EUCTR2018-003080-56-DE进行中（未招募）1 期
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) - Effisayil O
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients who have completed the treatment period without premature
- •discontinuation in the previous BI 655130 trial (1368-0013 or 1368-0027) and are willing
- •and able to continue treatment in the current trial
- •2. 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.
- •3. Signed and dated written informed consent for the current trial 1368-0025, in accordance
- •with ICH-GCP and local legislation prior to admission to the current trial
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1. Evidence of flare symptoms of moderate/severe intensity at screening
- •2. Treatment with any restricted medication as specified in Table
- •4.2.2.1:1, or any drugs considered by the investigator likely to interfere
- •with the safe conduct of the study since the last visit of the previous BI
- •651330 trial and during the screening period for the current trial, with exception of methotrexate, cyclosporine, or retinoids started following rescue treatment for GPP flare in trial 1368-0027.
- •3. Severe, progressive, or uncontrolled hepatic disease, defined as >3-
- •fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline
- •phosphatase, or >2-fold ULN elevation in total bilirubin.
- •4. Patients with congestive heart disease, as assessed by the
- •investigator.
- •5. Relevant chronic or acute infections including human
- •immunodeficiency virus (HIV) or viral hepatitis. A patient can be rescreened
- •if the patient was treated and is cured from acute infection.
- •6. 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.
- •7. History of allergy/hypersensitivity to a systemically administered trial
- •medication agent or its excipients.
- •8. 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.
- •9. Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial. Women who stop nursing before the study drug
- •administration do not need to be excluded from participating; they
- •should refrain from breastfeeding up to 16 weeks after the study drug
- •administration (see Section 4.2.2).
- •10. Major surgery (major according to the investigator's assessment)
- •performed since the last visit of previous BI 655130 trial or planned
- •during the current trial, e.g. hip replacement, aneurysm removal,
- •stomach ligation), as assessed by the investigator.
- •11. Evidence of a current or previous disease, medical condition
- •(including chronic alcohol or drug abuse or any condition) other than
- •GPP, surgical procedure, psychiatric or social problems, medical
- •examination finding (including vital signs and electrocardiogram [ECG]),
- •or laboratory value at the screening outside the reference range that in
- •the opinion of the investigator is clinically significant and would make
- •the study participant unreliable to adhere to the protocol, comply with
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研究者
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