Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Phase 2NCT07313917
A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Phase 2 study testing LP-003 Injection in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Longbio Pharma at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- LP-003 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Sep 2027
- 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
- Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);
- Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);
- Persistence of the following symptoms for ≥ 4 weeks prior to the screening/run-in period:
- Nasal congestion;
- Any one of the other symptoms: mucoid or mucopurulent nasal discharge, head and facial distension/pain, hyposmia or anosmia;
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- Nasal Polyp Score (NPS) ≥ 5 points, with each nasal cavity scoring at least ≥ 2 points during the screening/run-in period and prior to randomization;
- Participants report moderate to severe nasal congestion during the screening/run-in period and prior to randomization:
- Nasal Congestion Score (NCS) of 2 or 3 points at the screening/run-in period (Visit 1, V1);
- Mean weekly NCS ≥ 2 points prior to randomization;
- With bilateral CRSwNP despite prior treatment with systemic corticosteroids (SCS) such as oral corticosteroids (OCS) within 2 years prior to screening; and/or has contraindications to SCS treatment or is intolerant to SCS; and/or has undergone nasal polypectomy within 6 months prior to screening, with persistent bilateral CRSwNP.
- Has been on a stable dosage of intranasal corticosteroids (INCS) for at least 4 weeks prior to screening;
- Demonstrates ≥80% adherence to mometasone furoate nasal spray (MFNS) administration during the run-in period (with a minimum of 14 days of use).
Who cannot join
- Concurrent other nasal diseases or nasal symptoms;
- Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;
- Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks;
- Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;
- Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or participants with a history of such infections that have resolved but are assessed by the investigator as likely to recur frequently;
- Any severe or unstable disease that the investigator believes may affect the participant's safety during the study and/or hinder the participant from completing the study;
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- Has any severe or unstable disease that, in the investigator's judgment, may affect the safety of the trial participant during the study and/or preclude the participant from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, autoimmune, hematological, or psychiatric disorders.
- Current or prior receipt of the following treatments:
- Use of traditional Chinese medicine (TCM) or proprietary Chinese medicines for chronic rhinosinusitis within 1 week prior to screening;
- Use of medium- or short-acting systemic corticosteroids (SCS) within 4 weeks prior to randomization, or long-acting SCS within 6 weeks prior to randomization;
- Receipt of any systemic monoclonal antibody therapy [e.g., Stapokibart, Dupilumab, Mepolizumab, Omalizumab, Tezepelumab, etc.] within 10 weeks prior to randomization or within 5 half-lives (whichever is longer);
- Use of systemic immunosuppressants within 4 weeks prior to randomization or within 5 half-lives (whichever is longer);
- Initiation of leukotriene receptor antagonist (LTRA) therapy within 4 weeks prior to randomization (participants who have been receiving stable-dose LTRA therapy for at least 4 weeks prior to randomization are eligible for enrollment);
- For participants with concurrent asthma, the forced expiratory volume in 1 second (FEV1) as a percentage of predicted value ≤ 50% during the screening/run-in period;
- Known allergy or intolerance to any component of the investigational product and/or mometasone furoate nasal spray;
- Pregnant or lactating females;
- Any other conditions that the investigator deems inappropriate for the participant to participate in the study.
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
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing
Luo Zhang, +86-010-65141136, dr.luozhang@139.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.
- Being tested
- LP-003 Injection, Placebo of LP-003
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
Placebo of LP-003Biological
s.c. injection, Q12W
| Study group | Role | What they receive |
|---|---|---|
| LP-003 300 mg group | Experimental | Participants will receive subcutaneous injection of LP-003 Injection at a dose of 300 mg once every 12 weeks. Receives: Biological: LP-003 Injection |
| LP-003 450 mg group | Experimental | Participants will receive subcutaneous injection of LP-003 Injection at a dose of 450 mg once every 12 weeks. Receives: Biological: LP-003 Injection |
| Placebo | Placebo comparator | Participants will receive subcutaneous injection of placebo Injection once every 12 weeks. Receives: Biological: Placebo of LP-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Nasal Polyps Score (NPS) at Week 24
NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Measured: Week 24
Change from baseline in Nasal Congestion Score (NCS) at Week 24
The NCS is a patient-reported outcome measure using a 0-3 point Verbal Rating Scale (VRS). Patients rate their nasal congestion severity as 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), or 3 (severe symptoms). The total score ranges from 0 to 3, with higher scores indicating more severe nasal congestion.
Measured: Week 24
Secondary outcomes (9)
Change from baseline in NPS at each assessment visit (excluding Week 24)
Measured: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NPS from baseline
Measured: Up to approximately 56 weeks
Percentage of participants with a ≥2-point improvement in NPS from baseline
Measured: Up to approximately 56 weeks
Change from baseline in NCS at each assessment visit (excluding Week 24)
Measured: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NCS from baseline
Measured: Up to approximately 56 weeks
Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22)
The SNOT-22 is a validated 22-items questionnaire to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL) with a recall period of 2 weeks. There are 5 domains that could be described within SNOT-22, including nasal, ear, sleep, general and practical, and emotional; each domain was scored on a 6-category scale which ranged from 0: no problem to 5: problem as bad as it can be. The total score was the sum of response to each of the 22 questions and ranged from 0 (no disease) to 110 (worst disease), higher scores indicated worse HRQoL.
Measured: Up to approximately 56 weeks
Incidence of adverse events (AEs)
Measured: Up to approximately 56 weeks
Number of patients with anti-drug antibodies (ADA)
Measured: Up to approximately 56 weeks
Serum concentrations of LP-003
Measured: Up to approximately 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longbio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Principal investigator, Beijing Tongren Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313917
- Sponsor's protocol ID
- P10-LP003-12
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- ClinicalTrials.gov ID
- NCT07313917
- Acronym / sponsor ID
- P10-LP003-12
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Longbio PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 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, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LP-003 300 mg group | Experimental | Biological: LP-003 InjectionParticipants will receive subcutaneous injection of LP-003 Injection at a dose of 300 mg once every 12 weeks. |
| LP-003 450 mg group | Experimental | Biological: LP-003 InjectionParticipants will receive subcutaneous injection of LP-003 Injection at a dose of 450 mg once every 12 weeks. |
| Placebo | Placebo comparator | Biological: Placebo of LP-003Participants will receive subcutaneous injection of placebo Injection once every 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Capable of understanding the study and voluntarily signing the Informed Consent Form (ICF);
- Aged 18 to 75 years (inclusive) at the time of signing the ICF, regardless of gender;
- Diagnosis of bilateral chronic rhinosinusitis with nasal polyps (CRSwNP);
- Persistence of the following symptoms for ≥ 4 weeks prior to the screening/run-in period:
- Nasal Polyp Score (NPS) ≥ 5 points, with each nasal cavity scoring at least ≥ 2 points during the screening/run-in period and prior to randomization;
Key exclusion criteria (17 listed)
- Concurrent other nasal diseases or nasal symptoms;
- Acute upper respiratory tract infection at screening, which the investigator assesses may affect nasal symptom scoring;
- Severe infection requiring intravenous antibiotics and/or hospitalization within 4 weeks prior to randomization that has not yet resolved, or active infection requiring oral antibiotics within 2 weeks prior to randomization that has not yet resolved; the investigator assesses that enrollment of the participant may pose uncontrollable risks;
- Concurrent active parasitic infection (e.g., helminths) or suspected parasitic infection;
- Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis); or participants with a history of such infections that have resolved but are assessed by the investigator as likely to recur frequently;
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-003 300 mg group, LP-003 450 mg group |
| Placebo of LP-003s.c. injection, Q12W | Biological | Placebo |
Primary outcome
Change from baseline in Nasal Polyps Score (NPS) at Week 24
Time frame: Week 24
NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Change from baseline in Nasal Congestion Score (NCS) at Week 24
Time frame: Week 24
The NCS is a patient-reported outcome measure using a 0-3 point Verbal Rating Scale (VRS). Patients rate their nasal congestion severity as 0 (no symptoms), 1 (mild symptoms), 2 (moderate symptoms), or 3 (severe symptoms). The total score ranges from 0 to 3, with higher scores indicating more severe nasal congestion.
9 secondary outcomes
Change from baseline in NPS at each assessment visit (excluding Week 24)
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NPS from baseline
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥2-point improvement in NPS from baseline
Time frame: Up to approximately 56 weeks
Change from baseline in NCS at each assessment visit (excluding Week 24)
Time frame: Up to approximately 56 weeks
Percentage of participants with a ≥1-point improvement in NCS from baseline
Time frame: Up to approximately 56 weeks
Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22)
Time frame: Up to approximately 56 weeks
Incidence of adverse events (AEs)
Time frame: Up to approximately 56 weeks
Number of patients with anti-drug antibodies (ADA)
Time frame: Up to approximately 56 weeks
Serum concentrations of LP-003
Time frame: Up to approximately 56 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 6 Feb 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.
Luo Zhang principal investigator
Beijing Tongren Hospital Affiliated to Capital Medical University
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 in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), 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 13 inclusion and 17 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: opening soon, as of the sponsor's last update on 6 Feb 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?
Change from baseline in Nasal Polyps Score (NPS) at Week 24 (time frame: Week 24). The study lists 2 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 6 Feb 2026.