2024-514764-72-00招募中3 期
A Phase 3, Randomized, Double-Blind, Parallel Group, Multicentre Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, immunogenicity, of BP11 versus EU-Approved Xolair in patients With Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 474
- 试验地点
- 59
- 主要终点
- Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12
研究概览
简要总结
To demonstrate therapeutic equivalence between BP11 and Xolair in patients with chronic spontaneous urticaria (CSU) with an inadequate response to H1 antihistamine (H1AH) treatment
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
- •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
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
- •History of and/or current disease as defined in the protocol
- •Proof of a COVID-19 vaccination within the 2 weeks before randomization
- •History of and/or an ongoing use of medications as defined in the protocol
- •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.
结局指标
主要结局
Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12
Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12
次要结局
- Change from Baseline in weekly Urticaria Activity Score (UAS7) at Weeks 2, 4, 8, 12, 16, 20, and 24
- Laboratory parameters (hematology, serum chemistry, and urinalysis) throughout the study
- Change from Baseline in ISS7 at Weeks 2, 4, 8, 16, 20, and 24
- Percentage of patients with UAS7 of ≤6 at Weeks 2, 4, 8, 12, 16, 20, and 24
- Percentage of complete responders (UAS7 = 0) in UAS7 at Weeks 2, 4, 8, 12, 16, 20, and 24
- Change from Baseline in weekly Hives Severity Score (HSS7) at Weeks 2, 4, 8, 12, 16, 20, and 24
- Change from Baseline in the overall Dermatology Life Quality Index (DLQI) score at Weeks 4, 8, 12, 16, 20, and 24
- Use of rescue medication up to scheduled efficacy time points and over the study (at Weeks 2, 4, 8, and 12, and by treatment period)
- Incidence, nature, and severity of adverse events (AEs) including adverse drug reactions graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 as defined by treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), related TEAEs, and related SAEs during Treatment Period 1 (TP1) and Treatment Period 2 (TP2)
- Injection-site and hypersensitivity reactions at Baseline (Week 0 after first study drug dose) and at Weeks 4, 8, 12, 16, and 20, and throughout the study
- Physical examinations, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study
- Incidence of antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) and ADA titers to omalizumab measured during TP1 at Baseline (Week 0) and at Weeks 4 and 12
- Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 at Weeks 20, 24, and 40
- Trough serum concentration (Ctrough) of omalizumab during TP1 at Baseline and at Weeks 4 and 12
- Trough serum concentration (Ctrough) of omalizumab during TP2 at Weeks 20, 24, and 40
- Total IgE and free IgE levels in serum during TP1 at Baseline (Week 0) and at Weeks 4 and 12
- Total IgE and free IgE levels in serum during TP2 at Weeks 20, 24, and 40
- Incidence, nature, and severity of AEs including adverse drug reactions graded according to the NCI CTCAE v5.0 as defined by TEAEs, SAEs, AESIs, related TEAEs, and related SAEs during TP2 for patients who switch treatment
- Injection-site and hypersensitivity reactions during TP2 for patients who switch treatment
- Physical examinations, vital signs, and 12-lead ECGs during TP2 for patients who switch treatment
- Laboratory parameters (hematology, clinical chemistry, and urinalysis) during TP2 for patients who switch treatment
- Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 for patients who switch treatment
研究者
Arpitkumar Prajapati
Scientific
Curateq Biologics Private Limited
研究点 (59)
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