Generalized Pustular PsoriasisPhase 2NCT03886246
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
A Phase 2 study testing Spesolimab in people with Generalized Pustular Psoriasis, run by LEO Pharma at 58 sites in 21 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Generalized Pustular Psoriasis
- What is being tested?
- Spesolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 58 sitesin 21 countries
- Study dates
- 29 May 2019to 27 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
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- 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.
Trial locations and contacts
58 sites in 21 countries.
58 sites in 21 countries
Malaysia9 sites
Hospital Pulau Pinang-Pulau Pinang-21953
George Town, 10990
Hospital Raja Permaisuri Bainun
Ipoh, 30450
Hospital Sultanah Aminah
Johor Bahru, 80100
Hospital Sultan Ismail
Johor Bahru, 81100
Queen Elizabeth Hospital
Kota Kinabalu, 88586
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Hospital Selayang
Kuala Selangor, 68100
Sarawak General Hospital
Kuching, Sarawak, 93586
Hospital Pakar Sultanah Fatimah
Muar town, 84000
Germany8 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
Charité - Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Bonn AöR
Bonn, 53127
Universitätsklinikum Erlangen
Erlangen, 91054
Universitätsklinikum Frankfurt
Frankfurt am Main, 60596
Klinikum der Universität München - Campus Innenstadt
München, 80337
Westfälische Wilhelms-Universität Münster
Münster, 48149
Klinikum Oldenburg AöR
Oldenburg, 26133
China5 sites
Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
Guangzhou, 510288
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
Shanghai Skin Disease Hospital
Shanghai, 200000
Huashan Hospital, Fudan University
Shanghai, 200040
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an, 710004
Russia5 sites
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
Chelyabinsk, 454048
LLC "Medical Center Azbuka Zdorovia"
Kazan', 420111
FSBEI HE "Kirov State Medical University"
Kirov, 610035
LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg
Saint Petersburg, 190123
Saratov State Med.Univ.n.a.Razumovskogo
Saratov, 410028
France4 sites
HOP Saint-André
Bordeaux, 33000
Hôpital de l'Archet
Nice, 06200
HOP Saint-Louis
Paris, 75010
HOP Robert Debré
Reims, 51092
Japan4 sites
Nagoya City University Hospital
Aichi, Nagoya, 467-8602
Tokyo Medical University Ibaraki Medical Center
Ibaraki, Inashiki-gun, 300-0395
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Tokyo Medical University Hachioji Medical Center
Tokyo, Hachioji, 193-0998
Philippines3 sites
Southern Philippines Medical Center -Davao-62091
Davao City, 8000
Iloilo Doctors Hospital
Iloilo City, Iloilo, 5000
Zenith Skin Science Center Inc.
Makati City, 1229
Tunisia3 sites
Hedi Chaker Hospital, Department of Dermatology
Sfax, 1053
Farhat Hached Hospital
Sousse, 4000
La Rabta Hospital
Tunis, 1007
United States2 sites
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Taiwan2 sites
Chang Gung Medical Foundation (CGMF) - Linkou Bran
Linkou District, 333
National Taiwan University Hospital
Taipei, 10002
Thailand2 sites
Institute of Dermatology
Bangkok, 10400
Ramathibodi Hospital
Bangkok, 10400
Vietnam2 sites
National Hospital of Dermatology and Venereology
Hà Nội, 10000
HCMC Hospital of Dermato-Venereology-Ho Chi Minh-66092
Ho Chi Minh City, 70000
Mexico1 site
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Turkey (Türkiye)1 site
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890
About this study
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)
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.
Read more
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
- Being tested
- Spesolimab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpesolimabDrug
Solution for infusion
SpesolimabDrug
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Spesolimab (every 6 weeks) | Experimental | Not described Receives: Drug: Spesolimab |
| Spesolimab (every 12 weeks) | Experimental | Not described Receives: Drug: Spesolimab |
| Spesolimab (every 4 weeks) | Experimental | Not described Receives: Drug: Spesolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Measured: Up to 252 Weeks
Secondary outcomes (4)
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.
Measured: Up to 252 Weeks
Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment)
Measured: Up to 252 Weeks
A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit
Measured: Up to 252 Weeks
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.
Measured: Up to 252 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start29 May 2019
- Primary completion30 Sep 2027 (estimated)
- Study completion27 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886246
- Sponsor's protocol ID
- 1368-0025
- Other IDs
- 2018-003080-56, 2023-509216-28-00, 2023, 2018
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2019
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No