CTIS2023-503600-83-00进行中（未招募）1 期
A Phase 3B, Multi Center, Open-label Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis - CC-10004-PPSO-004
Amgen Inc.0 个研究点目标入组 124 人开始时间: 2023年7月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
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
- 0 至 17（—）
- 性别
- All
入选标准
- •Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian., Subject must have a weight of = 20 kg., Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents (CDC, 2000)., Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003., Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
排除标准
- •Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study., Subject has a condition that confounds the ability to interpret data from the study., Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments., Subject is pregnant or breastfeeding., Subject has guttate, erythrodermic, or pustular psoriasis.
研究者
相似试验
进行中（未招募）
1 期
Apremilast study in children with active oral ulcers associated withBehçet's Disease or Juvenile Psoriatic ArthritisSubjects with active Behçet's Disease or Juvenile Psoriatic ArthritisMedDRA version: 21.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10079454Term: Systemic juvenile idiopathic arthritisSystem Organ Class: 100000004859EUCTR2022-003024-41-FRAmgen Inc
招募中
1 期
Phase 3, Open-label Apremilast Pediatric Long-term Extension Study in Children with Oral Ulcers Associated With Behçet’s Disease or Juvenile Psoriatic ArthritisCTIS2023-503433-21-00Amgen Inc.49
进行中（未招募）
1 期
Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic ArthritisSubjects with active Behçet's Disease or Juvenile Psoriatic ArthritisMedDRA version: 21.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10079454Term: Systemic juvenile idiopathic arthritisSystem Organ Class: 100000004859EUCTR2022-003024-41-ESAmgen Inc48
进行中（未招募）
1 期
Apremilast study in children with active oral ulcers associated withBehçet's Disease or Juvenile Psoriatic ArthritisSubjects with active Behçet's Disease or Juvenile Psoriatic ArthritisMedDRA version: 21.1Level: LLTClassification code 10004212Term: Behcet's diseaseSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10079454Term: Systemic juvenile idiopathic arthritisSystem Organ Class: 100000004859EUCTR2022-003024-41-GRAmgen Inc48
已完成
3 期
A Phase 3, Multicentre, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's DiseaseBowel Inflammation10017969Crohn's DiseaseNL-OMON54068Eli Lilly8