JPRN-jRCT2071210127进行中（未招募）未知
Multi-centre, open-label, expanded access trial of spesolimab i.v. in patients with generalized pustular psoriasis (GPP) presenting with a flare
Ohno Masashi0 个研究点目标入组 3 人开始时间: 2022年2月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1.Diagnosis of GPP confirmed based on the JDA guidelines for the management and treatment of GPP.
- •2.Patient is experiencing a flare, defined as new or worsening of widespread eruption of sterile macroscopically visible pustules, with or without systemic inflammation, as assessed by the investigator.
- •3.Male or female patients, aged 18 to 75 years at time of enrollment. Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method 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 the patient information.
- •4.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •5.No satisfactory authorised alternative therapy exists, as assessed by the investigator.
排除标准
- •1.Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Women who stop nursing before study drug administration do not need to be excluded from participating; they should refrain from breastfeeding for 16 weeks after the last spesolimab infusion.
- •2.Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold ULN elevation in AST or ALT or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin.
- •3.Active systemic infections (fungal and bacterial disease) during the last 2 weeks prior to drug administration, as assessed by the investigator.
- •4.Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation), as assessed by the investigator.
- •5.Relevant chronic or acute infections, including active tuberculosis (TB), HIV infection or viral hepatitis at the time of drug administration.
- •a)Patients should be evaluated for TB infection prior to initiating treatment with spesolimab.
- •b)Anti-TB therapy should be considered, in accordance with local guidelines, prior to initiating spesolimab in patients with latent TB or a history of TB.
- •6.History of allergy / hypersensitivity to systemically administered spesolimab or its excipients.
- •7.Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •8.Immediate life-threatening flare of GPP requiring intensive care treatment according to the investigator's judgement. Life-threatening complications include cardiovascular / cytokine driven shock, pulmonary distress syndrome, or renal failure.
研究者
相似试验
进行中（未招募）
1 期
Pilot decentralized clinical trial in men and Pre and Post-menopausal women with breast cancer and a specific mutation (PIK3CA) treated with alpelisib in combination with fulvestrantHR-positive/HER2-negative advanced breast cancer with a PIK3CA mutationMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2020-005882-15-SEovartis Pharma AG20
进行中（未招募）
1 期
An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF studyCrohn's diseaseEUCTR2006-004784-58-GBniversity of Leuven Hospitals25
进行中（未招募）
1 期
Safety and efficacy study of INC424 in patients with myelofibrosisEUCTR2010-024473-39-PLovartis Pharma Services AG2,500
进行中（未招募）
1 期
Safety and efficacy study of INC424 in patients with myelofibrosisEUCTR2010-024473-39-HUovartis Pharma Services AG2,500
进行中（未招募）
1 期
An open-label, multicenter, expanded access study of oral AMN 107 in adult patients with Imatinib (Glivec®/Gleevec®) - resistant or - intolerant chronic myeloid leukemia in blast crisis, accelerated phase or chronic phase - NACML in accelerated phase, blast crisis and chronic phaseEUCTR2005-001818-41-GBovartis Pharma Services AG