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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-003 group 1 | Experimental | Participants received LP-003 subcutaneously during the 24-week treatment period |
|
| LP-003 group 2 | Experimental | Participants received LP-003 subcutaneously during the 24-week treatment period |
|
| LP-003 group 3 | Experimental | Participants received LP-003 subcutaneously during the 24-week treatment period |
|
| Omalizumab | Active Comparator | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24-week treatment period |
|
| Placebo | Placebo Comparator | Participants received placebo subcutaneously every 4 weeks during the 24-week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 | Biological | Liquid in vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events during the study | 40 weeks | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences |
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| Placebo | Biological | Liquid in vial |
|
| Omalizumab | Biological | Liquid in vial |
|
| 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 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 |
| 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 |
| 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 |
| 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 |
| Beijing |
| Beijing Municipality |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of China Medical University | Beijing | Beijing Municipality | China |
| The First Hospital of Peking University | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of PLA Army Medical University | Chongqing | Chongqing Municipality | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| The Second XiangYa Hospital of Central South University | Changsha | Hunan | China |
| Hospital of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College | Nanjing | Jiangsu | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| the Second Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | China |
| Hangzhou First People's Hospital | Hangzhou | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | China |
| Wuhan NO.1 Hospital | Wuhan | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | China |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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