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

Generalized Pustular Psoriasis Clinical Trial

Official title:

Effisayil™ ON: An Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Spesolimab Treatment in Patients With Generalized Pustular Psoriasis (GPP)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03886246
• Other study ID #: 1368-0025
• Secondary ID: 2018-003080-56
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 27, 2019
• Est. completion date: January 20, 2028

Study information

• Verified date: January 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: January 20, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• Spesolimab
Solution for infusion
• Spesolimab
Solution for injection

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Caba
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Chile	Clínica Dermacross S.A.	Vitacura
China	Sun yet-sen Memorial Hospital, Sun yet-sen Univesity	Guangzhou
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou
China	Huashan Hospital, Fudan University	Shanghai
China	Shanghai Skin Disease Hospital	Shanghai
China	Second Affiliated Hospital of Xi'an JiaoTong University	Xi'an
France	HOP Saint-André	Bordeaux
France	HOP l'Archet	Nice
France	HOP Saint-Louis	Paris
France	HOP Robert Debré	Reims
Germany	Fachklinik Bad Bentheim	Bad Bentheim
Germany	Charité - Universitätsmedizin Berlin	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
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Japan	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
Korea, Republic of	Severance Hospital	Seoul
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Sarawak General Hospital	Kuching, Sarawak
Malaysia	Hospital Pakar Sultanah Fatimah	Muar
Malaysia	Hospital Selayang	Selangor
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Philippines	Southern Philippines Medical Center	Davao City
Philippines	Iloilo Doctors Hospital	Iloilo City, Iloilo
Philippines	Center for Skin Research, Testing and Product Development	Makati City
Russian Federation	SBHI Chelyabinsk Reg.Clin.Derma.Dispen.	Chelyabinsk
Russian Federation	LLC "Medical Center Azbuka Zdorovia"	Kazan
Russian Federation	FSBEI HE "Kirov State Medical University"	Kirov
Russian Federation	Saratov State Med.Univ.n.a.Razumovskogo	Saratov
Russian Federation	LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg	St. Petersburg
Spain	Hospital Sant Joan de Déu	Esplugues Del Llobregat
Taiwan	Chang Gung Medical Foundation (CGMF) - Linkou Bran	Linkou
Taiwan	National Taiwan University Hospital	Taipei
Thailand	Institute of Dermatology	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Tunisia	Farhat Hached Hospital	Sousse
Tunisia	La Rabta Hospital	Tunis
Tunisia	Hedi Chaker Hospital, Department of Dermatology	Tunisia
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi	Istanbul
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Icahn School of Medicine at Mount Sinai	New York	New York
Vietnam	National Hospital of Dermatology and Venereology	Ha Noi
Vietnam	HCMC Hospital of Dermato-Venereology	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Belgium,  Chile,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Russian Federation,  Spain,  Taiwan,  Thailand,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment		Up to 252 Weeks
Secondary	The reoccurrence of a GPP flare defined by GPPGA	The total GPPGA score ranges from 0 to 4 with a higher score indicating a higher grade of inflammation.	Up to 252 Weeks
Secondary	Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)		Up to 252 Weeks
Secondary	A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit		Up to 252 Weeks
Secondary	Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit	The PSS score ranges from None to Very Severe with a higher score indicating a higher severity of psoriasis symptom.	Up to 252 Weeks

External Links

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