EUCTR2019-001227-12-NL进行中(未招募)1 期
A Phase 3b, open label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who successfully completed treatment in the M16-046 study - Heads UP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 600
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
- •Subjects should have successfully completed treatment in the M16-046 study, without developing any permanent discontinuation criteria.
- •Subject is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the M16-046 study to continue treatment in the long term extension study.
- •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 570
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study
研究者
相似试验
进行中(未招募)
1 期
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046 study. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completedModerate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2019-001227-12-IEAbbVie Deutschland GmbH & Co. KG485
进行中(未招募)
1 期
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046study. At the end of M16-046, they have the option to receive Upadacitinib until the investigational drug has been approved by the regulatory authorities in their country and/or applicable local reimbursement approval. There will be a 30 day follow-up visit after the treatment period is completedModerate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2019-001227-12-HUAbbVie Deutschland GmbH & Co. KG485
进行中(未招募)
1 期
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046 study. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completedModerate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2019-001227-12-HRAbbVie Deutschland GmbH & Co. KG600
进行中(未招募)
1 期
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046study. At the end of M16-046, they have the option to receive Upadacitinib until the investigational drug has been approved by the regulatory authorities in their country and/or applicable local reimbursement approval. There will be a 30 day follow-up visit after the treatment period is completedEUCTR2019-001227-12-FIAbbVie Deutschland GmbH & Co. KG485
进行中(未招募)
1 期
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the M16-046 study. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completedModerate to severe Atopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858EUCTR2019-001227-12-FRAbbVie Deutschland GmbH & Co. KG600
