Actively Recruiting
A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.
Led by Longbio Pharma · Updated on 2026-01-15
200
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the LP-003 injection in a Phase II clinical trial for adults with moderate to severe persistent allergic asthma. This trial aims to assess the effectiveness, safety, and how the body processes LP-003 compared to placebo and an active drug called Omalizumab. The study involves multiple centers and uses a randomized, masked design to carefully compare outcomes among different treatment groups. Participants receive subcutaneous injections of LP-003 at doses of 150 mg, 300 mg, or 450 mg every 4 weeks, or Omalizumab injections at doses based on IgE levels and body weight, also every 4 weeks. A placebo group receives matching injections on the same schedule. Treatment lasts for 24 weeks, followed by an additional 24 weeks of follow-up to monitor longer-term effects. Throughout the study, participants will attend scheduled visits for lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests to measure immune markers and drug levels. Researchers will monitor asthma exacerbations, lung function changes, medication use, and any adverse events for up to about 52 weeks. Participants must be able to complete diaries and use devices to track their asthma during the study period.
CONDITIONS
Brief Title
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Body weight at least 40 kg
- Diagnosed with bronchial asthma for at least 1 year
- Diagnosed with allergic asthma as per relevant guidelines
- At least 1 asthma exacerbation in the year before screening
- Positive bronchial dilation test within 24 months before screening or at screening
- Positive skin prick test or serum specific IgE test for a relevant allergen within 12 months before randomization
- Use of medium to high dose inhaled corticosteroids for at least 8 weeks before screening, stable for 4 weeks before randomization, with partially controlled or uncontrolled asthma
- Use of at least one additional asthma control medication, stable for 4 weeks before randomization
- Forced expiratory volume in 1 second (FEV1) between 40% and 80% of predicted value at screening
- No plans for pregnancy and agreement to use effective contraception during the trial and for 6 months after last dose
- Ability to understand and fill out assessment forms, use peak expiratory flow device, record diary, and attend follow-up visits
- Voluntary signing of informed consent form
You will not qualify if you...
- Allergy to the investigational product, its excipients, or Xolair4
- Other lung diseases affecting lung function, such as COPD, allergic bronchopulmonary aspergillosis, or bronchiectasis
- Severe or uncontrolled diseases of liver, kidneys, gastrointestinal, cardiovascular, hematopoietic, urogenital, endocrine, nervous, immune systems
- Significant infection within 4 weeks before randomization
- Major surgery within 4 weeks before randomization or planned surgery during study
- Known parasitic infection within 6 months before randomization
- History of malignancy diagnosed within 5 years before screening
- Significant abnormal lab tests unsuitable for participation
- Positive tests for HIV, certain hepatitis viruses, or syphilis (with exceptions)
- Current smoking, quitting less than 6 months ago, or heavy smoking history (10+ pack-years)
- Use of biological agents or investigational biologics within 3 months or 5 half-lives prior to screening
- Use of systemic immunosuppressants or glucocorticoids for autoimmune diseases within 8 weeks or 5 half-lives prior to screening
- Allergen immunotherapy within 3 months before screening
- Live vaccines or intravenous immunoglobulin within 4 weeks before screening
- Participation in other drug trials within 3 months or 5 half-lives prior to screening
- History of drug or substance abuse or excessive alcohol use within 1 year before screening
- Pregnant or breastfeeding women
- Any condition deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive subcutaneous injections of LP-003, Omalizumab, or Placebo to manage moderate to severe persistent allergic asthma.
Injections every 4 weeks; assessments at Weeks 4, 8, 12, 16, 20, and 24
Duration - Up to approximately 28 weeks after treatment
Participants are monitored for safety and asthma control after completing treatment.
Assessments during Weeks 36 and 48
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jie Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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