JPRN-jRCT2080223838已完成3 期
A Phase III, Open-label, Multi-Center Study to Evaluate the long term Safety of nemolizumab in Japanese Atopic Dermatitis Patients with moderate to severe pruritus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
研究概览
简要总结
The study treatment was safe and well tolerated. Few clinically significant abnormalities of laboratory tests, vital signs or ECGs were noted in the study. The result of pruritus VAS indicated the improvement in AD until Week 52. The improvement tendency in AD continued after Week 52.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 13age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Atopic Dermatitis with moderate or severe pruritus patients
排除标准
- •- Patients with body weight <30.0kg
- •- Patients with Hepatitis B virus or hepatitis C virus infection
- •- Patients with Evidence of tuberculosis (TB) infection
- •- Patients with immune deficiency
- •- Pregnant or lactating women
研究者
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Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.Congenital adrenal hyperplasia (CAH)is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000012082EUCTR2015-000711-40-DKDiurnal Ltd120
进行中（未招募）
1 期
Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness.Congenital adrenal hyperplasia (CAH)is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence.MedDRA version: 20.0Level: LLTClassification code 10010323Term: Congenital adrenal hyperplasiaSystem Organ Class: 100000012082EUCTR2015-000711-40-SEDiurnal Ltd120