Clinical trial NCT05049122: Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* 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 V1.
* Signed written informed consent.

Exclusion Criteria:

* 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 V1.
* 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.

Primary outcomes:
measure: Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24
timeFrame: Baseline (Day 1) and Week 24
Secondary outcomes:
measure: Change From Baseline in Bilateral NPS at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Nasal Congestion/Obstruction (NC) Symptom Severity Score Using the CRSwNP Nasal Symptom Diary at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Opacification of Sinuses Assessed by Computerized Tomography (CT) Scan Using the Lund Mackay (LMK) Score at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Total Symptom Score (TSS) at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Loss of Smell Symptom Severity Score Using the Nasal Symptom Diary at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis at Week 24
timeFrame: Baseline (Day 1) and Week 24
measure: 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
timeFrame: From Baseline (Day 1) up to Week 24
Other outcomes:
Locations:
city: Japan
country: Japan
facility: Investigational site JAPAN
Study officials:
References: