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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

131

Study ID:

NCT03886246

Recruitment Status:

Active, not recruiting

Sponsor:

Boehringer Ingelheim

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There are 55 Locations for this study

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Oakland Hills Dermatology
Auburn Hills Michigan, 48326, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Hospital Italiano de Buenos Aires
Caba , C1199, Argentina
Brussels - UNIV Saint-Luc
Bruxelles , 1200, Belgium
Clínica Dermacross S.A.
Vitacura , 76408, Chile
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Guangzhou , 51028, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou , 31000, China
Shanghai Skin Disease Hospital
Shanghai , 20000, China
Huashan Hospital, Fudan University
Shanghai , 20004, China
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an , 71000, China
HOP Saint-André
Bordeaux , 33000, France
HOP l'Archet
Nice , 06200, France
HOP Saint-Louis
Paris , 75010, France
HOP Robert Debré
Reims , 51092, France
Fachklinik Bad Bentheim
Bad Bentheim , 48455, Germany
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitätsklinikum Bonn AöR
Bonn , 53127, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main , 60596, Germany
Klinikum der Universität München - Campus Innenstadt
München , 80337, Germany
Westfälische Wilhelms-Universität Münster
Münster , 48149, Germany
Klinikum Oldenburg AöR
Oldenburg , 26133, Germany
Istituto Clinico Humanitas
Rozzano (MI) , 20089, Italy
Nagoya City University Hospital
Aichi, Nagoya , 467-8, Japan
Tokyo Medical University Ibaraki Medical Center
Ibaraki, Inashiki-gun , 300-0, Japan
Saitama Medical University Hospital
Saitama, Iruma-gun , 350-0, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji , 193-0, Japan
Severance Hospital
Seoul , 03722, Korea, Republic of
Hospital Pulau Pinang
George Town , 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh , 30450, Malaysia
Hospital Sultanah Aminah
Johor Bahru , 80100, Malaysia
Hospital Sultan Ismail
Johor Bahru , 81100, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu , 88586, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur , 50586, Malaysia
Sarawak General Hospital
Kuching, Sarawak , 93586, Malaysia
Hospital Pakar Sultanah Fatimah
Muar , 84000, Malaysia
Hospital Selayang
Selangor , 68100, Malaysia
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Southern Philippines Medical Center
Davao City , 8000, Philippines
Iloilo Doctors Hospital
Iloilo City, Iloilo , 5000, Philippines
Center for Skin Research, Testing and Product Development
Makati City , 1229, Philippines
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
Chelyabinsk , 45404, Russian Federation
LLC "Medical Center Azbuka Zdorovia"
Kazan , 42011, Russian Federation
FSBEI HE "Kirov State Medical University"
Kirov , 61003, Russian Federation
Saratov State Med.Univ.n.a.Razumovskogo
Saratov , 41002, Russian Federation
LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg
St. Petersburg , 19012, Russian Federation
Hospital Sant Joan de Déu
Esplugues Del Llobregat , 08950, Spain
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou , 333, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Institute of Dermatology
Bangkok , 10400, Thailand
Ramathibodi Hospital
Bangkok , 10400, Thailand
Farhat Hached Hospital
Sousse , 4000, Tunisia
Hedi Chaker Hospital, Department of Dermatology
Tunisia , 1053, Tunisia
La Rabta Hospital
Tunis , 1007, Tunisia
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul , 34890, Turkey
National Hospital of Dermatology and Venereology
Ha Noi , 10000, Vietnam
HCMC Hospital of Dermato-Venereology
Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

131

Study ID:

NCT03886246

Recruitment Status:

Active, not recruiting

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

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