EUCTR2018-003080-56-FR进行中（未招募）1 期
An open-label, long term extension study to assess the safety and efficacy of BI 655130 treatment in patients with Generalized Pustular Psoriasis (GPP)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
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
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? no
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •. 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
- •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 re-screened if the patient was treated and is cured from
- •acute infection.
- •6. Active or Latent tuberculosis (TB):
- •If the result of QuantiFERON® TB test is positive, the patient may participate in the
- •current study if further work up (according to local practice/guidelines) establishes
- •conclusively that the patient has no evidence of active TB. Active TB patients must be
- •excluded. If presence of latent tuberculosis is established, then treatment should be
- •initiated and maintained according to local country guidelines.
- •If QuantiFERON® TB test provides indeterminate results after repeat testing: A
- •tuberculin skin test reaction =10mm (=5mm if receiving =15mg/d prednisone or its
- •equivalent).
- •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 all study visits/procedur
研究者
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