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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • LP-003 Injection

    Biological/Vaccine

    s.c. injection, Q12W

  • Omalizumab

    Biological/Vaccine

    s.c. injection, Q4W

  • Placebo

    Biological/Vaccine

    s.c. injection, Q4W

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: LP-003 150 mg groupExperimental treatment 2 interventions
Group B: LP-003 300 mg groupExperimental treatment 2 interventions
Group C: LP-003 450 mg groupExperimental treatment 2 interventions
Group D: Omalizumab groupActive comparator 1 intervention
Group E: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean number of asthma exacerbations per subject

Time frame
During the 24-week treatment period
2

Proportion of subjects with asthma exacerbations

Time frame
During the 24-week treatment period
3

Mean number of asthma exacerbations per subject

Time frame
During the 36-week and 48-week follow-up period
4

Proportion of subjects with asthma exacerbations

Time frame
During the 36-week and 48-week follow-up period

Secondary outcomes

1

Change from baseline in Fractional exhaled Nitric Oxide (FeNO)

Time frame
Weeks 4, 8, 12, 16, 20, and 24
2

Change from baseline in blood eosinophil count (EOS)

Time frame
Weeks 4, 8, 12, 16, 20, and 24
3

Change in serum total IgE levels over time at different time points

Time frame
Up to approximately 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Longbio Pharma

Lead sponsor

Source ClinicalTrials.gov
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