.2.3 as well as in the patient information. 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. * Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial Exclusion Criteria: * Evidence of flare symptoms of moderate/severe intensity at screening. * Treatment with any restricted medication as specified in the protocol, or any drugs considered by the investigator likely to interfere with the safe conduct of the study since the last visit of the previous spesolimab trial and during the screening period for the current trial, with the exception of methotrexate, cyclosporine, or retinoids started following rescue treatment for GPP flare in trial 1368-0027. * Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in Aspartate Transaminase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2- fold ULN elevation in total bilirubin. * Patients with congestive heart disease, as assessed by the investigator. * Relevant chronic or acute infections including human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from acute infection. * Active or Latent tuberculosis (TB): * Patients with active tuberculosis should be excluded * Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON®-TB-Gold Plus or T-spot®. Patients with positive IGRA (indicating active or latent tuberculosis) are excluded unless they have completed treatment for active or latent tuberculosis per investigator discretion, at the time of screening. * Patients with indeterminate QuantiFERON®-TB-Gold Plus or invalid/borderline T-spot® may be retested with IGRA (once) or Tuberculin Skin test (TST). * TST or any alternative test/procedure (as per local standards) to rule out TB can be performed if IGRA is not available or indeterminate. A TST reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or other immunosuppressant) is considered positive. Patients with a positive TST are excluded unless they have completed treatment as above. * History of allergy/hypersensitivity to a systemically administered trial medication agent or its excipients. * Any documented active or suspected malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix. 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

  • Chang Gung Medical Foundation (CGMF) - Linkou Bran

    Linkou District, 333, Taiwan

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica Dermacross S.A.

    Vitacura, 7640881, Chile

  • FSBEI HE "Kirov State Medical University"

    Kirov, 610035, Russia

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • Farhat Hached Hospital

    Sousse, 4000, Tunisia

  • HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092

    Ho Chi Minh City, 70000, Vietnam

  • HOP Robert Debré

    Reims, 51092, France

  • HOP Saint-André

    Bordeaux, 33000, France

  • HOP Saint-Louis

    Paris, 75010, France

  • Hedi Chaker Hospital, Department of Dermatology

    Sfax, 1053, Tunisia

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABD, Argentina

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586, Malaysia

  • Hospital Pakar Sultanah Fatimah

    Muar town, 84000, Malaysia

  • Hospital Pulau Pinang-Pulau Pinang-21953

    George Town, 10990, Malaysia

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450, Malaysia

  • Hospital Sant Joan de Déu

    Esplugues Del Llobregat, 08950, Spain

  • Hospital Selayang

    Kuala Selangor, 68100, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, 80100, Malaysia

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Huashan Hospital, Fudan University

    Shanghai, 200040, China

  • Hôpital de l'Archet

    Nice, 06200, France

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Iloilo Doctors Hospital

    Iloilo City, Iloilo, 5000, Philippines

  • Institute of Dermatology

    Bangkok, 10400, Thailand

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • Klinikum Oldenburg AöR

    Oldenburg, 26133, Germany

  • Klinikum der Universität München - Campus Innenstadt

    München, 80337, Germany

  • 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 Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890, 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

  • Queen Elizabeth Hospital

    Kota Kinabalu, 88586, Malaysia

  • Ramathibodi Hospital

    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

  • Singapore General Hospital

    Singapore, 169608, Singapore

  • Southern Philippines Medical Center -Davao-62091

    Davao City, 8000, Philippines

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

    Guangzhou, 510288, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, Hachioji, 193-0998, Japan

  • Tokyo Medical University Ibaraki Medical Center

    Ibaraki, Inashiki-gun, 300-0395, Japan

  • Universitätsklinikum Bonn AöR

    Bonn, 53127, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596, Germany

  • Westfälische Wilhelms-Universität Münster

    Münster, 48149, Germany

  • Zenith Skin Science Center Inc.

    Makati City, 1229, Philippines

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