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Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (DIRECTION)

Primary Purpose

Asthma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Experimental: Tezepelumab
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age. 18-80
  • Documented physician-diagnosed asthma for at least 12 months
  • Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
  • Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
  • At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
  • Morning pre-BD FEV1 <80% predicted normal
  • Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
  • Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
  • ACQ-6 score ≥1.5 at screening and on day of randomization

Exclusion Criteria:

  • Pulmonary disease other than asthma.
  • History of cancer.
  • History of a clinically significant infection.
  • Current smokers or subjects with smoking history ≥10 pack-yrs.
  • History of chronic alcohol or drug abuse within 12 months.
  • Hepatitis B, C or HIV.
  • Pregnant or breastfeeding.
  • History of anaphylaxis following any biologic therapy.
  • Subject randomized in the current study or previous tezepelumab studies.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tezepelumab

Placebo

Arm Description

Tezepelumab: Tezepelumab subcutaneous injection

Placebo: Placebo subcutaneous injection

Outcomes

Primary Outcome Measures

Annualized asthma exacerbation rate (AERR)
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks.

Secondary Outcome Measures

Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) total score
Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma participants. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Mean change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Change from baseline in weekly mean daily Asthma Symptom Diary score
Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.
Time to first asthma exacerbation
Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF
Change from baseline in fractional exhaled nitric oxide
Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers
Change from baseline in weekly mean rescue medication use
Mean change from baseline in weekly mean rescue medication use at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. The number of rescue medication inhalations (puffs) and nebulizer treatments taken will be recorded by the participant in the Asthma Symptom Diary twice daily (i.e., in the morning and evening). Each timepoint is calculated as weekly means based on daily diary data.
Number of participants with asthma specific resource utilization (e.g.,eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications)
Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks.
Serum trough concentrations
Serum trough concentrations (pre-dose samples) at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab
European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score
Mean change from baseline in EQ-5D-5L at week 52. EQ-5D-5L has two sections. The first section assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from "no problem," "slight problem" "moderate problem", "severe problem" and "unable". A composite health index is defined by combining the levels for each dimension. The second section measures self-rated (global) health status using a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible health state". EQ-5D-5L assesses health status in terms of a single index value or health utility score. It allows "weighting" by the patient of particular health states and the generation of patient utilities. Overall scores range from 0 to 1,with lower scores representing a higher level of dysfunction.
Change from baseline in peripheral blood eosinophils
Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.
Change from baseline in total serum IgE
Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Mean change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. Home PEF testing will be performed by the participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly means.
Change from baseline in weekly mean number of night time awakenings
Mean change from baseline in weekly mean number of night time awakenings at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. Each timepoint is calculated as weekly mean number of awakenings due to asthma based on daily diary data. Weekly mean number of night time awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%.
Immunogenicity anti-drug antibodies
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.
Proportion of participants who did not experience an asthma exacerbation
Percentage of participants who did not experience an asthma exacerbation as compared to placebo at Week 52
Annualized rate of exacerbations associated with emergency room (ER) visit or hospitalizations
Annualized rate of exacerbations associated with ER visit or hospitalization as compared to placebo over 52 weeks

Full Information

First Posted
April 23, 2019
Last Updated
September 4, 2023
Sponsor
AstraZeneca
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03927157
Brief Title
Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma
Acronym
DIRECTION
Official Title
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults With Severe Uncontrolled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
August 19, 2024 (Anticipated)
Study Completion Date
August 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma
Detailed Description
This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 participants will be randomized regionally (China/non-China). Participants will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tezepelumab
Arm Type
Experimental
Arm Description
Tezepelumab: Tezepelumab subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: Placebo subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Experimental: Tezepelumab
Other Intervention Name(s)
Tezepelumab
Intervention Description
Tezepelumab subcutaneous injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection
Primary Outcome Measure Information:
Title
Annualized asthma exacerbation rate (AERR)
Description
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks.
Time Frame
Randomization to Week 52
Secondary Outcome Measure Information:
Title
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Description
Mean change from baseline in FEV1 as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Time Frame
Randomization, Week 52
Title
Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12) total score
Description
Mean change from baseline in AQLQ(S)+12 as compared to placebo at Week 52. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma participants. The total score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment).
Time Frame
Randomization， Week 52
Title
Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) Score
Description
Mean change from baseline in ACQ-6 as compared to placebo at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2-agonist use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Time Frame
Randomization, Week 52
Title
Change from baseline in weekly mean daily Asthma Symptom Diary score
Description
Mean change from baseline in Asthma Symptom Diary score as compared to placebo at Week 52. The Asthma Symptom Diary comprises of 10 items (5 items in the morning; 5 items in the evening). Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the daily diary. A daily ASD score is the mean of the 10 items. Responses for all 10 items are required to calculate the daily ASD score; otherwise, it is treated as missing. For the 7-day average asthma symptom score, scoring is done with no imputation using the mean of at least 4 of the 7 daily ASD scores as a mean weekly item score. The 7-day average ASD score ranges from 0 to 4.
Time Frame
Randomization, Week 52
Title
Time to first asthma exacerbation
Description
Time to the first occurrence of asthma exacerbation post randomization, presented as number of participants with at least one asthma exacerbation reported in the eCRF
Time Frame
Randomization to Week 52
Title
Change from baseline in fractional exhaled nitric oxide
Description
Mean change from baseline in FENO (ppb) at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers
Time Frame
Randomization, Week 52
Title
Change from baseline in weekly mean rescue medication use
Description
Mean change from baseline in weekly mean rescue medication use at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. The number of rescue medication inhalations (puffs) and nebulizer treatments taken will be recorded by the participant in the Asthma Symptom Diary twice daily (i.e., in the morning and evening). Each timepoint is calculated as weekly means based on daily diary data.
Time Frame
Randomization, Week 52
Title
Number of participants with asthma specific resource utilization (e.g.,eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications)
Description
Number of participants with asthma specific resource utilization (e.g. unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) over 52 weeks.
Time Frame
Randomization to Week 52
Title
Serum trough concentrations
Description
Serum trough concentrations (pre-dose samples) at each scheduled visit to evaluate the pharmacokinetics (PK) of tezepelumab
Time Frame
Baseline to Week 64
Title
European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score
Description
Mean change from baseline in EQ-5D-5L at week 52. EQ-5D-5L has two sections. The first section assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from "no problem," "slight problem" "moderate problem", "severe problem" and "unable". A composite health index is defined by combining the levels for each dimension. The second section measures self-rated (global) health status using a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible health state". EQ-5D-5L assesses health status in terms of a single index value or health utility score. It allows "weighting" by the patient of particular health states and the generation of patient utilities. Overall scores range from 0 to 1,with lower scores representing a higher level of dysfunction.
Time Frame
Randomization, Week 52
Title
Change from baseline in peripheral blood eosinophils
Description
Mean change from baseline in blood eosinophil counts at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.
Time Frame
Randomization, Week 52
Title
Change from baseline in total serum IgE
Description
Mean change from baseline in IgE at week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on biomarkers.
Time Frame
Randomization, Week 52
Title
Change from baseline in weekly mean morning and evening peak expiratory flow (PEF)
Description
Mean change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. Home PEF testing will be performed by the participant in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Each timepoint is calculated as weekly means.
Time Frame
Randomization, Week 52
Title
Change from baseline in weekly mean number of night time awakenings
Description
Mean change from baseline in weekly mean number of night time awakenings at Week 52 to assess the effect of 210 mg of tezepelumab SC Q4W on other asthma control metrics. Each timepoint is calculated as weekly mean number of awakenings due to asthma based on daily diary data. Weekly mean number of night time awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data and multiplied by 100%.
Time Frame
Randomization, Week 52
Title
Immunogenicity anti-drug antibodies
Description
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. Treatment emergent ADA defined as sum of treatment induced ADA and treatment boosted ADA.
Time Frame
Baseline to Week 64
Title
Proportion of participants who did not experience an asthma exacerbation
Description
Percentage of participants who did not experience an asthma exacerbation as compared to placebo at Week 52
Time Frame
Week 52
Title
Annualized rate of exacerbations associated with emergency room (ER) visit or hospitalizations
Description
Annualized rate of exacerbations associated with ER visit or hospitalization as compared to placebo over 52 weeks
Time Frame
Randomization to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age. 18-80 Documented physician-diagnosed asthma for at least 12 months Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months. Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. Morning pre-BD FEV1 <80% predicted normal Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening. Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS. ACQ-6 score ≥1.5 at screening and on day of randomization Exclusion Criteria: Pulmonary disease other than asthma. History of cancer. History of a clinically significant infection. Current smokers or participants with smoking history ≥10 pack-yrs. History of chronic alcohol or drug abuse within 12 months. Hepatitis B, C or HIV. Pregnant or breastfeeding. History of anaphylaxis following any biologic therapy. participant randomized in the current study or previous tezepelumab studies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong, Bachelor
Organizational Affiliation
Guangzhou institute of Respiratory Disease, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Baotou
ZIP/Postal Code
14010
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
1000096
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Research Site
City
Chongqing
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Research Site
City
Guangzhou
Country
China
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
550004
Country
China
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
133500
Country
China
Facility Name
Research Site
City
Hengyang
ZIP/Postal Code
50012
Country
China
Facility Name
Research Site
City
Hohhot
ZIP/Postal Code
010017
Country
China
Facility Name
Research Site
City
Hohhot
ZIP/Postal Code
10050
Country
China
Facility Name
Research Site
City
Huzhou
ZIP/Postal Code
313003
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Research Site
City
Jinhua
ZIP/Postal Code
321000
Country
China
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Facility Name
Research Site
City
Linhai
ZIP/Postal Code
317000
Country
China
Facility Name
Research Site
City
Linyi
ZIP/Postal Code
CN-276003
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
2100008
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530007
Country
China
Facility Name
Research Site
City
Quanzhou
ZIP/Postal Code
362000
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Research Site
City
Shengyang
ZIP/Postal Code
110004
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110015
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518035
Country
China
Facility Name
Research Site
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Research Site
City
Urumchi
ZIP/Postal Code
830054
Country
China
Facility Name
Research Site
City
Weifang
ZIP/Postal Code
261041
Country
China
Facility Name
Research Site
City
Wenzhou
ZIP/Postal Code
325027
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430033
Country
China
Facility Name
Research Site
City
Xi'an
ZIP/Postal Code
710004
Country
China
Facility Name
Research Site
City
Xining
ZIP/Postal Code
810007
Country
China
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221000
Country
China
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221009
Country
China
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Facility Name
Research Site
City
Zhuhai
ZIP/Postal Code
519099
Country
China
Facility Name
Research Site
City
Zibo
Country
China
Facility Name
Research Site
City
Zunyi
ZIP/Postal Code
563100
Country
China
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Research Site
City
Jeonju-si
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 rerefer 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

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