Dupilumab for Prevention of Recurrence of CRSwNP After ESS

"The Dupilumab will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction.~Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas), the upper thighs or the upper arms, so that the same site is not injected twice consecutively. Injection in the upper arms could be done only by a trained person (caregiver trained by Investigator or Delegate) or health care professional but not the patients themselves."

"The Placebo will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction.~Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas), the upper thighs or the upper arms, so that the same site is not injected twice consecutively. Injection in the upper arms could be done only by a trained person (caregiver trained by Investigator or Delegate) or health care professional but not the patients themselves."

On a daily basis throughout the study, the patient will use a paper diary to record daily use of mometasone furoate nasal spray (MFNS) 50 μg/actuation nasal spray, suspension (refer to the package insert \& SmPC for a description, administration details and precautions for use). MFNS is provided in a bottle that contains 18 g (140 actuations) of product formulation. If patient is unable to tolerate 200 micrograms twice a day (total dose 400 micrograms) due to experiencing adverse event, patient may reduce dose to 200 micrograms once per day.