Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients (NCT07342803) | Clinical Trial Compass
RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
China200 participantsStarted 2025-01-25
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years and ≤ 75 years, no gender restriction;
✓. Body weight ≥ 40 kg;
✓. Diagnosed with bronchial asthma for at least 1 year according to the "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)", and diagnosed with allergic asthma according to the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Asthma (2019 Edition)" ; At least 1 asthma exacerbation in the year prior to screening (referring to GINA and Chinese guidelines, asthma exacerbation is defined as worsening of asthma symptoms requiring systemic glucocorticoid treatment for at least 3 days, and/or multiplying the dose of inhaled glucocorticoids for at least 3 days);
✓. Positive bronchial dilation test within 24 months prior to screening or at the time of screening;
✓. Subjects with at least one positive skin prick test or positive serum specific IgE test result for a relevant allergen within 12 months prior to randomization;
✓. Subjects who have received medium to high dose inhaled corticosteroids (ICS) treatment for at least 8 weeks prior to screening (fluticasone propionate \>250 μg/day or equivalent dose of ICS, not exceeding fluticasone propionate 2000 μg/day or equivalent dose of ICS, as per the "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)"), have maintained stable use for 4 weeks before randomization, with asthma remaining partially controlled or uncontrolled (defined as ACT score ≤ 19);
✓. Combined with at least one other asthma control medication (long-acting β2 receptor agonists (LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), and sustained-release theophylline treatment) and stable use for 4 weeks before randomization ;
✓. At screening, 40% \< FEV1 \< 80% of predicted value;
Exclusion criteria
What they're measuring
1
Mean number of asthma exacerbations per subject
Timeframe: During the 24-week treatment period
2
Proportion of subjects with asthma exacerbations
Timeframe: During the 24-week treatment period
3
Mean number of asthma exacerbations per subject
Timeframe: During the 36-week and 48-week follow-up period
4
Proportion of subjects with asthma exacerbations
Timeframe: During the 36-week and 48-week follow-up period
5
Proportion of subjects with loss of asthma control (LOAC) in each group
Timeframe: During the 24-week treatment period
6
Incidence of adverse events (AEs)
Timeframe: Up to approximately 52 weeks
7
Change from baseline in pre-bronchodilator FEV1, FVC, and FEV1/FVC ratio
Timeframe: Weeks 4, 8, 12, 16, 20, and 24
8
Change from baseline in weekly mean daily and weekly Peak Expiratory Flow (PEF) variability, and change from baseline in mean PEF
✕. Allergic to the investigational product and its excipients or Xolair® ;
✕. Coexisting diseases other than asthma that may affect lung function, such as chronic obstructive pulmonary disease (COPD), allergic bronchopulmonary aspergillosis (ABPA), and bronchiectasis, which, in the investigator's judgment, may place the subject at inappropriate risk or affect the assessment of study results;
✕. Patients who have severe or uncontrolled diseases of the liver, kidneys, gastrointestinal tract, cardiovascular and cerebrovascular systems, hematopoietic system, urogenital system, endocrine system, nervous system, immune system, etc.;
✕. Clinically significant infection history within 4 weeks prior to randomization, as assessed by the investigator, affecting patient evaluation;
✕. Major surgery within 4 weeks prior to randomization or planned surgical procedures during the study period, or treatments that the investigator believes may affect patient evaluation;
✕. Known parasitic infection within 6 months prior to randomization;
✕. History of malignancy diagnosed within 5 years prior to screening;
✕. Clinically significant abnormalities in laboratory tests during the screening period and baseline, deemed unsuitable for participation by the investigator ;
Timeframe: Weeks 4, 8, 12, 16, 20, and 24
9
Time to first asthma exacerbation from baseline
Timeframe: Up to approximately 52 weeks
10
Change from baseline in weekly use of reliever medication (Salbutamol Sulfate Aerosol)
Timeframe: Up to approximately 52 weeks
11
Change from baseline in weekly Asthma Symptom Diary Score
Timeframe: Up to approximately 52 weeks
12
Change from baseline in standardized Asthma Quality of Life Questionnaire (AQLQ(S))
Timeframe: Weeks 12 and 24
13
Change from baseline in Asthma Control Questionnaire (ACQ-5)
Timeframe: Weeks 12 and 24
14
Change from baseline in Asthma Control Test (ACT)
Timeframe: Weeks 12 and 24
15
Change in serum free IgE levels over time at different time points
Timeframe: Up to approximately 52 weeks
16
Serum concentrations of LP-003 at different time points