Psoriasis Clinical Trial
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
To evaluate the long-term safety and efficacy of spesolimab in patients with GPP, who have completed previous spesolimab trials and are qualified for entry in this trial.
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 220.127.116.11 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
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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There are 55 Locations for this study
Auburn Hills Michigan, 48326, United States
New York New York, 10029, United States
Caba , C1199, Argentina
Bruxelles , 1200, Belgium
Vitacura , 76408, Chile
Guangzhou , 51028, China
Hangzhou , 31000, China
Shanghai , 20000, China
Shanghai , 20004, China
Xi'An , 71000, China
Bordeaux , 33000, France
Nice , 06200, France
Paris , 75010, France
Reims , 51092, France
Bad Bentheim , 48455, Germany
Berlin , 10117, Germany
Bonn , 53127, Germany
Frankfurt am Main , 60596, Germany
München , 80337, Germany
Münster , 48149, Germany
Oldenburg , 26133, Germany
Rozzano (MI) , 20089, Italy
Aichi, Nagoya , 467-8, Japan
Ibaraki, Inashiki-gun , 300-0, Japan
Saitama, Iruma-gun , 350-0, Japan
Tokyo, Hachioji , 193-0, Japan
Seoul , 03722, Korea, Republic of
George Town , 10990, Malaysia
Ipoh , 30450, Malaysia
Johor Bahru , 80100, Malaysia
Johor Bahru , 81100, Malaysia
Kota Kinabalu , 88586, Malaysia
Kuala Lumpur , 50586, Malaysia
Kuching, Sarawak , 93586, Malaysia
Muar , 84000, Malaysia
Selangor , 68100, Malaysia
Monterrey , 64460, Mexico
Davao City , 8000, Philippines
Iloilo City, Iloilo , 5000, Philippines
Makati City , 1229, Philippines
Chelyabinsk , 45404, Russian Federation
Kazan , 42011, Russian Federation
Kirov , 61003, Russian Federation
Saratov , 41002, Russian Federation
St. Petersburg , 19012, Russian Federation
Esplugues Del Llobregat , 08950, Spain
Linkou , 333, Taiwan
Taipei , 10002, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Sousse , 4000, Tunisia
Tunisia , 1053, Tunisia
Tunis , 1007, Tunisia
Istanbul , 34890, Turkey
Ha Noi , 10000, Vietnam
Ho Chi Minh , 70000, Vietnam
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