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 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 1368-00252018-003080-562023-509216-28-00
• Study Type: interventional
• Target: 131
• Locations: 20 countries
• Sites: 56

Brief 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.

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment

  Up to 252 Weeks

Secondary Outcomes (4)

• The reoccurrence of a GPP flare defined by GPPGA

  Up to 252 Weeks

• Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)

  Up to 252 Weeks

• A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit

  Up to 252 Weeks

• Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit

  Up to 252 Weeks

Study Arms (3)

Spesolimab (every 6 weeks)

EXPERIMENTAL

Drug: Spesolimab

Spesolimab (every 12 weeks)

EXPERIMENTAL

Drug: Spesolimab

Spesolimab (every 4 weeks)

EXPERIMENTAL

Drug: Spesolimab

Interventions

Spesolimab DRUG

Solution for infusion

Spesolimab (every 6 weeks)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (57)

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Hospital Italiano de Buenos Aires

CABA, C1199ABD, Argentina

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Clínica Dermacross S.A.

Vitacura, 7640881, Chile

Location

Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

Guangzhou, 510288, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Shanghai Skin Disease Hospital

Shanghai, 200000, China

Location

Huashan Hospital, Fudan University

Shanghai, 200040, China

Location

Second Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710004, China

Location

HOP Saint-André

Bordeaux, 33000, France

Location

Hôpital de l'Archet

Nice, 06200, France

Location

HOP Saint-Louis

Paris, 75010, France

Location

HOP Robert Debré

Reims, 51092, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Klinikum der Universität München - Campus Innenstadt

München, 80337, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, 48149, Germany

Location

Klinikum Oldenburg AöR

Oldenburg, 26133, Germany

Location

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

Nagoya City University Hospital

Aichi, Nagoya, 467-8602, Japan

Location

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Inashiki-gun, 300-0395, Japan

Location

Saitama Medical University Hospital

Saitama, Iruma-gun, 350-0495, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, Hachioji, 193-0998, Japan

Location

Hospital Pulau Pinang-Pulau Pinang-21953

George Town, 10990, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30450, Malaysia

Location

Hospital Sultanah Aminah

Johor Bahru, 80100, Malaysia

Location

Hospital Sultan Ismail

Johor Bahru, 81100, Malaysia

Location

Queen Elizabeth Hospital

Kota Kinabalu, 88586, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Selayang

Kuala Selangor, 68100, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Pakar Sultanah Fatimah

Muar town, 84000, Malaysia

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

Southern Philippines Medical Center -Davao-62091

Davao City, 8000, Philippines

Location

Iloilo Doctors Hospital

Iloilo City, Iloilo, 5000, Philippines

Location

Center for Skin Research, Testing and Product Development

Makati City, 1229, Philippines

Location

SBHI Chelyabinsk Reg.Clin.Derma.Dispen.

Chelyabinsk, 454048, Russia

Location

LLC "Medical Center Azbuka Zdorovia"

Kazan', 420111, Russia

Location

FSBEI HE "Kirov State Medical University"

Kirov, 610035, Russia

Location

LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

Saint Petersburg, 190123, Russia

Location

Saratov State Med.Univ.n.a.Razumovskogo

Saratov, 410028, Russia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Hospital Sant Joan de Déu

Esplugues Del Llobregat, 08950, Spain

Location

Chang Gung Medical Foundation (CGMF) - Linkou Bran

Linkou District, 333, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Institute of Dermatology

Bangkok, 10400, Thailand

Location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Farhat Hached Hospital

Sousse, 4000, Tunisia

Location

La Rabta Hospital

Tunis, 1007, Tunisia

Location

Hedi Chaker Hospital, Department of Dermatology

Tunisia, 1053, Tunisia

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, 34890, Turkey (Türkiye)

Location

National Hospital of Dermatology and Venereology

Hà Nội, 10000, Vietnam

Location

HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092

Ho Chi Minh City, 70000, Vietnam

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 22, 2019
• Study Start: May 29, 2019
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): April 27, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2); AR (1); JP (4); US (2); BE (1); DE (7); MY (9); SG (1); CL (1); PH (3); FR (4); TU (3); ES (1); TW (2); RU (5); IT (1); ME (1); KR (1); CN (5); TH (2)