Phase 3 Chronic Rhinosinusitis Trial, Completed NCT02912468 Sponsor: Sanofi Condition: Chronic Rhinosinusitis
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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 (NCT02912468) enrolled 276 adults in total — 133 in the placebo group and 143 in the dupilumab 300 mg group. The trial was measuring changes over 24 weeks in people with nasal polyps, looking mainly at two things: how blocked participants felt their nose was (rated on a 0–3 scale, where higher means more severe), and the actual size of the nasal polyps as seen on a camera examination (rated on a 0–8 scale, where higher means larger polyps). A number of secondary measurements were also taken, including sinus cloudiness on scans, overall nasal symptoms, and sense of smell. The reported data shows that for nasal congestion, scores dropped by an average of 0.45 points in the placebo group and 1.34 points in the dupilumab group from where they started. For nasal polyp size, the placebo group's average score actually went up slightly by 0.17 points, while the dupilumab group's average score went down by 1.89 points. Regarding sinus cloudiness (measured on a 0–24 scale), the placebo group saw a decrease of 0.74 points and the dupilumab group saw a decrease of 8.18 points. For the overall symptom score (0–9 scale), the reported changes were −1.17 for placebo and −3.77 for dupilumab. On a 40-point smell identification test (where a higher score means a better sense of smell), scores rose by an average of 0.70 points in the placebo group and 11.26 points in the dupilumab group. The self-reported loss-of-smell score (0–3 scale) decreased by 0.29 points in the placebo group and 1.41 points in the dupilumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT02912468
Completed Phase 3

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 that have not been controlled well enough, even after trying steroid tablets/pills at some point in the last 2 years, or you were unable to take steroids due to a medical reason or side effects, or you have previously had surgery to treat your nasal polyps.
  • A doctor's examination of your nasal passages shows that your polyps are rated at least 5 out of 8 in severity (with at least a score of 2 in each nostril).
  • You have had ongoing nasal blockage or congestion 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.
  • You are willing and able to sign a consent form agreeing to take part in the trial.

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 immune-suppressing or biologic medications (used for conditions like rheumatoid arthritis or lupus) within roughly the last 2 months or longer (confirm with trial site).
  • You have received any experimental antibody treatment within the last 6 months (or longer, depending on the medication).
  • You have taken the allergy medication omalizumab (Xolair) within the last 130 days.
  • You recently started taking leukotriene modifier medications (a type of allergy/asthma medicine) less than 30 days before your first visit.
  • You started allergy immunotherapy (allergy shots or similar) within 3 months before your first visit, or plan to start or change the dose during the study.
  • You have had nasal or sinus surgery (including polyp removal) within the last 6 months.
  • You have had a type of sinus surgery that permanently changed the inner structure of your nose in a way that makes it impossible to properly measure your polyps.
  • You have certain other nasal or sinus conditions that would make it hard to assess the trial's results, such as a specific type of polyp called antrochoanal polyps, a severely deviated nasal septum blocking a nostril, a current sinus or upper respiratory infection, overuse of nasal decongestant sprays, certain rare conditions affecting the airways (such as Churg-Strauss syndrome, Wegener's granulomatosis, cystic fibrosis, or others), or a suspected or confirmed fungal sinus infection (confirm with trial site).
  • You have any cancerous or certain non-cancerous tumours in your nasal cavity.
  • Your lung function test result (a breathing test called FEV1) shows your lungs are working at 50% or less of what is expected for someone of your age and size.
  • You are receiving other treatments that are not permitted in this study (confirm with trial site).
  • You have received a live vaccine within 12 weeks before the start of the study.
  • You have HIV, hepatitis B, or hepatitis C.
  • You have an active infection that currently requires treatment with antibiotics or similar medicines.
  • 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 adequate 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.

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
5 December 2016
Est. completion
5 July 2018

Where this trial is recruiting

🇧🇬 Bulgaria 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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?

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