Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
NCT ID: NCT03886246
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
131 participants
INTERVENTIONAL
2019-05-29
2028-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
NCT04493424
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
NCT06886009
Topical CP-690,550 For Chronic Plaque Psoriasis
NCT00678561
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
NCT01186744
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
NCT03850483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spesolimab (every 6 weeks)
Spesolimab
Solution for infusion
Spesolimab
Solution for injection
Spesolimab (every 12 weeks)
Spesolimab
Solution for injection
Spesolimab (every 4 weeks)
Spesolimab
Solution for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spesolimab
Solution for infusion
Spesolimab
Solution for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
12 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
HOP l'Archet
Nice, , France
HOP Saint-Louis
Paris, , France
HOP Robert Debré
Reims, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite Universitätsmedizin Berlin KöR
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , 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-40735
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
Center for Skin Research, Testing and Product Development
Makati City, , Philippines
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
Chelyabinsk, , Russia
LLC "Medical Center Azbuka Zdorovia"
Kazan', , Russia
FSBEI HE "Kirov State Medical University"
Kirov, , Russia
LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg
Saint Petersburg, , Russia
Saratov State Med.Univ.n.a.Razumovskogo
Saratov, , Russia
Singapore General Hospital
Singapore, , Singapore
Severance Hospital
Seoul, , South Korea
Hospital Sant Joan de Déu
Esplugues Del Llobregat, , Spain
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Institute of Dermatology
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Farhat Hached Hospital
Sousse, , Tunisia
La Rabta Hospital
Tunis, , Tunisia
Hedi Chaker Hospital, Department of Dermatology
Tunisia, , Tunisia
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
National Hospital of Dermatology and Venereology
Hà Nội, , Vietnam
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003080-56
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1368-0025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.