← Back to Search

Monoclonal Antibodies

Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps (WAYPOINT Trial)

Phase 3
Waitlist Available
Led By Joseph K Han, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented treatment of nasal polyposis exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 and/or any history of NP surgery (or contraindications/intolerance to)
Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader
Must not have
Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure
Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, systemic corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 and during the study period. Systemic corticosteroid use is defined as treatment with a burst of systemic corticosteroids for at least 3 consecutive days or a single IM depo-injectable dose of corticosteroids (considered equivalent to a 3-day burst of systemic corticosteroids)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 52 weeks
Awards & highlights
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests Tezepelumab's effectiveness and safety against a placebo in participants with severe sinus issues due to nasal polyps. It's randomized, meaning participants are put into the Tezepelumab or placebo group by chance, and double-blind so neither doctors nor patients know who gets what.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include injection site reactions, headache, fatigue, and potential worsening of existing allergies or asthma. Participants will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've been treated for nasal polyps with steroids or had surgery for it in the last year, but not in the last 3 months.
Select...
My nose problem is severe enough to need surgery, based on a specific test score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not regularly use decongestants, except for endoscopic procedures.
Select...
I haven't taken any immunosuppressive drugs in the last 3 months.
Select...
I have no major health issues affecting my lungs except for asthma.
Select...
I have not had sinus surgery in the last 6 months or any that altered the side wall of my nose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Nasal Polyp-Quality of Life Compared with Placebo
Nasal Polyposis Surgery and/or Receiving Systemic Corticosteroids for Nasal Polyposis
Nasal Polyposis Symptom Diary Total Symptom Score
+1 more
Other study objectives
Asthma Control in Participants with Comorbid Asthma and Aspirin Exacerbated Respiratory Disease (AERD)/Nonsteroidal Anti-Inflammatory Drug Exacerbated Respiratory Disease (NSAID-ERD)
Immunogenicity anti-drug antibodies
Loss of Smell
+7 more

Side effects data

From 2020 Phase 3 trial • 1061 Patients • NCT03347279
21%
Nasopharyngitis
11%
Upper respiratory tract infection
8%
Headache
5%
Bronchitis bacterial
5%
Bronchitis
4%
Urinary tract infection
4%
Sinusitis
4%
Back pain
4%
Arthralgia
4%
Influenza like illness
4%
Hypertension
3%
Gastroenteritis
3%
Viral upper respiratory tract infection
3%
Pharyngitis
3%
Rhinitis
3%
Asthma
3%
Rhinitis allergic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Tezepelumab 210mg Q4W

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TezepelumabExperimental Treatment1 Intervention
Tezepelumab subcutaneous injection, in an accessorized pre-filled syringe.
Group II: PlaceboPlacebo Group1 Intervention
Placebo subcutaneous injection, in an accessorized pre-filled syringe.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental: Tezepelumab
2019
Completed Phase 3
~1520

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Rhinosinusitis (CRS) target key cytokines involved in the inflammatory response. Tezepelumab, for example, inhibits thymic stromal lymphopoietin (TSLP), reducing inflammation and improving symptoms. Other treatments, such as IL-5 inhibitors (mepolizumab, benralizumab) and IL-4/IL-13 blockers (dupilumab), also reduce type 2 inflammation. These therapies are crucial for CRS patients as they address the underlying inflammation, leading to better symptom control and enhanced quality of life.
Pathways analysis of molecular markers in chronic sinusitis with polyps.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,379 Previous Clinical Trials
288,739,874 Total Patients Enrolled
AmgenIndustry Sponsor
1,428 Previous Clinical Trials
1,384,359 Total Patients Enrolled
Joseph K Han, MDPrincipal InvestigatorEastern Virginia Medical School
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Tezepelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04851964 — Phase 3
Chronic Rhinosinusitis Research Study Groups: Tezepelumab, Placebo
Chronic Rhinosinusitis Clinical Trial 2023: Tezepelumab Highlights & Side Effects. Trial Name: NCT04851964 — Phase 3
Tezepelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851964 — Phase 3
~92 spots leftby Oct 2025