Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps
(WAYPOINT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing an injectable medication called tezepelumab in adults with severe sinus inflammation and nasal polyps. The medication aims to reduce swelling and polyp growth by calming the immune system. Tezepelumab has been previously studied and shown to improve outcomes in patients with severe, uncontrolled asthma.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like decongestants and immunosuppressive drugs, before joining the trial. It's best to discuss your current medications with the trial team to see if any changes are needed.
Is Tezepelumab safe for humans?
How is the drug Tezepelumab different from other treatments for chronic rhinosinusitis with nasal polyps?
Tezepelumab is unique because it is a monoclonal antibody that blocks thymic stromal lymphopoietin, a protein involved in inflammation, which is different from other treatments like mepolizumab that target interleukin-5. This mechanism may offer a new approach for patients with chronic rhinosinusitis with nasal polyps, especially those who also have severe asthma.45678
What data supports the effectiveness of the drug Tezepelumab for treating chronic rhinosinusitis with nasal polyps?
Tezepelumab has shown effectiveness in reducing asthma symptoms, which is relevant because similar drugs targeting type 2 inflammation have improved nasal polyp scores and health status in patients with chronic rhinosinusitis with nasal polyps. This suggests Tezepelumab might also be beneficial for this condition.34569
Who Is on the Research Team?
Brian Lipworth, MD
Principal Investigator
University of Dundee
Joseph K Han, MD
Principal Investigator
Eastern Virginia Medical School
Are You a Good Fit for This Trial?
This trial is for people with severe chronic rhinosinusitis and nasal polyps, who've had symptoms like runny nose or loss of smell for over 8 weeks. They should have a history of sinus issues needing steroids or surgery but haven't used certain meds in the last 3 months. Those recently vaccinated for COVID-19 or with other serious lung conditions can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tezepelumab or placebo via subcutaneous injection over a 52-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tezepelumab
Tezepelumab is already approved in United States, European Union for the following indications:
- Severe asthma
- Severe asthma
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London