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Tests treatment safety and results for Allergic Asthma
Official title Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
ClinicalTrials.gov ID: NCT07342803
What this study is testing
What is LP-003 Injection?
LP-003 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for allergic asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)"...
- Positive bronchial dilation test within 24 months prior to screening or at the time of screening;
- people with at least one positive skin prick test or positive serum specific IgE test result for a relevant allergen within 12 months prior to...
You likely can't join if
- 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...
- Patients who have severe or uncontrolled diseases of the liver, kidneys, gastrointestinal tract, cardiovascular and cerebrovascular systems...
- 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...
- Known parasitic infection within 6 months prior to randomization;
See the full eligibility 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...
- Positive bronchial dilation test within 24 months prior to screening or at the time of screening;
- people 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;
- people 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...
- 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...
- At screening, 40% \< FEV1 \< 80% of predicted value;
- people who have no plans for pregnancy and agree to take effective contraceptive measures during the trial and for 6 months after the last dose of study treatment;
- people who voluntarily sign the ICF, are able to understand and correctly fill out the assessment form, correctly use the PEF device and record the patient diary card, and attend follow-up visits as scheduled.Male or...
- 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...
- 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...
- 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 ;
- Positive test for human immunodeficiency virus (HIV) antibodies at screening, or positive for treponema pallidum antibodies (except RPR or TRUST negative), or positive for hepatitis B surface antigen (except HBV-DNA...
- Still smoking or having quit smoking for less than 6 months at screening, or a history of smoking ≥10 pack-years [Smoking Index (pack-years) = daily smoking amount (packs) × smoking duration (years), 1 pack = 20...
- Used biological agents such as monoclonal antibodies, including investigational biological agents, within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer);
- Received systemic immunosuppressants or systemic glucocorticoids (dose equivalent to prednisone \>10 mg/day) for inflammatory or autoimmune diseases (such as rheumatoid arthritis, inflammatory bowel disease, systemic...
- Specific allergen immunotherapy conducted within 3 months prior to screening;
- Live (attenuated) virus/bacterial vaccines administered or intravenous immunoglobulin used within 4 weeks prior to screening;
- Participation in other drug clinical trials within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening;
- History of drug abuse, substance abuse, and/or excessive alcohol consumption within 1 year prior to screening;
- Pregnant or breastfeeding women;
- Any other condition that makes the subject unsuitable for participation in the trial as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.