Phase 4 Chronic Rhinosinusitis Trial, Completed (NCT05049122)

Phase 4 Chronic Rhinosinusitis Trial, Completed NCT05049122 Sponsor: Sanofi Condition: Chronic Rhinosinusitis

Printed from Voxsanity (voxsanity.com.au) — NCT05049122 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05049122) enrolled 25 adults who received injections of dupilumab 300 mg. The trial was measuring changes in nasal polyp size and a range of symptoms — including nasal congestion, loss of smell, and overall symptom burden — in people with chronic rhinosinusitis with nasal polyps (a condition where persistent sinus inflammation causes growths inside the nose). The main study treatment period ran for 24 weeks, with some participants continuing to 52 weeks. Of the 25 who started, 22 completed the full trial. The reported data shows that for the primary outcome — the proportion of participants whose nasal polyp score improved by at least 1 point on an 8-point scale by week 24 — the figure was 92% of participants. Regarding the secondary outcomes at week 24, the reported data shows the average nasal polyp score (on the same 0–8 scale, where higher means more severe) decreased by 2.4 points from where it started. The sinus "opacification" score — a CT scan measure of how blocked the sinuses appeared, rated 0–24 — decreased on average by 5.6 points. The overall symptom score (rated 0–9, covering congestion, smell loss, and nasal discharge) decreased by an average of 4.2 points. The nasal congestion score alone (rated 0–3) decreased by an average of 1.58 points, and the loss-of-smell score (also 0–3) decreased by an average of 1.37 points. In all cases, a decrease means movement toward fewer or less severe symptoms on those scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40884290) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You are 18 years of age or older.
You have nasal polyps in both nostrils, and despite past treatment with steroid tablets/pills at any point in the last 2 years, OR you could not take steroids for medical reasons, OR you have had surgery for nasal polyps, your polyps are still significantly present (confirmed by a nasal camera examination with a specific score).
You have had ongoing symptoms for at least 8 weeks before your first visit, including moderate to severe nasal congestion or blockage, loss of smell, and a runny nose (from the front or back of the nose).
Your body weight is more than 30 kg (approximately 66 pounds).
You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

You have certain other nasal or sinus conditions, such as a specific type of polyp called antrochoanal polyps, a severely deviated nasal septum blocking a nostril, an active sinus or upper respiratory infection, overuse of nasal decongestant sprays, or certain rare diseases affecting the airways or lungs (confirm with trial site).
You have a tumour (cancerous or non-cancerous) in the nasal cavity.
You have been diagnosed with, are suspected of having, or are considered at high risk of a parasitic infection, or you have taken anti-parasitic medication within 2 weeks before your first visit.
You have had any nasal or sinus surgery within the 6 months before your first visit.
You have previously taken part in a clinical trial involving dupilumab, or have ever been treated with dupilumab (a medication also known by the brand name Dupixent).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

GP referral letter

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Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT05049122

Sponsor: Sanofi

Phase: Phase 4

Status: Completed

Condition: Chronic Rhinosinusitis

More information: https://clinicaltrials.gov/study/NCT05049122

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are 18 years of age or older.
You have nasal polyps in both nostrils, and despite past treatment with steroid tablets/pills at any point in the last 2 years, OR you could not take steroids for medical reasons, OR you have had surgery for nasal polyps, your polyps are still significantly present (confirmed by a nasal camera examination with a specific score).
You have had ongoing symptoms for at least 8 weeks before your first visit, including moderate to severe nasal congestion or blockage, loss of smell, and a runny nose (from the front or back of the nose).
Your body weight is more than 30 kg (approximately 66 pounds).
You are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

You have certain other nasal or sinus conditions, such as a specific type of polyp called antrochoanal polyps, a severely deviated nasal septum blocking a nostril, an active sinus or upper respiratory infection, overuse of nasal decongestant sprays, or certain rare diseases affecting the airways or lungs (confirm with trial site).
You have a tumour (cancerous or non-cancerous) in the nasal cavity.
You have been diagnosed with, are suspected of having, or are considered at high risk of a parasitic infection, or you have taken anti-parasitic medication within 2 weeks before your first visit.
You have had any nasal or sinus surgery within the 6 months before your first visit.
You have previously taken part in a clinical trial involving dupilumab, or have ever been treated with dupilumab (a medication also known by the brand name Dupixent).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 4

Sponsor

Sanofi

Registry

ClinicalTrials.gov

Start date

22 October 2021

Est. completion

21 December 2022

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov