A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Официальное название

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)

Обзор

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.

Вмешательства

• Биопрепарат LP-003 Injection
  s.c. injection, Q12W
• Биопрепарат Placebo of LP-003
  s.c. injection, Q12W

Первичные конечные точки

• Change from baseline in Nasal Polyps Score (NPS) at Week 24 [Срок оценки: Week 24]
• Change from baseline in Nasal Congestion Score (NCS) at Week 24 [Срок оценки: Week 24]

Вторичные конечные точки (9)

• Change from baseline in NPS at each assessment visit (excluding Week 24) [Срок оценки: Up to approximately 56 weeks]
• Percentage of participants with a ≥1-point improvement in NPS from baseline [Срок оценки: Up to approximately 56 weeks]
• Percentage of participants with a ≥2-point improvement in NPS from baseline [Срок оценки: Up to approximately 56 weeks]
• Change from baseline in NCS at each assessment visit (excluding Week 24) [Срок оценки: Up to approximately 56 weeks]
• Percentage of participants with a ≥1-point improvement in NCS from baseline [Срок оценки: Up to approximately 56 weeks]
• Change from baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) [Срок оценки: Up to approximately 56 weeks]
• Incidence of adverse events (AEs) [Срок оценки: Up to approximately 56 weeks]
• Number of patients with anti-drug antibodies (ADA) [Срок оценки: Up to approximately 56 weeks]
• Serum concentrations of LP-003 [Срок оценки: Up to approximately 56 weeks]

Критерии участия

Критерии включения

• 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;
• 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).

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tongren Hospital Affiliated to Capital Medical University — Пекин

Идентификаторы

NCT: NCT07313917 · P10-LP003-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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