A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosin… (NCT07313917) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
China150 participantsStarted 2026-01-20
Plain-language 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 investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Participants report moderate to severe nasal congestion during the screening/run-in period and prior to randomization:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Nasal Polyps Score (NPS) at Week 24
Timeframe: Week 24
2
Change from baseline in Nasal Congestion Score (NCS) at Week 24
. 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;
Exclusion criteria
. 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;
. 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: