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 (NCT02898454) enrolled 448 adults across three groups: 153 received a placebo (an inactive treatment), 145 received dupilumab 300 mg every two weeks and then switched to every four weeks, and 150 received dupilumab 300 mg every two weeks throughout. The trial was measuring changes over 24 weeks in nasal polyp size and nasal congestion severity, along with several other symptoms including sense of smell, sinus blockage, and overall symptom burden. For the 24-week results, the two dupilumab groups were combined into one pooled group for comparison against placebo. The reported data shows the following changes from the starting point to week 24 (where a more negative number means a greater reduction on that scale). For nasal congestion — rated 0 to 3, with 3 being most severe — the placebo group's average score changed by −0.38, while the dupilumab group's changed by −1.25. For nasal polyp size — rated 0 to 8, with 8 being largest — the placebo group's score changed by +0.10 (a slight increase), while the dupilumab group's changed by −1.71. For sinus opacification (how blocked the sinuses appeared on imaging, scored 0 to 24), the placebo group changed by −0.09 and the dupilumab group by −5.21. For the combined symptom score (0 to 9 scale), the placebo group changed by −1.00 and the dupilumab group by −3.45. The reported data also shows results for sense of smell. On a standardised smell identification test scored 0 to 40 — where a higher score means a better sense of smell — the placebo group's average changed by −0.81 (a slight worsening) and the dupilumab group's changed by +9.71 (an increase). On the participant-reported smell loss scale (0 to 3), the placebo group changed by −0.23 and the dupilumab group by −1.21. 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 39343385) ↗
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.
Phase 3 Chronic Rhinosinusitis Trial, Completed
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 have nasal polyps in both nostrils, and despite previous treatment with steroid tablets/pills at any point in the last 2 years, your polyps are still present — or you were unable to take steroid pills due to a medical reason, or you have had surgery for nasal polyps in the past.
- At your first visit, a doctor looking inside your nose with a camera found that your polyps scored at least 5 out of 8 (with at least 2 out of 4 in each nostril).
- You have had significant nasal congestion, blockage, or obstruction for at least 8 weeks before your first visit, rated as moderate or severe, plus at least one other symptom such as loss of smell or a runny nose (from the front or back of the nose).
- You are willing and able to sign a consent form agreeing to take part in the study.
Who may not be able to join:
- You are under 18 years of age.
- You have previously taken part in a clinical trial involving the drug dupilumab.
- You have taken certain medicines that affect the immune system (such as biologic therapies or immunosuppressants used for conditions like rheumatoid arthritis or lupus) within roughly the last 2 months or longer, depending on the specific drug.
- You have taken any experimental antibody-type medication within 6 months before your first visit (or within a specific timeframe depending on the drug).
- You have taken the anti-allergy medication omalizumab (Xolair) within 130 days before your first visit.
- You have started taking leukotriene-blocking medications (a type of allergy/asthma medicine) less than 30 days before your first visit.
- You started allergy shots or immunotherapy within 3 months before your first visit, or plan to start or change the dose during the trial.
- You have had any nasal or sinus surgery (including removal of polyps) within 6 months before your first visit.
- You have had nasal or sinus surgery that significantly changed the structure inside your nose, making it impossible to properly assess your polyps.
- You have certain other nasal or sinus conditions that would make it difficult to evaluate the trial's main outcome, such as a specific type of large polyp (antrochoanal), a severely deviated nasal septum blocking at least one nostril, an active sinus or upper respiratory infection, overuse of nasal decongestant sprays, certain rare inflammatory or structural conditions of the nose and airways, cystic fibrosis, or a suspected or confirmed fungal sinus infection (confirm with trial site).
- You have a cancerous or certain non-cancerous tumour in your nasal cavity (confirm with trial site).
- Your lung function (ability to breathe out forcefully) is 50% or less of what would be expected for a healthy person your age.
- You are currently taking any medication that is not allowed in this study (confirm with trial site).
- You have received a live vaccine within 4 weeks before the start of the main treatment phase — or within 12 weeks before the start of the main treatment phase (confirm with trial site, as both timeframes are listed).
- You have HIV, or tested positive for HIV during screening.
- You tested positive for hepatitis B or hepatitis C during screening.
- You have an active infection (short-term or long-term) that requires medicine taken by mouth or injection, within 2 weeks before the start of treatment.
- You have a known or suspected history of a weakened immune system.
- You are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
- You are a woman of childbearing age who is sexually active but unwilling to use an adequate form of contraception during the study.
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.
Contact this trial
Principal Investigator: Clinical Sciences & Operations, Sanofi
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score; Change From Baseline at Week 24 in Nasal Polyp Score
Can't join this trial?
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.