EUCTR2018-003080-56-BG进行中（未招募）1 期
An open-label, long term extension study to assess the safety andefficacy of BI 655130 treatment in patients with GeneralizedPustular Psoriasis (GPP)
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: 8
- •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.
- •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):
- •?- 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 all study visits/procedures or to complete the trial, compromise the safety of the patient or compromise the quality of the
- •12. Patients with a confirmed active infection with SARS-CoV-2 (as confirmed by PCR test). A patient may be enrolled once recovered from SARS-CoV-2 infection according to the investigator’s assessment.
研究者
相似试验
进行中（未招募）
2 期
A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130Generalized Pustular Psoriasis (GPP)JPRN-jRCT2041210087Taguchi Aya131
进行中（未招募）
1 期
A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130Generalized Pustular PsoriasisMedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858EUCTR2018-003080-56-ESBoehringer Ingelheim España S.A.150
进行中（未招募）
1 期
A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130EUCTR2018-003080-56-FRBoehringer Ingelheim France101
进行中（未招募）
3 期
A long-term study of beta-glucuronidase enzyme replacement therapy for Sly diseaseMucopolysaccharidosis type VIIMucopolysaccharidosis VII, Sly syndrome, beta-glucuronidase, vestronidase alfaD016538JPRN-jRCT2051190085Hamazaki Takashi4
未知
3 期
ong-Term Extension Study of Lu AA21004 in Participants with Major Depressive DisorderJPRN-jRCT2080221491Takeda Pharmaceutical Company Limited100