This study is open to people with generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027).
The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up.
Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein.
Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.
Eligibility
Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment — Up to 252 Weeks
Trial sites (58)
Facility
City
Region
Status
Oakland Hills Dermatology
Auburn Hills
Michigan
Icahn School of Medicine at Mount Sinai
New York
New York
Hospital Italiano de Buenos Aires
CABA
Argentina
Cliniques Universitaires Saint-Luc
Brussels
Belgium
Clínica Dermacross S.A.
Vitacura
Chile
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Guangzhou
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
China
Shanghai Skin Disease Hospital
Shanghai
China
Huashan Hospital, Fudan University
Shanghai
China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an
China
HOP Saint-André
Bordeaux
France
Hôpital de l'Archet
Nice
France
HOP Saint-Louis
Paris
France
HOP Robert Debré
Reims
France
Fachklinik Bad Bentheim
Bad Bentheim
Germany
Charité - Universitätsmedizin Berlin
Berlin
Germany
Universitätsklinikum Bonn AöR
Bonn
Germany
Universitätsklinikum Erlangen
Erlangen
Germany
Universitätsklinikum Frankfurt
Frankfurt am Main
Germany
Klinikum der Universität München - Campus Innenstadt
München
Germany
Westfälische Wilhelms-Universität Münster
Münster
Germany
Klinikum Oldenburg AöR
Oldenburg
Germany
Istituto Clinico Humanitas
Rozzano (MI)
Italy
Nagoya City University Hospital
Aichi, Nagoya
Japan
Tokyo Medical University Ibaraki Medical Center
Ibaraki, Inashiki-gun
Japan
Saitama Medical University Hospital
Saitama, Iruma-gun
Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji
Japan
Hospital Pulau Pinang-Pulau Pinang-21953
George Town
Malaysia
Hospital Raja Permaisuri Bainun
Ipoh
Malaysia
Hospital Sultanah Aminah
Johor Bahru
Malaysia
Hospital Sultan Ismail
Johor Bahru
Malaysia
Queen Elizabeth Hospital
Kota Kinabalu
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur
Malaysia
Hospital Selayang
Kuala Selangor
Malaysia
Sarawak General Hospital
Kuching, Sarawak
Malaysia
Hospital Pakar Sultanah Fatimah
Muar town
Malaysia
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey
Mexico
Southern Philippines Medical Center -Davao-62091
Davao City
Philippines
Iloilo Doctors Hospital
Iloilo City, Iloilo
Philippines
Zenith Skin Science Center Inc.
Makati City
Philippines
+ 18 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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