EUCTR2020-000189-41-HU进行中（未招募）1 期
An open-label, single arm, long term trial of Spesolimab treatment in patients with Palmoplantar Pustulosis (PPP) who have completed previous BI Spesolimab trials
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •- Signed and dated written informed consent for the current trial 1368-0024, in accordance
- •with ICH-GCP and local legislation prior to admission to the current trial
- •- Male or female patients who have completed the treatment period in one of the parent
- •trials without premature discontinuation
- •- Patients who have obtained an individual health benefit, per investigator judgement (e.g.
- •PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment
- •in the parent 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 4.2.3 and 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.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •- Patients who experienced study treatment-limiting adverse events during the parent trial.
- •- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- •- Patients with congestive heart disease, as assessed by the investigator.
- •- Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal).
- •- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly).
- •- Any documented active or suspected malignancy or history of 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.
- •- Patients who have developed active or severe infective disease and opportunistic infections/infective diseases.
- •-- Patients with latent TB during preceding trial are allowed to be included in study 1368-0024, provided they have received and/or receive currently appropriate treatment according to local guidelines.
- •- Further criteria apply
研究者
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