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 range18 Years – 75 Years
SexALL
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:
✓. 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;
✕
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
. 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: