A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study Evaluating the Efficacy and Safety of AK139 in Participants With Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Nasal Polyp Score (NPS)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving background treatment with mometasone furoate nasal spray (MFNS).
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 in participants with chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligible participants will be randomized to receive AK139 or placebo in addition to background treatment with mometasone furoate nasal spray (MFNS). The study will assess the effect of AK139 on nasal polyp burden, disease symptoms, health-related quality of life, safety, PK, PD, and immunogenicity throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
- •Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), contraindications to or intolerance of SCS, and/or prior nasal polyp surgery.
- •Nasal Polyp Score (NPS) ≥5, with a minimum score of 2 in each nasal cavity, at screening and baseline.
- •Ongoing nasal congestion/obstruction, with a Nasal Congestion Score (NCS) of 2 or 3 at screening and baseline.
- •Use of intranasal corticosteroids for at least 4 weeks prior to screening.
排除标准
- •History of sinonasal surgery (including nasal polypectomy) within 6 months prior to screening, or prior nasal surgery resulting in structural changes that preclude adequate assessment of Nasal Polyp Score (NPS).
- •Presence of any of the following conditions:
- •Antrochoanal polyp;
- •Persistent rhinitis medicamentosa;
- •Allergic fungal rhinosinusitis with symptoms and/or CT findings.
- •Nasal malignant or benign tumors.
- •Severe nasal septal deviation causing obstruction of at least one nostril.
- •Known eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, or other systemic diseases associated with nasal polyposis.
- •Participants with asthma and FEV1 ≤50% of the predicted value at screening or baseline.
- •Parasitic infection, active tuberculosis, recurrent or chronic infectious diseases, or autoimmune diseases.
- •Acute sinusitis, nasal infection, or upper respiratory tract infection within 2 weeks prior to screening or during the screening period.
- •Chronic infection with hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or syphilis.
- •Treatment with anti-IL-4Rα monoclonal antibodies, anti-thymic stromal lymphopoietin (TSLP) monoclonal antibodies, anti-immunoglobulin E (IgE) monoclonal antibodies, or other biologic agents within 10 weeks or 5 half-lives (whichever is longer) before randomization, or prior treatment with AK
- •Treatment with short- or intermediate-acting systemic corticosteroids within 4 weeks prior to screening, or long-acting systemic corticosteroids within 6 weeks prior to screening.
- •Prior treatment with anti-IL-4Rα monoclonal antibodies with inadequate clinical response.
研究组 & 干预措施
AK139 regimen 1
AK139 regimen 1 will be administered by subcutaneous injection
干预措施: AK139 (Biological)
Placebo
Placebo will be administered by subcutaneous injection.
干预措施: Placebo (Biological)
AK139 regime 2
AK139 regime 2 will be administered by subcutaneous injection.
干预措施: AK139 (Biological)
结局指标
主要结局
Nasal Polyp Score (NPS)
时间窗: Baseline and Week 16
Change from baseline in Nasal Polyp Score (NPS). 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.
Nasal Congestion Score (NCS)
时间窗: Baseline and Week 16
Change from baseline in Nasal Congestion Score (NCS). NCS is a patient-reported outcome measure using a 4-point Verbal Rating Scale (VRS) ranging from 0 to 3. Higher scores indicate more severe nasal congestion.
次要结局
- Nasal Polyp Score (NPS)(From baseline to Week 20 (excluding Week 16))
- Nasal Congestion Score (NCS)(From baseline through Week 20 (excluding Week 16))
- Total Symptom Score (TSS)(From baseline to Week 20)
- Sino-Nasal Outcome Test-22 (SNOT-22)(From baseline to Week 20)
- Lund-Mackay Score(Baseline and Week 16)
- Safety parameters(Up to Week 20)
- Pharmacokinetics (PK)(Up to Week 20)
- Pharmacodynamics (PD)(From baseline to Week 20)
- Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb)(Up to Week 20)