EUCTR2022-001745-20-BG招募中1 期
Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist - Efficacy, Safety, PD, PK, and Immunogenicity of BP11 Compared With Xolair
CuraTeQ Biologics Private Ltd.0 个研究点目标入组 600 人开始时间: 2023年4月3日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •- Male or female patients 18 to 75 years of age (inclusive) willing and able to provide informed consent
- •- A diagnosis of CSU for at least 6 months before randomization
- •- A diagnosis of CSU refractory to H1AH treatment as defined in the protocol
- •- A diagnosis of CSU refractory to H1AH treatment as defined in the protocol
- •- Able to provide patient e-diary entries (without missing data) for the last 7 consecutive days before randomization
- •- Patient must be willing to complete e-diary twice daily (morning and evening). Able to provide e-diary entries for at least 4 consecutive days out of 7 days before randomization.
- •- Females of childbearing potential (FOCBP) and males with a female partner of childbearing potential must be willing to use reliable contraceptive precautions (refer to Appendix 1 for details) throughout the study until 6 months after the last study treatment dose.
- •- If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits
- •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 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients
- •- Previous exposure to omalizumab (Xolair or biosimilar omalizumab)
- •- Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias
- •- Any of the following diseases, which may have symptoms of urticaria and/or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
- •- Proof of a COVID-19 vaccination within the 2 weeks before randomization
- •- Any contraindication to use of diphenhydramine
- •- Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites
- •- Current or history of drug or alcohol abuse within the past year based on the investigator’s judgment
- •- Contraindication to background therapy and/or rescue therapy with H1AHs or contraindication to epinephrine or other components of these agents as per the investigator’s discretion
- •- To ensure complete systemic elimination of the study drug, any female who is currently pregnant or breastfeeding or plans to become pregnant or breastfeed for 6 months after the last dose of assigned study treatment or any male who is planning to father a child or
- •donate sperm during the study period or for 6 months after the last dose of assigned study treatment
- •- Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients in the opinion of the investigator
- •- Inability to comply with the study and follow-up procedures
- •- History of and/or concomitant immune complex disease (including allergic reaction type III), hyperimmunoglobulin E syndrome, autoimmune disease (which impact the study objectives at the discretion of investigator), or bronchopulmonary aspergillosis.
- •- Active infection requiring treatment 4 weeks before Screening.
研究者
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