Chronic Rhinosinusitis With Nasal PolypsPhase 3BIFANGNCT07520162
A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
A Phase 3 study testing Tezepelumab in people with Chronic Rhinosinusitis With Nasal Polyps, run by AstraZeneca at 34 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Tezepelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 34 sitesChina
- Study dates
- 24 Apr 2026to 7 Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age
- 1. 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
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- 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.
- 4. 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).
- 5. 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:
- Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels within the postmenopausal range.
- Women > 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
- WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:
- Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)
- Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
- Cessation of contraception after this point should be discussed with a responsible physician.
- Informed Consent 8. Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses.
Who cannot join
- 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
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- 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
- Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1
- Uncontrolled epistaxis within 2 months of Visit 1.
- A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
- For participants with comorbid asthma: Current smokers or participants with a smoking history > 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 packs per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
- History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
- Tuberculosis requiring treatment within the 12 months prior to Visit 1. Particpiants who in the opinion of the investigator have evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. Evaluation will be according to the local standard of care as determined by local guidelines and may consist of medical history and physical examinations, chest x-ray, sputum stain and/or culture, and/or TB test (eg, purified protein derivative or QuantiFeron test).
- Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.
- History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
- Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.
- -Prior/Concomitant Therapy
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
- Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
- Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
- Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study including the follow-up period.
- Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
- History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
- Regular use of decongestants (topical or systemic) from Visit 1 onward is not allowed unless used for endoscopic procedure.
- Use of corticosteroid-eluting intranasal stents within 6 months prior to Visit 1 and during the study period.
- Recent aspirin desensitisation within 6 months of enrolment.
- -Prior/Concurrent Clinical Study Experience
- Concurrent enrolment in another clinical study involving a study intervention.
- -Diagnostic Assessments
- Any clinically meaningful abnormal finding in physical examination, haematology, or clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
- Evidence of active liver disease, including jaundice or AST, ALT, or ALP > 2 times ULN at Visit 1.
- Positive hepatitis B surface antigen, or hepatitis C antibody serology at screening, or a positive medical history for hepatitis B or C. Participants with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.
- -Other Exclusions
- Participants with JESREC score of <11
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site), or participants employed by or relatives of the relatives of the employees of the site or sponsor.
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancy test must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the tezepelumab, a participant may be enrolled on the basis of a negative urine pregnancy test, though serum β-HCG must still be obtained. If either test is positive, the participant should be excluded. Since urine and serum tests may miss a pregnancy in the first days after conception, relevant menstrual history and sexual history, including methods of contraception, should be considered. Any participant whose menstrual and/or sexual history suggests the possibility of early pregnancy should be excluded.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Research Site
Beijing, 100034
- Recruiting
Research Site
Beijing, 100730
- Recruiting
Research Site
Bengbu, 233004
- Recruiting
Research Site
Cangzhou, 061000
- Recruiting
Research Site
Changsha, 410011
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Chengdu, 610021
- Recruiting
Research Site
Chengdu, 610041
- Recruiting
Research Site
Chengdu, 610075
- Recruiting
Research Site
Chengdu, 610078
- Recruiting
Research Site
Chongqing, 400016
- Recruiting
Research Site
Foshan, 528000
- Recruiting
Research Site
Fuzhou, 350005
- Recruiting
Research Site
Guangzhou, 510120
- Recruiting
Research Site
Guiyang, 550044
- Recruiting
Research Site
Huaian, 223300
- Recruiting
Research Site
Kunming, 650032
- Recruiting
Research Site
Lanzhou, 730030
- Recruiting
Research Site
Nanchang, 330006
- Recruiting
Research Site
Nanchang, 330052
- Recruiting
Research Site
Ningbo, 315100
- Recruiting
Research Site
Qingdao, 110016
- Recruiting
Research Site
Shenyang, 110004
- Recruiting
Research Site
Shenzhen, 518039
- Recruiting
Research Site
Shijiazhuang, 50051
- Recruiting
Research Site
Taiyuan, 030001
- Recruiting
Research Site
Taizhou, 225300
- Recruiting
Research Site
Tianjin, 300192
- Recruiting
Research Site
Ürümqi, 830054
- Recruiting
Research Site
Wuhan, 430022
- Recruiting
Research Site
Wuhu, 241004
- Recruiting
Research Site
Xi'an, 710004
- Recruiting
Research Site
Yangzhou, 225000
- Recruiting
Research Site
Zibo, 255036
About this study
Official title: BIFANG: A Multicentre, 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
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.
Read the detailed description
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.
The study aims to enrol approximately 230 participants from approximately 30-50 sites in China. To ensure that participants' inflammatory endotypes of disease are represented appropriately in this study, restrictive inclusion criteria will be adopted to ensure that all participants have an eosinophilic endotype (defined by JESREC score of ≥ 11), with approximately 30% of participants having a JESREC score of ≥ 15. Eligible participants will receive tezepelumab at a fixed dose of 210 mg subcutaneously (SC) using an accessorised pre-filled syringe (APFS) every four weeks for up to 24 weeks.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Tezepelumab
- Keywords
- CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
Also called TEZSPIRE®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline-week24
Secondary outcomes (27)
To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment
Proportion of NCS responders (minimal clinically important difference [MCID] from baseline = -1.0) at each collected timepoint.
NCS: score 0-3, 3indicates worse outcome
Measured: 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
Description of time to first response for NCS. NCS: score 0-3, 3indicates worse outcome
Measured: 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
Change from baseline in NCS at each collected timepoint in daily score. NCS: score 0-3, 3indicates worse outcome
Measured: 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
Proportion of participants with (i) ≥ 1 point reduction and (ii) ≥ 2 points reduction in NPS at Week 24.
NPS: score 0-4 for each item, 4 indicates worse outcome
Measured: Baseline, Weeks 0, 4, 12, and 24
To describe time to response in NPS following initiation of tezepelumab treatment
Description of time to first response for NPS (≥ 1 point reduction) NPS: score 0-4, 4 indicates worse outcome
Measured: Baseline, Weeks 0, 4, 12, and 24
To describe changes in NPS following initiation of tezepelumab treatment
Change from baseline over time in NPS evaluated by nasal endoscopy through Week 24.
NPS: score 0-4, 4 indicates worse outcome
Measured: Baseline, Weeks 0, 4, 12, and 24
To describe numbers of CRSwNP exacerbation following initiation of tezepelumab treatment
- Description of numbers of CRSwNP exacerbation during treatment period (Week 0 to 24) at Week 24
- Description of annualized CRSwNP exacerbation rate
Measured: Baseline, Weeks 0, 4, 12, and 24
To describe responder proportion in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment
Proportion of SNOT-22 responder (MCID from baseline=-8.9) at each collected timepoint.
SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe time to first response in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment
Description of time to first response for SNOT-22. SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment
Change from baseline in SNOT-22 at each collected timepoint. SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Change from baseline visit in NB measured by PNIF. Higher PNIF values indicate improved nasal airflow.
Measured: Weeks 0, 4, 12, and 24
To describe responder proportion in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Proportion of PNIF responder (MCID from baseline = 20 L/min)
Measured: Weeks 0, 4, 12, and 24
To describe time to responder in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Description of time to first response for PNIF
Measured: Weeks 0, 4, 12, and 24
To describe responder proportion in sense of smell as evaluated as part of the NPSD
- Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24
- Changes from baseline in loss of smell at all collected time points (daily)
Measured: Baseline-Week24
To describe time to responder in sense of smell as evaluated as part of the NPSD.
- Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24
- Changes from baseline in loss of smell at all collected time points (daily)
Measured: Baseline-Week24
To describe changes in sense of smell as evaluated as part of the NPSD
- Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24
- Changes from baseline in loss of smell at all collected time points (daily)
Measured: Baseline-Week24
To describe responder proportion in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment
Proportion of SNOT-22 sleep domain responders (MCID from baseline = -2.9). SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe time to responder in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment
Description of time to first response for SNOT-22 sleep domain . SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment
Changes from baseline in SNOT-22 sleep domain score。 SNOT-22: score 0-5 for each item, 5 means worse outcome
Measured: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe responder proportion in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab
Proportion of TSS responder (MCID from baseline = -4.0)
Measured: Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe time to responder in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab
Description of time to first response for TSS
Measured: Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe changes in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab
Changes from baseline in TSS in daily score
Measured: Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe the change on sinus opacification following initiation of tezepelumab.
Change from baseline in Lund-Mackay score (LMK) evaluated by CT at Week 24 as determined by the central reader.
Lund-Mackay score: 0-12 each item, 12 means worse outcome
Measured: Baseline, Week 24
To describe the change in lung function with co-morbid asthma following initiation of tezepelumab.
Change from baseline in pre-BD FEV1 at Week 24
Measured: Baseline, Week12, Week24
To describe the change in ACQ-5 in participants with co-morbid asthma following initiation of tezepelumab.
- Change from baseline in ACQ-5 at Week 24.
- The ACQ-5 total score is the mean of the 5 responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: Baseline and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Description of numbers of asthma exacerbation in participants with comorbid asthma during treatment period (Week 0-24) at Week 24
Measured: week0-24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Description of AAER in participants with comorbid asthma
Measured: week0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start24 Apr 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentre, Open-label, Single-Arm, Phase 3b Study
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luo Zhang, Professor, Principal investigator, Beijing Tongren Hospital, CMUChengshuo Wang, Professor, Principal investigator, Beijing Tongren Hospital, CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520162
- Sponsor's protocol ID
- D5242L00001
- Acronym
- BIFANG
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.