Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
ConditionAllergic Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLongbio Pharma
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LP-003 Injection
- Omalizumab
- Placebo
Treatment groups
200 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov