CTRI/2022/12/048623已完成3 期
A Multinational, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizumab (XOLAIR®) in Patients With Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria who Remain Symptomatic Despite Antihistamine (H1) Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
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
入选标准
- •Diagnosis of CIU refractory to H1 antihistamines for =3 months.
排除标准
- •Chronic urticaria with clearly defined underlying etiology
- •Other skin disease associated with itch
- •Evidence of parasitic infection on stool evaluation for ova and parasites
- •History of anaphylactic shock
- •Hypersensitivity to omalizumab or any component of the formulation
- •Required background therapy with other than protocol-defined antihistamines
- •Any medical condition that could jeopardize or would compromise the patient safety or ability to participate in this study
研究者
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