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)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Longbio Pharma
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from baseline in Nasal Polyps Score (NPS) at Week 24
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 congestion;
- •Any one of the other symptoms: mucoid or mucopurulent nasal discharge, head and facial distension/pain, hyposmia or anosmia;
- •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;
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:
- •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;
Arms & Interventions
LP-003 450 mg group
Participants will receive subcutaneous injection of LP-003 Injection at a dose of 450 mg once every 12 weeks.
Intervention: LP-003 Injection (Biological)
Placebo
Participants will receive subcutaneous injection of placebo Injection once every 12 weeks.
Intervention: Placebo of LP-003 (Biological)
LP-003 300 mg group
Participants will receive subcutaneous injection of LP-003 Injection at a dose of 300 mg once every 12 weeks.
Intervention: LP-003 Injection (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of participants with a ≥2-point improvement in NPS from baseline(Up to approximately 56 weeks)
- Change from baseline in NPS at each assessment visit (excluding Week 24)(Up to approximately 56 weeks)
- Change from baseline in NCS at each assessment visit (excluding Week 24)(Up to approximately 56 weeks)
- Percentage of participants with a ≥1-point improvement in NPS from baseline(Up to approximately 56 weeks)
- Incidence of adverse events (AEs)(Up to approximately 56 weeks)
- Percentage of participants with a ≥1-point improvement in NCS from baseline(Up to approximately 56 weeks)
- Number of patients with anti-drug antibodies (ADA)(Up to approximately 56 weeks)
- Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22)(Up to approximately 56 weeks)
- Serum concentrations of LP-003(Up to approximately 56 weeks)