A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab

NCT07520162 | Recruiting Phase 3

• 1 other identifier: D5242L00001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)

Outcome Measures

Primary Outcomes (2)

• To describe changes from baseline in nasal polyp score (NPS)

  Change from baseline in total NPS evaluated by nasal endoscopy at Week 24 NPS: score 0-4 for each item, 4 indicates worse outcome

  baseline-week24

• To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)

  Change from baseline in bi-weekly mean nasal congestion score (NCS) evaluated as part of the Nasal Polyposis Symptom Diary (NPSD) at Week 24. NCS: score 0-3, 3 indicates worse outcome

  baseline-week24

Secondary Outcomes (29)

• To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment

  Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)

• To describe time to response and changes in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment

  Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)

• To describe changes in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment

  Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)

• To describe responder proportion in NPS following initiation of tezepelumab treatment

  Baseline, Weeks 0, 4, 12, and 24

• To describe time to response in NPS following initiation of tezepelumab treatment

  Baseline, Weeks 0, 4, 12, and 24

Other Outcomes (3)

• To evaluate the safety and tolerability of tezepelumab

  week0-24

• To evaluate the need for nasal polyp surgery up to Week 24

  Baseline-Week24

• To evaluate the need for SCS use up to Week 24

  Baseline-Week24

Study Arms (1)

Intervention Arm

EXPERIMENTAL

This is a multicentre, open-label, single-arm, Phase 3b study, all participants will be grouped into the same group for the study intervention.

Drug: Tezepelumab

Interventions

Tezepelumab DRUG

At Visit 2 (Week 0), participants who meet the inclusion and exclusion criteria will receive tezepelumab treatment. All participants will receive tezepelumab 210 mg SC every four weeks (Q4W) from Week 0 (Visit 2), with the last dose administered at Week 20 (Visit 7). All tezepelumab administration will occur at the study site. Each participant who completes the study without discontinuing study intervention will receive a total of 6 doses of tezepelumab.

Also known as: TEZSPIRE®

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• \. Participant must be 18 years of age or older, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics 2. Participants who are with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:
• Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader
• Mean NCS ≥ 2 in the 2 weeks prior to Visit 2
• Ongoing documented NP symptoms for \> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep
• SNOT-22 total score ≥ 30 as assessed at screening. 3. Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also ensure that participants are compliant and on a stable dose of the background INCS during study period.
• \. Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance or intolerance to surgery) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance or intolerance to surgery).
• \. Participants with JESREC score of ≥ 11.
• Weight 6. Body weight of ≥ 40 kg at Visit 1.
• Sex and Contraceptive/Barrier Requirements 7. Male and/or female
• Female participants:
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non-childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
• Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first tezepelumab administration without an alternative medical cause.
• The following age-specific requirements apply:

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
• Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.
• Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
• Affect the safety of the participant throughout the study
• Influence the findings of the study or the interpretation
• Impede the participant's ability to complete the entire duration of study
• 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.
• Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:
• Antrochoanal polyps
• Nasal septal deviation that occludes at least one nostril
• Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome
• History of cancer:
• Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Beijing, 100730, China

RECRUITING

MeSH Terms

Interventions

tezepelumab

Study Officials

• Luo Zhang, Professor

  Beijing Tongren Hospital, CMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentre, Open-label, Single-Arm, Phase 3b Study

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 9, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 7, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

Locations

CN (1)