Phase 4
N=25
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)
Chronic Rhinosinusitis With Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT05049122 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Jan 2024
Primary outcome: Primary: Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24 — 92.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dupilumab SAR231893 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24 |
92.0 | — |
| SECONDARY Change From Baseline in Bilateral NPS at Week 24 |
-2.4 | — |
| SECONDARY Change From Baseline in Nasal Congestion/Obstruction (NC) Symptom Severity Score Using the CRSwNP Nasal Symptom Diary at Week 24 |
-1.58 | — |
| SECONDARY Change From Baseline in Opacification of Sinuses Assessed by Computerized Tomography (CT) Scan Using the Lund Mackay (LMK) Score at Week 24 |
-5.6 | — |
| SECONDARY Change From Baseline in Total Symptom Score (TSS) at Week 24 |
-4.20 | — |
| SECONDARY Change From Baseline in Loss of Smell Symptom Severity Score Using the Nasal Symptom Diary at Week 24 |
-1.37 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis at Week 24 |
-5.41 | — |
| SECONDARY 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 |
11; 1; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05049122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.