Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Biological: Experimental: Tezepelumab; Other: Placebo; Drug: Mometasone furoate or equivalent intranasal corticosteroid

Detailed Description

This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults with severe, chronic rhinosinusitis with nasal polyposis. Approximately 400 subjects will be randomized globally. Participants will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS) every 4 weeks, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12-24 weeks for participants who complete the 52-week treatment period. All participants will have background mometasone furoate nasal spray or equivalent intranasal corticosteroid at a stable dose from Visit 1 and throughout the screening and study period.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1G5
      • Research Site
    • London, Ontario, Canada, N6A 4V2
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
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    • Montreal, Quebec, Canada, H2X 0A9
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    • Montreal, Quebec, Canada, H2V 2K1
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    • Québec, Quebec, Canada, G1S 4L8
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    • Québec, Quebec, Canada, G1V 4G5
      • Research Site
    • Québec, Quebec, Canada, G1V 4W2
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    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • Research Site
• China
  • Bengbu, China, 233004
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  • Chengdu, China, 610072
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  • Guangzhou, China, 510120
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  • Hangzhou, China, 310003
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  • Hangzhou, China, 310014
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  • Hengyang, China, 421001
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  • Lanzhou, China, 730030
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  • Nanchang, China, 330006
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  • Nanjing, China, 210009
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  • Qingdao, China, 266011
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  • Shanghai, China, 200433
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  • Shanghai, China, 200031
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  • Suzhou, China, 215006
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  • Taizhou, China, 225300
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  • Tianjin, China, 300211
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  • Tianjin, China, 300121
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  • Wenzhou, China, 325027
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  • Wuhan, China, 430060
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  • Xi'an, China, 710068
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  • Yinchuan, China, 750001
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  • Zunyi, China, 563100
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• Denmark
  • Aalborg, Denmark, 9000
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  • Aarhus N, Denmark, 8200
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  • Hillerød, Denmark, 3400
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  • Hvidovre, Denmark, 2650
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  • København NV, Denmark, 2400
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  • Køge, Denmark, 4600
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  • Odense, Denmark, 5000
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  • Vejle, Denmark, 7100
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• Germany
  • Berlin, Germany, 10629
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  • Berlin, Germany, 13353
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  • Dresden, Germany, 01307
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  • Heidelberg, Germany, 69120
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  • Lübeck, Germany, 23538
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  • Marburg, Germany, 35043
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  • Tübingen, Germany, 72076
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  • Wiesbaden, Germany, 65183
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• Hungary
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1134
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  • Budapest, Hungary, 1046
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  • Nyíregyháza, Hungary, 4400
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  • Pécs, Hungary, 7621
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  • Siófok, Hungary, 8600
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8431
    • Research Site
  • Chuo-shi, Japan, 409-3898
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  • Habikino-shi, Japan, 583-0886
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  • Ichikawa-shi, Japan, 272-0111
    • Research Site
  • Itabashi-ku, Japan, 173-8610
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  • Kashiwa-shi, Japan, 277-0882
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  • Kisarazu-shi, Japan, 292-8535
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  • Miyazaki, Japan, 880-8510
    • Research Site
  • Nagaoka-shi, Japan, 940-8621
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  • Nerima-ku, Japan, 177-0035
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  • Niigata, Japan, 951-8520
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  • Osaka, Japan, 553-0003
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  • Saitama-shi, Japan, 336-8522
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  • Sapporo, Japan, 003-0022
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  • Sendai, Japan, 983-8512
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  • Suwa-shi, Japan, 392-8510
    • Research Site
  • Toyonaka Shi, Japan, 560-0082
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  • Yokohama, Japan, 236-0037
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  • Yokohama, Japan, 227-8501
    • Research Site
• Poland
  • Bialystok, Poland, 15-879
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  • Bydgoszcz, Poland, 85-231
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  • Krakow, Poland, 31-513
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  • Nadarzyn, Poland, 05-830
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  • Wroclaw, Poland, 50-556
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  • Wroclaw, Poland, 53-301
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  • Zawadzkie, Poland, 47-120
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  • Łodź, Poland, 90-153
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• Spain
  • Barakaldo, Spain, 48903
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  • Barcelona, Spain, 08036
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  • Jerez de la Frontera, Spain, 11407
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  • Madrid, Spain, 28040
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  • Santiago de Compostela, Spain, 15706
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  • Seville, Spain, 41009
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• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
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  • London, United Kingdom, SE1 9RT
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  • Manchester, United Kingdom, M13 9WL
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  • Stockport, United Kingdom, SK2 7JE
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• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Research Site
  • California
    • Bakersfield, California, United States, 93301
      • Research Site
    • Newport Beach, California, United States, 92663
      • Research Site
    • Roseville, California, United States, 95661
      • Research Site
    • Walnut Creek, California, United States, 94598
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  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Research Site
    • Denver, Colorado, United States, 80230
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  • Florida
    • Boca Raton, Florida, United States, 33487
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Research Site
    • White Marsh, Maryland, United States, 21162
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
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  • Missouri
    • Columbia, Missouri, United States, 65212
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  • New York
    • New York, New York, United States, 10003
      • Research Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
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  • South Carolina
    • North Charleston, South Carolina, United States, 29406
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  • Texas
    • Dallas, Texas, United States, 75231
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  • Virginia
    • Norfolk, Virginia, United States, 23507
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  • Washington
    • Spokane, Washington, United States, 99201
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  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53228
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have:

   1. Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader
   2. Nasal Congestion Score (NCS) ≥ 2 at Visit 1
   3. Ongoing documented NP symptoms over > 8 weeks prior to screening such as rhinorrhea and/or reduction/loss of smell
2. SNOT-22 total score ≥ 30 at screening (Visit 1)
3. Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to Visit 1
4. 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)

Exclusion Criteria:

1. Any clinically important comorbidities other than asthma (e.g. active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc.) that could confound interpretation of clinical efficacy results.
2. Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.
3. Positive COVID-19 PCR test (or COVID-19 rapid test) or COVID-19 entry screening questionnaire during the screening visit. Evaluation will be based on on local standard of care as determined by current local guidelines.
4. Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure
5. 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).
6. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform) 28 days prior to date of IP administration at Visit 3 (randomisation visit).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tezepelumab; Tezepelumab subcutaneous injection in an accessorized pre-filled syringe every 4 weeks (Q4W) added to background mometasone furoate (MFNS) or equivalent intranasal corticosteroid (INCS).	Biological: Experimental: Tezepelumab; Tezepelumab subcutaneous injection; Other Names: Tezepelumab; Drug: Mometasone furoate or equivalent intranasal corticosteroid; Background MFNS or equivalent INCS at stable dose
Placebo Comparator: Placebo; Placebo subcutaneous injection in an accessorized pre-filled syringe Q4W added to background MFNS or equivalent INCS.	Other: Placebo; Placebo subcutaneous injection; Drug: Mometasone furoate or equivalent intranasal corticosteroid; Background MFNS or equivalent INCS at stable dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Nasal Polyp Score at Week 52	The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.	Baseline to Week 52
Change From Baseline in Bi-weekly Mean Nasal Congestion Score (NCS) at Week 52	The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing.	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Bi-weekly Mean Loss of Smell at Week 52	Participant reported sense of smell will be evaluated as part of the NPSD. Loss of smell is captured by the DSS item (difficulty with sense of smell) in the NPSD asking participants to rate the severity of their worst difficulty with sense of smell over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses to the from Day -13 to Day 0. Bi-weekly (14-day) mean loss of smell will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing.	Baseline to Week 52
Change From Baseline in SinoNasal Outcome Test 22 (SNOT-22) at Week 52	SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).	Baseline to Week 52
Change From Baseline in Lund Mackay Score Evaluated by CT at Week 52.	The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes).	Week 52
Percentage of Participants With Nasal Polyp Surgery Decision and/or Systemic Corticosteroid for Nasal Polyposis up to Week 52	Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Rescue treatment of NP is defined as requiring treatment with systemic corticosteroids (SCS) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids). Time to first NP surgery decision or SCS for NP = (date of the first NP surgery decision or start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group.	Up to Week 52
Percentage of Participants With Nasal Polyp Surgery Decision up to Week 52	Surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g., polypectomy, endoscopic sinus surgery). Time to first NP surgery decision = (date of the first NP surgery decision - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group.	Up to Week 52
Percentage of Participants With Systemic Corticosteroids for Nasal Polyposis up to Week 52	Systemic corticosteroids (SCS) for nasal polyposis (NP) is defined as requiring at least 3 consecutive days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of SCS) for NP. Time to first SCS for NP = (start date of first SCS for NP use - date of randomisation)+1. Kaplan Meier estimates of percentage of participants with events and 95% confidence interval are provided for each treatment group.	Up to Week 52
Change From Baseline in Bi-weekly Mean Nasal Polyposis Symptom Diary Total Symptom Score at Week 52	The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity.	Baseline to Week 52
Change From Baseline in Pre-bronchodilator Forced Expiratory Volume (L) in 1 Second at Week 52.	For participants with comorbid asthma and aspirin exacerbated respiratory disease (AERD)/nonsteroidal anti-inflammatory drug exacerbated respiratory disease (NSAID-ERD), difference in change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) in the tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.	Baseline to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Over Time in Nasal Polyp Score Through Week 52.	The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.	Baseline to Week 52
Proportion of Participants With ≥1 Point Reduction in the Nasal Polyp Score at Week 52	The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥1 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder.	Baseline to Week 52
Proportion of Participants With ≥2 Point Reduction in the Nasal Polyp Score at Week 52	The Nasal Polyp Score is the sum of the right and left nostril scores (maximum 8), as evaluated by nasal endoscopy. A participant with ≥2 point reduction in NPS at Week 52 in the absence of SCS for NP, biologic for NP, or NP surgery at or prior to that time point was defined as a responder, otherwise the participant was defined as a non-responder.	Baseline to Week 52
Change From Baseline Over Time in Bi-weekly Mean Nasal Congestion Score Evaluated by Nasal Polyposis Symptom Diary Through Week 52.	The NCS is captured by one item in the NPSD (nasal polyps symptom diary) asking participants to rate the severity of their worst NC over the past 24 hours using the following response options: 0 - None; 1 - Mild; 2 - Moderate; 3 - Severe. Baseline will be the mean of daily responses from Day -13 to Day 0. Bi-weekly (14-day) mean NCS will be calculated if at least 8 days in each 14-day period has evaluable data; otherwise the bi-weekly mean is set to missing.	Baseline to Week 52
Change From Baseline in Loss of Smell Evaluated by University of Pennsylvania Smell Identification Test (UPSIT) at Week 52.	The University of Pennsylvania Smell Identification Test is a quantitative test of olfactory function which uses microencapsulated odorants that are released by scratching standardized odour-impregnated test booklets. Scores are based on number of correctly identified odours (score range 0-40, lower scores indicate poorer outcomes).	Baseline to Week 52
Change From Baseline in Modified Lund Mackay Score Evaluated by CT at Week 52.	The Modified Lund-Mackay score scoring system was used to provide a semi-quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal) on each side were scored. Each sinus on each side was scored based on the percentage of opacification from mucosal thickening according to matrix: (score 0 for 0% Opacification; score 1 for 1-25% Opacification; score 2 for 26-50% Opacification; score 3 for 51-75% Opacification; score 4 for 76-99% Opacification; score 5 for 100% Opacification). The range of total Modified Lund Mackay score is from 0 to 50. Higher scores indicate greater symptom severity.	Baseline to Week 52
Change From Baseline in Sinus Severity Score by Quantitative CT Assessment at Week 52	Quantitative assessment of sinus CT image data were used to derive an objective measure of sinus disease burden called sinus severity score. The sinus severity score is defined as: (sinus mucosal volume)/(sinus mucosal volume + sinus air volume)×100%. The range of sinus severity score is 0 to 100. Higher scores indicate greater symptom severity.	Baseline to Week 52
Exposure of Systemic Corticosteroids Over 52 Weeks	The number of courses of SCS for NP per year was analysed using a negative binomial model. The response variable was the number of courses of SCS for NP received by a participant over the planned treatment period. The model included treatment group, baseline co-morbid asthma/AERD/NSAID-ERD status, prior NP surgery status, and region as factors. The logarithm of the time at risk (in years) was used as an offset variable, to adjust different follow-up times. Time during a course was not included in the calculation of time at risk.	Over 52 weeks
Change From Baseline by Domain of the Nasal Polyposis Symptom Diary Through Week 52	The participant will complete an 11-item nasal polyposis symptom diary each morning throughout the screening, treatment and follow-up periods. The participant is asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants are asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, and difficulty with sense of smell) and symptom impacts (difficulty with sleeping due to nasal symptoms and difficulty with daily activities due to nasal symptoms). Participants report the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe).	Baseline to Week 52
Change From Baseline in Nasal Peak Inspiratory Flow Through Week 52.	Nasal peak inspiratory flow evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute.	Baseline to Week 52
Change From Baseline in Asthma Control Questionnaire-6 at Week 52.	The Asthma Control Questionnaire is an assessment of asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short acting beta-agonist use). Participants are asked to recall their level of asthma control during the previous week by responding to one bronchodilator use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).	Baseline to Week 52
Tezepelumab Pharmacokinetics	Serum concentrations of tezepelumab through Week 64. Logarithm transformation was used when calculating geometric mean of serum concentrations. The results were transformed back to original scale.	Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, and Week 64
Immunogenicity of Tezepelumab for Non-China Subjects	Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.	Pre-dose samples at Baseline to Week 64
Immunogenicity of Tezepelumab for China Subjects	Anti-drug antibodies (ADA) responses at baseline and post-baseline. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA.	Pre-dose samples at Baseline to Week 64

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Amgen
• Investigators: Principal Investigator: Joseph K Han, MD, Eastern Virginia Medical School; Principal Investigator: Brian Lipworth, MD, University of Dundee

Publications and helpful links

General Publications

• Lipworth BJ, Han JK, Desrosiers M, Hopkins C, Lee SE, Mullol J, Pfaar O, Li T, Chen C, Almqvist G, Margolis MK, McLaren J, Jagadeesh S, MacKay J, Megally A, Hellqvist A, Mankad VS, Bahadori L, Ponnarambil SS; WAYPOINT Study Investigators. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2025 Mar 27;392(12):1178-1188. doi: 10.1056/NEJMoa2414482. Epub 2025 Mar 1.

Helpful Links

• D5242C00001_CSP_redacted
• D5242C00001_SAP_redacted
• D5242C00001_CSR Synopsis_redacted

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Chronic rhinosinusitis with nasal polyps; Nasal polyps; Nasal polyposis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Signs and Symptoms; Nasal Polyps; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Mometasone Furoate
• Other Study ID Numbers: D5242C00001; 2020-003062-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No