EUCTR2020-000189-41-DE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 within 5 years prior to screening in parental trial, 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.
- •- Presence of acute demyelinating neuropathy
- •- Further criteria apply
研究者
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