NCT06228560已完成2 期
Multi-center,Randomized,Double-blind Phase II Study to Evaluate the Efficacy and Safety of LP-003 in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Longbio Pharma20 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年1月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 20
- 主要终点
- The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12
研究概览
简要总结
The study is a Phase II, multicenter, randomized, double-blind study to evaluatethe efficacy and safety of LP-003 administered subcutaneously as an add-on therapy for the treatment of adult patients aged 18-75 who have been diagnosed with refractory CSU and who remain symptomatic despitestandard-dose H1 antihistamine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years at the screening period.
- •Presence of wheals with itching for ≥ 6 weeks prior to randomization. At the screening visit, subjects had taken double or more than the approved dose, or a combination of two or more H1 antihistamines for the treatment of chronic spontaneous urticaria for at least 2 weeks. Within the 7 days preceding randomization, the Urticaria Activity Score 7 (UAS7) was ≥16 (range 0-42), Itch Severity Score 7 (ISS7) was ≥8 (range 0-21), at least one UAS (range 0-6) was ≥4 on any screening visit day, and there must be a current record of medication use.
- •Subjects must not miss more than one diary record (morning or night) within 7 days prior to randomization (day 1), and are willing and able to complete daily symptom electronic diary records during the study period;
- •Male participants and their partners or female participants must agree to take one or more non pharmacological contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial period and within 6 months after the end of the trial and have no plans for sperm or egg donation.
- •Agree to participate in this clinical trial and voluntarily sign an informed consent form.
排除标准
- •The subject has a primary or sole trigger for chronic urticaria (chronic Induced urticaria), including artificial urticaria (symptomatic skin scratch disease), cold, heat, sun, pressure, delayed pressure, water, cholinergic, or contact urticaria;
- •Other medical conditions accompanied by symptoms of urticaria or angioedema including, but not limited to, urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria;
- •Any other dermatologic condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the judgment of the Investigator may affect the evaluation of the study and the results of the study;
- •Subjects with clinically significant conditions such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, cardiac arrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative, or other neurological disorders, uncontrolled hypothyroidism and hyperthyroidism and other autoimmune disorders, hypokalemia, hyper adrenergic state; past diagnosis of malignancy (other than basal cell carcinoma or squamous cell skin cancer); history of myocardial infarction within 12 months prior to screening;
- •Acute active infections requiring treatment at screening, including but not limited to, pulmonary infections, tuberculosis;
- •Positive hepatitis B surface antigen or hepatitis B core antibody (except for HBV-DNA testing below the lower limit of the research center's test) at screening; positive hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, and anti-syphilis helical antibody (TP-Ab) (except for those who are negative for RPR or TRUST);
- •Clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other abnormalities identified during the Screening Period that may affect the interpretation of the study results and/or the safety of the subject;
- •Comorbid neurological or psychiatric disorders that prevent or prevent cooperation; patients with disabilities as defined by law (blindness, deafness, mute, mental retardation, psychiatric disorders, etc.);
- •Major surgery within 8 weeks prior to screening or surgery planned during the study period;
- •Evidence of historical or ongoing alcohol or substance abuse in the 6 months prior to screening;
- •Poor compliance, such as low medication adherence, inability to accurately complete a diary card, or use of prohibited medications;
- •Pregnant women, nursing mothers, or those with recent birth plans;
- •Patients who have participated in clinical trials of other drugs within the last 3 months;
- •Those who are considered by the investigator to be unfit to participate in the clinical trial.
研究组 & 干预措施
LP-003 group 1
Experimental
Participants received LP-003 subcutaneously during the 24-week treatment period
干预措施: LP-003 (Biological)
LP-003 group 2
Experimental
Participants received LP-003 subcutaneously during the 24-week treatment period
干预措施: LP-003 (Biological)
LP-003 group 3
Experimental
Participants received LP-003 subcutaneously during the 24-week treatment period
干预措施: LP-003 (Biological)
Omalizumab
Active Comparator
Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24-week treatment period
干预措施: Omalizumab (Biological)
Placebo
Placebo Comparator
Participants received placebo subcutaneously every 4 weeks during the 24-week treatment period
干预措施: Placebo (Biological)
结局指标
主要结局
The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12
时间窗: Week 12
次要结局
- The proportion of participants with controlled disease activity (UAS7 ≤ 6) at week 4, 8, 12, 16, 20, 24, 32, and 40(Week 4, 8, 12, 16, 20, 24, 32, and 40)
- The proportion of participants achieving complete absence of angioedema (AAS7 = 0) at week 4, 8, 12, 16, 20, 24, 32, and 40(Week 4, 8, 12, 16, 20, 24, 32, and 40)
- Change From Baseline in UAS7, HSS7, ISS7, AAS7 at week 4, 8, 12, 16, 20, 24, 32, and 40(Baseline and week 4, 8, 12, 16, 20, 24, 32, and 40)
- The proportion of participants with no hives (HSS7 = 0) at week 4, 8, 12, 16, 20, 24, 32, and 40(Week 4, 8, 12, 16, 20, 24, 32, and 40)
- The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 4, 8, 16, 20, 24, 32, and 40(Week 4, 8, 16, 20, 24, 32, and 40)
- The incidence of adverse events during the study(40 weeks)
- Change From Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) at week 4, 8, 12, 16, 20, 24, 32, and 40(Baseline and week 4, 8, 12, 16, 20, 24, 32, and 40)
- Blood concentrations of LP-003, free IgE, total IgE, anti-drug antibodies (ADA), and neutralizing antibodies (Nab) during the study(40 weeks)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)Bacterial InfectionsInfectionNCT01119105Nabriva Therapeutics AG210
招募中
2 期
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian CancerOvarian Cancer RecurrentNCT06014528InxMed (Shanghai) Co., Ltd.168
Unknown
2 期
Phase II Study in the Treatment of Patients With Advanced Mucinous MelanomaAdvanced Mucosal MelanomaNCT03941795Peking University Cancer Hospital & Institute99
招募中
2 期
A Phase 2 Study of HB0017 in Psoriasis PatientsPsoriasis (PsO)NCT06592274Huabo Biopharm Co., Ltd.200
终止
2 期
A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive LabelNon-small Cell Lung CancerNCT02318368AVEO Pharmaceuticals, Inc.10
相关资讯
LongBio's LP-003 Demonstrates Superior Efficacy Over Xolair in Phase II Chronic Urticaria Trial- LongBio announced positive Phase II results showing LP-003, a next-generation anti-IgE antibody, achieved statistically superior efficacy compared to Xolair (omalizumab) in treating chronic spontaneous urticaria.
- The 202-patient trial demonstrated LP-003's 200 mg Q8W dose achieved 66.7% complete remission rate versus 43.6% for Xolair at Week 12, with statistical significance (p=0.0405).
- LP-003 showed faster onset of action with 35%-35.9% complete remission rates by Week 4 across treatment groups and exhibited a favorable safety profile.
- The company plans to submit a Biologics License Application to China's NMPA for seasonal allergic rhinitis by Q3 2026, potentially becoming the first innovative anti-IgE drug launched globally in over 20 years.6 months agoNovel Anti-IgE Antibody LP-003 Shows Superior Efficacy Over Omalizumab in Chronic Spontaneous Urticaria Trial- Longbio's LP-003 demonstrated superior improvement in UAS7 scores compared to Omalizumab at weeks 4 and 12 in Phase II trial for Chronic Spontaneous Urticaria treatment.
- The novel long-acting anti-IgE antibody showed rapid symptom relief with a favorable safety profile and extended dosing interval of up to 8 weeks, potentially offering better treatment convenience.
- Results position LP-003 as a potential best-in-class therapy in the growing CSU market, with comparable efficacy to barzolvolimab and plans for expansion into food allergy and asthma indications.last year