A Single-arm, 52 Weeks, Phase 4 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Who Are Not Adequately Controlled With Existing Therapies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24
研究概览
简要总结
This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies.
Duration of study period (per participant):
- Screening Period (2 to 4 weeks)
- Intervention Period (up to 52 weeks±3 days)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≧18 years of age.
- •Participants with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or had a medical contraindication / intolerance to SCS; and/or had prior surgery for NP at the screening visit, had:
- •An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
- •Ongoing symptoms (for at least 8 weeks prior to Visit [V] 1) of nasal congestion/blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at the time of enrollment (V2), and loss of smell, rhinorrhea (anterior/posterior).
- •Participant's body weight > 30 kg at V
- •Signed written informed consent.
排除标准
- •Participant with conditions/concomitant diseases making them non evaluable at V1 or for the primary efficacy endpoint such as: Antrochoanal polyps; Nasal septal deviation that would occlude at least one nostril; Acute sinusitis, nasal infection or upper respiratory infection; Ongoing rhinitis medicamentosa; Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis; Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis;
- •Participant with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil, etc).
- •Participant diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before V1 or during screening
- •Undergone any and/or sinus intranasal surgery within 6 months before V
- •Participant who had participated in prior dupilumab clinical study or had been treated with commercially available dupilumab
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dupilumab
Dupilumab every 2 weeks (q2w). Dosing interval may be changed from q2w to q4w at week 24
干预措施: Dupilumab SAR231893 (Drug)
结局指标
主要结局
Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24
时间窗: Baseline (Day 1) and Week 24
The NPS was the sum of right and left nostril scores as assessed by central video recordings of nasal endoscopy (NE). For each nostril, NPS was graded based on polyp size: Grade 0:No polyps; Grade 1:Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; Grade 2:Polyps reaching below the lower border of the middle turbinate; Grade 3:Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; Grade 4:Large polyps causing complete obstruction of the inferior nasal cavity. Score ranged from 0-8; higher scores indicated more severity. The baseline value was defined as the last available value before first study treatment administration.
次要结局
- Change From Baseline in Bilateral NPS at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Nasal Congestion/Obstruction (NC) Symptom Severity Score Using the CRSwNP Nasal Symptom Diary at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Opacification of Sinuses Assessed by Computerized Tomography (CT) Scan Using the Lund Mackay (LMK) Score at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Total Symptom Score (TSS) at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Loss of Smell Symptom Severity Score Using the Nasal Symptom Diary at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis at Week 24(Baseline (Day 1) and Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation at the End of 24-Week Treatment Period(From Baseline (Day 1) up to Week 24)