Actively Recruiting
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Led by Longbio Pharma · Updated on 2026-01-15
200
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with no gender restriction
- Body weight at least 40 kg
- Diagnosed with bronchial asthma for at least 1 year and allergic asthma per guidelines
- At least one asthma exacerbation in the year prior to screening
- Positive bronchial dilation test within 24 months prior to screening or at screening
- Positive skin prick test or serum specific IgE for relevant allergen within 12 months prior to randomization
- Received medium to high dose inhaled corticosteroids for at least 8 weeks prior to screening and stable use for 4 weeks before randomization with partially controlled or uncontrolled asthma
- Use of at least one other asthma control medication and stable use for 4 weeks before randomization
- FEV1 between 40% and 80% of predicted value at screening
- No plans for pregnancy and agreement to use effective contraceptive measures during trial and for 6 months after last dose
- Ability to understand and complete assessments, use PEF device, record diary, and attend follow-up visits
You will not qualify if you...
- Allergy to investigational product or Xolair�
- Other lung diseases affecting lung function such as COPD, ABPA, bronchiectasis that may risk participant or affect study results
- Severe or uncontrolled diseases of liver, kidneys, gastrointestinal, cardiovascular, hematopoietic, urogenital, endocrine, nervous, or immune systems
- Significant infection within 4 weeks prior to randomization
- Major surgery within 4 weeks prior to randomization or planned surgery during study
- Known parasitic infection within 6 months prior to randomization
- History of malignancy within 5 years prior to screening
- Clinically significant abnormal lab tests deemed unsuitable by investigator
- Positive HIV, treponema pallidum (except negative RPR/TRUST), hepatitis B or C markers except with viral DNA/RNA below detection
- Current smokers, quit smoking less than 6 months ago, or history of smoking of 10 or more pack-years
- Use of biological agents or monoclonal antibodies within 3 months prior to screening or within 5 half-lives of drug
- Use of systemic immunosuppressants or glucocorticoids for inflammatory/autoimmune diseases within 8 weeks prior to screening or within 5 half-lives
- Allergen immunotherapy within 3 months prior to screening
- Live virus/bacterial vaccines or intravenous immunoglobulin within 4 weeks prior to 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 prior to screening
- Pregnant or breastfeeding women
- Any other condition making participation unsuitable as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jie Yang
CONTACT
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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