Have you been diagnosed with both severe chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma? If so, you may be eligible for a clinical study looking for people over the age of 18 with severe CRSwNP along with asthma who have symptoms of nasal congestion and loss of smell.
This clinical study will compare the effects of two different medicines, dupilumab and omalizumab, which are already approved to treat certain medical conditions including asthma and nasal polyps. Your participation in this study will help researchers learn if one medicine works better than the other to treat certain symptoms, including: reduced nasal polyp size, improved sense of smell, reduced nasal congestion, improvements in how well the lungs and nose work, and improved overall quality of life.
Both dupilumab and omalizumab are:
- Antibody therapies: Antibodies are proteins which are made naturally in our bodies with many purposes, for example, to protect us from viruses. Antibodies can also be made in the laboratory and turned into medications called “biologics” which includes specially designed antibodies programmed to stop the immune system from causing inflammation.
- Injectables: medications that are injected just under the skin (“subcutaneous” injections).
- Approved for use in many countries worldwide including the United States to treat adults with CRSwNP and children and adults with asthma.
How long is the study?
The study will last approximately 28 weeks (7 months).
- Screening period: up to 4 weeks (1 month)
- Treatment period: up to 24 weeks (6 months)
- Follow-up period: up to 12 weeks (3 months)
How many visits will there be?
The study will have 14 visits:
- 1 visit during the screening period to allow your doctor to confirm if you are eligible.
- 13 visits during the treatment period to see how the medication is working.
- 1 visit (phone call) during the end-of-study period to follow-up after treatments have ended to assess your safety and well-being.
How many people are in the study?
This study will include approximately 420 participants across 17 countries.