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This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-003 150 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
|
| LP-003 300 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
|
| LP-003 450 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
|
| Omalizumab group | Active Comparator | Participants received subcutaneous injection of Omalizumab every 4 weeks; the dose was determined by baseline IgE level and body weight, with a maximum dose 600 mg. |
|
| Placebo group | Placebo Comparator | Participants received subcutaneous injection of Placebo every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 Injection | Biological | s.c. injection, Q12W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of asthma exacerbations per subject | During the 24-week treatment period | |
| Proportion of subjects with asthma exacerbations | During the 24-week treatment period | |
| Mean number of asthma exacerbations per subject | During the 36-week and 48-week follow-up period | |
| Proportion of subjects with asthma exacerbations | During the 36-week and 48-week follow-up period | |
| Proportion of subjects with loss of asthma control (LOAC) in each group | During the 24-week treatment period | |
| Incidence of adverse events (AEs) | Up to approximately 52 weeks | |
| Change from baseline in pre-bronchodilator FEV1, FVC, and FEV1/FVC ratio | Weeks 4, 8, 12, 16, 20, and 24 | |
| Change from baseline in weekly mean daily and weekly Peak Expiratory Flow (PEF) variability, and change from baseline in mean PEF | Weeks 4, 8, 12, 16, 20, and 24 | |
| Time to first asthma exacerbation from baseline | Up to approximately 52 weeks | |
| Change from baseline in weekly use of reliever medication (Salbutamol Sulfate Aerosol) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fractional exhaled Nitric Oxide (FeNO) | Weeks 4, 8, 12, 16, 20, and 24 | |
| Change from baseline in blood eosinophil count (EOS) | Weeks 4, 8, 12, 16, 20, and 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Yang | Contact | +86 021-58372390 | yangj@longbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieming Qu | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Omalizumab | Biological | s.c. injection, Q4W |
|
| Placebo | Biological | s.c. injection, Q4W |
|
| Up to approximately 52 weeks |
| Change from baseline in weekly Asthma Symptom Diary Score | Up to approximately 52 weeks |
| Change from baseline in standardized Asthma Quality of Life Questionnaire (AQLQ(S)) | The AQLQ(S) is a validated patient-reported outcome (PRO) tool designed to assess the impact of asthma on patients' quality of life. This questionnaire consists of a total of 35 items, which are scored on a 7-point Likert scale (where 1 indicates the worst quality of life and 7 indicates the best quality of life). | Weeks 12 and 24 |
| Change from baseline in Asthma Control Questionnaire (ACQ-5) | The ACQ-5 is a tool for evaluating asthma control status. The questionnaire comprises 5 items, with the ACQ-5 score calculated as the mean score of the 5 items. A score of < 0.75 indicates complete asthma control, a score between 0.75 and 1.5 indicates well-controlled asthma, and a score of > 1.5 indicates uncontrolled asthma. | Weeks 12 and 24 |
| Change from baseline in Asthma Control Test (ACT) | The ACT is a tool for assessing asthma control status, comprising 5 questions with 5 response options each (scored 1 to 5 points per question). The total score is the sum of the 5 items, with the following criteria: 20-25 = well-controlled; 16-19 = inadequately controlled; 5-15 = very poorly controlled. | Weeks 12 and 24 |
| Change in serum free IgE levels over time at different time points | Up to approximately 52 weeks |
| Serum concentrations of LP-003 at different time points | Up to approximately 52 weeks |
| Incidence of Anti-drug Antibodies (ADA) | Up to approximately 52 weeks |
| Change in serum total IgE levels over time at different time points |
| Up to approximately 52 weeks |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |