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Clinical Trials in the USA / NCT03886246
Active, not recruiting Phase 2

Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study

NCT03886246 · tracked via the Priya Life Science USA tracker
Sponsor
LEO Pharma
Phase
Phase 2
Started
2019-05-29
Last updated
2026-09-01

Condition(s) studied

Generalized Pustular Psoriasis

Investigational drug(s) / intervention(s)

SpesolimabSpesolimab

Spesolimab: Solution for infusion

Spesolimab: Solution for injection

Study summary

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)

Trial sites (58)

FacilityCityRegionStatus
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.

More LEO Pharma trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT03886246 on ClinicalTrials.gov ↗ ← All trials in the USA