Allergic AsthmaPhase 2NCT07342803
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
A Phase 2 study testing LP-003 Injection and Omalizumab in people with Allergic Asthma, run by Longbio Pharma at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- LP-003 Injection and Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2025to 30 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Subjects 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;
- Subjects 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 propionate 2000 μg/day or equivalent dose of ICS, as per the "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)"), have maintained stable use for 4 weeks before randomization, with asthma remaining partially controlled or uncontrolled (defined as ACT score ≤ 19);
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- 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 treatment) and stable use for 4 weeks before randomization ;
- At screening, 40% < FEV1 < 80% of predicted value;
- Subjects 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;
- Subjects 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 female, aged 18 to 75 years.
Who cannot join
- 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;
- 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;
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- 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 below the detection limit of the site), or positive for hepatitis B core antibody (except HBV-DNA below the detection limit of the site), or positive for hepatitis C virus (HCV) antibodies (except HCV RNA below the detection limit of the site);
- 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 cigarettes];
- 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 lupus erythematosus, etc.) within 8 weeks prior to screening or within 5 half-lives of the drug (whichever is longer);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai
Wei Tang, +86 189170 0579, tina_tangwei@163.com
About this study
Official title: 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.
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
- Allergic Asthma
- Being tested
- LP-003 Injection, Omalizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-003 InjectionBiological
s.c. injection, Q12W
OmalizumabBiological
s.c. injection, Q4W
PlaceboBiological
s.c. injection, Q4W
| Study group | Role | What they receive |
|---|---|---|
| LP-003 150 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. Receives: Biological: LP-003 Injection; Biological: Placebo |
| LP-003 300 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. Receives: Biological: LP-003 Injection; Biological: Placebo |
| LP-003 450 mg group | Experimental | Participants received subcutaneous injections of LP-003 or Placebo every 4 weeks. Receives: Biological: LP-003 Injection; Biological: Placebo |
| Omalizumab group | Active comparator | Participants received subcutaneous injection of Omalizumab every 4 weeks; the dose was determined by baseline IgE level and body weight, with a maximum dose 600 mg. Receives: Biological: Omalizumab |
| Placebo group | Placebo comparator | Participants received subcutaneous injection of Placebo every 4 weeks. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of asthma exacerbations per subject
Measured: During the 24-week treatment period
Proportion of subjects with asthma exacerbations
Measured: During the 24-week treatment period
Mean number of asthma exacerbations per subject
Measured: During the 36-week and 48-week follow-up period
Proportion of subjects with asthma exacerbations
Measured: During the 36-week and 48-week follow-up period
Proportion of subjects with loss of asthma control (LOAC) in each group
Measured: During the 24-week treatment period
Incidence of adverse events (AEs)
Measured: Up to approximately 52 weeks
Change from baseline in pre-bronchodilator FEV1, FVC, and FEV1/FVC ratio
Measured: Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in weekly mean daily and weekly Peak Expiratory Flow (PEF) variability, and change from baseline in mean PEF
Measured: Weeks 4, 8, 12, 16, 20, and 24
Time to first asthma exacerbation from baseline
Measured: Up to approximately 52 weeks
Change from baseline in weekly use of reliever medication (Salbutamol Sulfate Aerosol)
Measured: Up to approximately 52 weeks
Change from baseline in weekly Asthma Symptom Diary Score
Measured: Up to approximately 52 weeks
Change from baseline in standardized Asthma Quality of Life Questionnaire (AQLQ(S))
The AQLQ(S) is a validated patient-reported outcome (PRO) tool designed to assess the impact of asthma on patients' quality of life. This questionnaire consists of a total of 35 items, which are scored on a 7-point Likert scale (where 1 indicates the worst quality of life and 7 indicates the best quality of life).
Measured: Weeks 12 and 24
Change from baseline in Asthma Control Questionnaire (ACQ-5)
The ACQ-5 is a tool for evaluating asthma control status. The questionnaire comprises 5 items, with the ACQ-5 score calculated as the mean score of the 5 items. A score of < 0.75 indicates complete asthma control, a score between 0.75 and 1.5 indicates well-controlled asthma, and a score of > 1.5 indicates uncontrolled asthma.
Measured: Weeks 12 and 24
Change from baseline in Asthma Control Test (ACT)
The ACT is a tool for assessing asthma control status, comprising 5 questions with 5 response options each (scored 1 to 5 points per question). The total score is the sum of the 5 items, with the following criteria: 20-25 = well-controlled; 16-19 = inadequately controlled; 5-15 = very poorly controlled.
Measured: Weeks 12 and 24
Change in serum free IgE levels over time at different time points
Measured: Up to approximately 52 weeks
Serum concentrations of LP-003 at different time points
Measured: Up to approximately 52 weeks
Incidence of Anti-drug Antibodies (ADA)
Measured: Up to approximately 52 weeks
Secondary outcomes (3)
Change from baseline in Fractional exhaled Nitric Oxide (FeNO)
Measured: Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in blood eosinophil count (EOS)
Measured: Weeks 4, 8, 12, 16, 20, and 24
Change in serum total IgE levels over time at different time points
Measured: Up to approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start25 Jan 2025
- Primary completion28 Dec 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieming Qu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342803
- Sponsor's protocol ID
- P10-LP003-05
- Status last verified
- Oct 2025
- First submitted
- 11 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07342803
- Acronym / sponsor ID
- P10-LP003-05
- Conditions
- Allergic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LP-003 150 mg group | Experimental | Biological: LP-003 Injection, Biological: PlaceboParticipants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
| LP-003 300 mg group | Experimental | Biological: LP-003 Injection, Biological: PlaceboParticipants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
| LP-003 450 mg group | Experimental | Biological: LP-003 Injection, Biological: PlaceboParticipants received subcutaneous injections of LP-003 or Placebo every 4 weeks. |
| Omalizumab group | Active comparator | Biological: OmalizumabParticipants received subcutaneous injection of Omalizumab every 4 weeks; the dose was determined by baseline IgE level and body weight, with a maximum dose 600 mg. |
| Placebo group | Placebo comparator | Biological: PlaceboParticipants received subcutaneous injection of Placebo every 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
- Subjects 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;
Key exclusion criteria (18 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-003 Injections.c. injection, Q12W | Biological | LP-003 150 mg group, LP-003 300 mg group, LP-003 450 mg group |
| Omalizumabs.c. injection, Q4W | Biological | Omalizumab group |
| Placebos.c. injection, Q4W | Biological | LP-003 150 mg group, LP-003 300 mg group, LP-003 450 mg group, Placebo group |
Primary outcome
Mean number of asthma exacerbations per subject
Time frame: During the 24-week treatment period
Proportion of subjects with asthma exacerbations
Time frame: During the 24-week treatment period
Mean number of asthma exacerbations per subject
Time frame: During the 36-week and 48-week follow-up period
Proportion of subjects with asthma exacerbations
Time frame: During the 36-week and 48-week follow-up period
Proportion of subjects with loss of asthma control (LOAC) in each group
Time frame: During the 24-week treatment period
Incidence of adverse events (AEs)
Time frame: Up to approximately 52 weeks
Change from baseline in pre-bronchodilator FEV1, FVC, and FEV1/FVC ratio
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in weekly mean daily and weekly Peak Expiratory Flow (PEF) variability, and change from baseline in mean PEF
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Time to first asthma exacerbation from baseline
Time frame: Up to approximately 52 weeks
Change from baseline in weekly use of reliever medication (Salbutamol Sulfate Aerosol)
Time frame: Up to approximately 52 weeks
Change from baseline in weekly Asthma Symptom Diary Score
Time frame: Up to approximately 52 weeks
Change from baseline in standardized Asthma Quality of Life Questionnaire (AQLQ(S))
Time frame: Weeks 12 and 24
The AQLQ(S) is a validated patient-reported outcome (PRO) tool designed to assess the impact of asthma on patients' quality of life. This questionnaire consists of a total of 35 items, which are scored on a 7-point Likert scale (where 1 indicates the worst quality of life and 7 indicates the best quality of life).
Change from baseline in Asthma Control Questionnaire (ACQ-5)
Time frame: Weeks 12 and 24
The ACQ-5 is a tool for evaluating asthma control status. The questionnaire comprises 5 items, with the ACQ-5 score calculated as the mean score of the 5 items. A score of < 0.75 indicates complete asthma control, a score between 0.75 and 1.5 indicates well-controlled asthma, and a score of > 1.5 indicates uncontrolled asthma.
Change from baseline in Asthma Control Test (ACT)
Time frame: Weeks 12 and 24
The ACT is a tool for assessing asthma control status, comprising 5 questions with 5 response options each (scored 1 to 5 points per question). The total score is the sum of the 5 items, with the following criteria: 20-25 = well-controlled; 16-19 = inadequately controlled; 5-15 = very poorly controlled.
Change in serum free IgE levels over time at different time points
Time frame: Up to approximately 52 weeks
Serum concentrations of LP-003 at different time points
Time frame: Up to approximately 52 weeks
Incidence of Anti-drug Antibodies (ADA)
Time frame: Up to approximately 52 weeks
3 secondary outcomes
Change from baseline in Fractional exhaled Nitric Oxide (FeNO)
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change from baseline in blood eosinophil count (EOS)
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Change in serum total IgE levels over time at different time points
Time frame: Up to approximately 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jieming Qu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP-003 Injection and Omalizumab in people with Allergic Asthma, run by Longbio Pharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Yang (+86 021-58372390, yangj@longbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of asthma exacerbations per subject (time frame: During the 24-week treatment period). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.