Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
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| ClinicalTrials.gov Identifier: NCT03886246 |
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Recruitment Status :
Active, not recruiting
First Posted : March 22, 2019
Last Update Posted : January 5, 2024
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Generalized Pustular Psoriasis | Drug: Spesolimab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 131 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 27, 2019 |
| Estimated Primary Completion Date : | September 30, 2027 |
| Estimated Study Completion Date : | January 20, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Generalized pustular psoriasis
MedlinePlus related topics:
Psoriasis
Drug Information
available for:
Spesolimab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Spesolimab (every 6 weeks) |
Drug: Spesolimab
Solution for infusion Drug: Spesolimab Solution for injection |
| Experimental: Spesolimab (every 12 weeks) |
Drug: Spesolimab
Solution for injection |
| Experimental: Spesolimab (every 4 weeks) |
Drug: Spesolimab
Solution for injection |
Primary Outcome Measures :
- Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment [ Time Frame: Up to 252 Weeks ]
Secondary Outcome Measures :
- The reoccurrence of a GPP flare defined by GPPGA [ Time Frame: Up to 252 Weeks ]The total GPPGA score ranges from 0 to 4 with a higher score indicating a higher grade of inflammation.
- Time to first achievement of a GPPGA score of 0 or 1 (Patients received flare rescue Treatment) [ Time Frame: Up to 252 Weeks ]
- A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit [ Time Frame: Up to 252 Weeks ]
- Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit [ Time Frame: Up to 252 Weeks ]The PSS score ranges from None to Very Severe with a higher score indicating a higher severity of psoriasis symptom.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886246
Locations
Show 56 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT03886246 |
| Other Study ID Numbers: |
1368-0025 2018-003080-56 ( EudraCT Number ) |
| First Posted: | March 22, 2019 Key Record Dates |
| Last Update Posted: | January 5, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication. |
| Access Criteria: | For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'. |
| URL: | https://www.mystudywindow.com/msw/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |