A Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab, in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) on a Background Therapy With Intranasal Corticosteroids
Overview
- Phase
- Phase 3
- Intervention
- Dupilumab
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Sponsor
- Sanofi
- Enrollment
- 63
- Locations
- 18
- Primary Endpoint
- Change From Baseline in Nasal Polyps Score at Week 24
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray).
Study details include:
- The study duration will be up to 40 weeks.
- The treatment duration will be up to 24 weeks.
- The number of visits will be 7.
Detailed Description
up to 40 weeks
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be at least 18 years of age at the time of signing the informed consent
- •Participants with bilateral sino-nasal polyposis that despite prior treatment with SCS anytime within the past 2 years; and/or who have a medical contraindication/intolerance to SCS; and/or had prior surgery for NP at Visit 1 have:
- •An endoscopic bilateral NPS at Visit 1 of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) as per central assessment
- •Ongoing symptoms (for at least 8 weeks before Visit 1) of:
- •Nasal congestion/blockade/obstruction with moderate or severe symptom severity (Score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 at time of randomization (Visit 2) AND
- •Another symptom such as loss of smell, rhinorrhea (anterior/posterior)
- •Note: Plan to enroll at least 85% (approximately 52) participants with CRSwNP meeting following criterion:
- •Participants with peripheral blood eosinophil count ≥300/mm3
- •Contraceptive use should be consistent with the regulations regarding the methods of contraception for those participating in clinical studies
- •Capable of giving signed informed consent
Exclusion Criteria
- •Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint (ie, NPS)
- •Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, hemangioma, etc)
- •Participant with historical spirometry results which showed 50% or less of predicted normal of forced expiratory volume in one second (FEV1)
- •Diagnosed with; suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before Visit 1 or during the screening period
- •History of human immunodeficiency virus infection or positive HIV 1/2 serology at Visit 1
- •Known or suspected immunodeficiency
- •Participants with active Tuberculosis (TB), non-tuberculous mycobacterial infection or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before Visit 1 or during the screening period
- •Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
- •Known or suspected alcohol and/or drug abuse
Arms & Interventions
Dupilumab
Dupilumab every 2 weeks (Q2W) via SC injection
Intervention: Dupilumab
Dupilumab
Dupilumab every 2 weeks (Q2W) via SC injection
Intervention: Budesonide
Placebo
Placebo matching dupilumab Q2W via SC injection
Intervention: Placebo
Placebo
Placebo matching dupilumab Q2W via SC injection
Intervention: Budesonide
Outcomes
Primary Outcomes
Change From Baseline in Nasal Polyps Score at Week 24
Time Frame: Baseline (Day 1) and Week 24
The NPS was the sum of the right and left nostril scores and assessed by central video recordings of bilateral nasal endoscopy. For each nostril, NPS was graded based on polyp size which ranged from 0: no polyps, 1: small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2: polyps reaching below the lower border of the middle turbinate, 3: large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, 4: large polyps causing complete obstruction of the inferior nasal cavity. Total NPS was the sum of right and left nostril scores; ranged from 0 (no polyps) to 8 (large polyps). Higher scores indicated more severe disease. Baseline was defined as the last available value before randomization.
Secondary Outcomes
- Change From Baseline in Nasal Congestion/Obstruction Score (NCS) at Week 24(Baseline (Day -7 to Day -1) and Week 24)
- Change From Baseline in Total Symptoms Score (TSS) at Week 24(Baseline (Day -7 to Day -1) and Week 24)
- Change From Baseline in Total Score of 22-Items Sinonasal Outcome Test (SNOT-22) at Week 24(Baseline (Day 1) and Week 24)
- Percentage of Participants Who Received Systemic Corticosteroid (SCS) or Underwent Nasal Polyposis (NP) Surgery During the Study Treatment(From randomization (Day 1) up to last dose of study treatment + 14 days, a maximum of 168 days)
- Change From Baseline in the Severity of Decreased/Loss of Smell at Week 24(Baseline (Day -7 to Day -1) and Week 24)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent Adverse Events Leading to Treatment Discontinuation(From first dose of study treatment (Day 1) up to last dose of study treatment + 98 days, a maximum of 252 days)