A 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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 14
- 主要终点
- Change from Baseline in weekly Itch Severity Score (ISS7) and
研究概览
简要总结
Chronic spontaneous urticaria (CSU) is defined as a severe and distressing skin condition characterized by red, swollen, itchy, and sometimes painful wheals (hives) on the skin with an unknown or autoimmune trigger that are present on most days of the week for at least 6 weeks.
Omalizumab (Xolair®) is a recombinant humanized anti-immunoglobulin E (IgE) monoclonal antibody. Xolair binds to free IgE and reduces the levels of free IgE and its high-affinity receptor FcεRI, both of which are essential in mast cell and basophil activation. It has not yet been fully elucidated how this results in CSU improvement. However, as per Kaplan et al,7 potential mechanisms in CIU/CSU include reducing mast cell releasability, reversing basopenia and improving basophil IgE receptor function, reducing activity of IgG autoantibodies against FcεRI and IgE, reducing activity of IgE autoantibodies against an antigen or autoantigen that has yet to be definitively identified, reducing the activity of intrinsically “abnormal†IgE, and decreasing in vitro coagulation abnormalities associated with disease activity.
This is a phase 3, randomized, double-blind, parallel-group, multicentre 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients 18 to 60 years of age (inclusive) willing and able to provide informed consent.
- •A diagnosis of CSU for at least 6 months 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.
- •Willing and able to complete an e-diary twice daily (morning and evening) up to 24 weeks
- •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.
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.
- •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.
结局指标
主要结局
Change from Baseline in weekly Itch Severity Score (ISS7) and
时间窗: Week 12
Relative potency based on change from Baseline in ISS7
时间窗: Week 12
次要结局
- Efficacy(Various time points from baseline to week 24)
- safety and tolerability(Throughout study duration)
- Immunogenicity(Various time points from baseline (week 0) to week 40)
- Pharmacokinetics(Various time points from baseline (week 0) to week 40)
- Pharmacodynamics(Various time points from baseline (week 0) to week 40)