Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04643158
Collaborator
(none)
345
47
4
21.8
7.3
0.3

Study Details

Study Description

Brief Summary

This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a Lead-in Cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 (separate inhalers or combination product) and medium dose ICS-LABA as a combination product for Part 2 at Screening.

Part 2 will be initiated for each dose level following evaluation of safety and PK at the relevant dose level in Part 1. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.

Condition or Disease Intervention/Treatment Phase
  • Drug: AZD1402
  • Drug: Placebo
  • Drug: Short acting beta agonist (SABA) (rescue medication)
  • Drug: Run-in medications (ICS-LABA combination)
Phase 2

Detailed Description

Part 1 of the study will be randomised, double blind, placebo-controlled, and conducted in parallel for the 2 lower dose levels (Part 1a) followed by an unblinded safety review and escalation to the highest dose (Part 1b) dependent on the outcome of the safety review.

Part 1a will consist of 30 participants who will be randomised 1:1:1 to receive 1 of the 2 lower AZD1402 dry power inhaler (DPI) doses (Dose 1 or Dose 2) or placebo in parallel. Part 1b will consist of 15 participants who will be randomised 2:1 to receive the highest AZD1402 DPI dose (Dose 3) or placebo.

Part 1a Lead-in Cohort

  • AZD1402 Dose 1

  • AZD1402 Dose 2

  • Placebo

Part 1b Lead-in Cohort

  • AZD1402 Dose 3

  • Placebo

Part 2 will be randomised, double blind, placebo controlled and will include approximately 300 participants randomised 2:1 (active to placebo) to evaluate 3 inhaled dose levels of AZD1402 versus placebo.

Part 2a, which includes the 2 lower dose levels (Dose 1 and Dose 2) will be started in parallel after the unblinded safety review for Part 1a. The higher dose of Dose 3 (Part 2b) will be included in Part 2 following the unblinded review of Part 1b, depending on the outcome of the safety review. Once Part 2b starts, all 3 dose levels (and placebo) may run in parallel. Part 2 will include:

  • AZD1402 Dose 1

  • AZD1402 Dose 2

  • AZD1402 Dose 3

  • Placebo

Study Design

Study Type:
Interventional
Anticipated Enrollment :
345 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Two-part Phase IIa Randomised, Double-blind, Placebo-controlled, Dose-ranging, Multi-centre Study to Assess Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered as a Dry Powder for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids
Actual Study Start Date :
Mar 12, 2021
Anticipated Primary Completion Date :
Jan 5, 2023
Anticipated Study Completion Date :
Jan 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1 and Part 2: AZD1402 Dose 1

Randomised participants will receive oral inhalation of AZD1402 Dose 1 via DPI.

Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: Short acting beta agonist (SABA) (rescue medication)
In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests. Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)

Drug: Run-in medications (ICS-LABA combination)
During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable. These drugs are used as standard of care.

Experimental: Part 1 and Part 2: AZD1402 Dose 2

Randomised participants will receive oral inhalation of AZD1402 Dose 2 via DPI.

Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: Short acting beta agonist (SABA) (rescue medication)
In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests. Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)

Drug: Run-in medications (ICS-LABA combination)
During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable. These drugs are used as standard of care.

Experimental: Part 1 and Part 2: AZD1402 Dose 3

Randomised participants will receive oral inhalation of AZD1402 Dose 3 via DPI.

Drug: AZD1402
Randomised participants will receive oral inhalation of AZD1402, via DPI.

Drug: Short acting beta agonist (SABA) (rescue medication)
In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests. Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)

Drug: Run-in medications (ICS-LABA combination)
During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable. These drugs are used as standard of care.

Placebo Comparator: Part 1 and Part 2: Placebo

Randomised participants will receive oral inhalation of matching placebo via DPI.

Drug: Placebo
Randomised participants will receive oral inhalation of matching placebo via DPI.

Drug: Short acting beta agonist (SABA) (rescue medication)
In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests. Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)

Drug: Run-in medications (ICS-LABA combination)
During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable. These drugs are used as standard of care.

Outcome Measures

Primary Outcome Measures

  1. Part 1: Number of participants with adverse events (AEs) [From Day 1 until Follow-up (Day 56 ± 4)]

    To evaluate the safety and tolerability of AZD1402 compared to placebo at different dose levels in adults with asthma controlled on medium dose ICS-LABA. Safety and tolerability variables included AEs/ adverse events of special interest (AESIs) / serious adverse events (SAEs), vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, Electrocardiograms (ECGs), Forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO).

  2. Part 2: Change from baseline in pre-bronchodilator FEV1 at Week 4 [Baseline and Week 4]

    To investigate the efficacy of inhaled AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.

Secondary Outcome Measures

  1. Part 1 and Part 2: Maximum observed serum (peak) drug concentration (Cmax) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  2. Part 1 and Part 2: Time to reach peak or maximum observed concentration or response following drug administration (tmax) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  3. Part 1 and Part 2: Observed lowest drug concentration reached before the next dose is administered (pre-dose) (Ctrough) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  4. Part 1 and Part 2: Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  5. Part 1 and Part 2: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  6. Part 1 and Part 2: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  7. Part 1 and Part 2: Area under plasma concentration-time curve in the dosing interval (AUCτ) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  8. Part 1 and Part 2: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  9. Part 1 and Part 2: Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  10. Part 1 and Part 2: Area under the plasma concentration time curve in the dosing interval τ divided by the dose administered (Dose normalised AUCτ) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  11. Part 1 and Part 2: Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  12. Part 1 and Part 2: Time of last observed (quantifiable) concentration (tlast) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  13. Part 1 and Part 2: Accumulation ratio for AUCτ (Rac AUC) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  14. Part 1 and Part 2: Accumulation ratio for Cmax (Rac Cmax) [Day 1 until Day 56 ± 4]

    To investigate the PK profile of AZD1402 (Part 1: full profile in all participants; Part 2: sparse in all, full profile in a subset of participants in each treatment arm).

  15. Part 1 and Part 2: Antidrug antibodies (ADA) titers testing for all ADA-positive samples as measure of immunogenicity [Day 1 until Day 56 ± 4]

    To investigate the immunogenicity of AZD1402.

  16. Part 2: Change from baseline in pre bronchodilator FEV1 average over the 4-week Treatment Period [Baseline, 4 weeks]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.

  17. Part 2: Change from baseline in post bronchodilator FEV1 average over the 4-week Treatment Period [Baseline, 4 weeks]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA.

  18. Part 2: Change from baseline in Asthma control questionnaire-6 (ACQ-6) at Week 4 and average over the Treatment Period [Baseline, Week 4]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.

  19. Part 2: Proportion of participants with a decrease in ACQ 6 score of ≥ 0.5 from baseline to Week 4 [Baseline, Week 4]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. The ACQ was developed to measure asthma control. In the ACQ-6, participants will be asked to recall how their asthma has been during the previous week by responding to one bronchodilation use question and 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicated worse outcome. The mean ACQ-6 score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and ≤ 1.5 indicate partly controlled asthma, and scores > 1.5 indicate not well-controlled asthma. Individual changes of at least 0.5 are considered clinically meaningful.

  20. Part 2: Change from baseline in St. George's respiratory questionnaire (SGRQ) score to Week 4 [Baseline, Week 4]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in asthmatics who are uncontrolled on medium dose ICS-LABA. The SGRQ is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment.

  21. Part 2: Change from baseline in average morning Peak expiratory flow (PEF) over the Treatment Period [Baseline, 4 weeks]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.

  22. Part 2: Change from baseline in average evening PEF over the Treatment Period [Baseline, 4 weeks]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Peak expiratory flow will be measured by the participant at home using a peak flow meter.

  23. Part 2: Change from baseline in daily average asthma symptom score (AM/PM) over the Treatment Period [Baseline, 4 weeks]

    To further investigate the efficacy of AZD1402 at different dose levels compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Severity scores for asthma symptoms will be recorded twice daily in the morning and evening and documented in the e-Diary. Asthma symptom scores during night-time and day-time will be assessed by the participant each morning and evening according to the following scoring system: 0: You have no asthma symptoms. You are aware of your asthma symptoms but you can easily tolerate the symptoms. Your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep). You are unable to do your normal activities (or to sleep) because of your asthma. Higher scores indicated worse outcome.

  24. Part 2: Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 4 and average over the Treatment Period [Baseline, Week 4]

    To investigate the effect of AZD1402 compared to placebo on airway inflammation in adults with asthma who are uncontrolled on medium dose ICS-LABA. To investigate the effect of AZD1402 on airway inflammation, the measurement of FeNO will be performed in accordance with ATS/ERS guidelines. Standardised conditions with regard to exhalation flow rate and duration of exhalation will be followed such that plateau definition can be evaluated over a minimum of 3 seconds. The concentration of FeNO will be measured in units of part per billion (ppb).

  25. Part 2: Number of participants with adverse events (AEs) [From Day 1 until the Follow-up (Day 56 ± 4)]

    To evaluate the safety and tolerability of AZD1402 compared to placebo in adults with asthma who are uncontrolled on medium dose ICS-LABA. Safety and tolerability variables included AEs/AESIs/SAEs, vital signs (blood pressure and pulse rate), changes in clinical chemistry, haematology, and coagulation parameters, Immuno-biomarkers, ECGs, FEV1 and FeNO.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants who have a documented clinical diagnosis of asthma for ≥ 12 months before Visit 1.

  • Participants who are able to perform acceptable pulmonary function testing for FEV1.

  • Participants who are able to demonstrate the ability to use the study inhalation device properly.

  • Male participants must be surgically sterile or agree to use highly-effective contraceptives.

  • All female participants must have a negative serum pregnancy test at Screening. Female participants of non-childbearing potential, Female participants of childbearing potential must have a negative urine pregnancy test before the administration of first dose of study intervention and must agree to use a highly-effective method of birth control.

  • Participant is a non smoker or an ex-smoker with a total smoking history of less than 10 pack-years.

  • Participant's influenza/pneumonia vaccination is up to date as per local guidelines.

  • Only for Part 1: Documented treatment with medium dose ICS with LABA for at least 6 months prior to Screening. ICS and LABA must be on a stable dose for at least 3 months prior to Screening, during Screening and Run-in Periods and may be contained in a combination product or separate inhaler. No asthma exacerbations in last 12 months requiring oral or intravenous (IV) steroids or hospitalisation/ emergency room visit due to asthma. Pre-bronchodilator FEV1 ≥ 70% predicted at Screening and start of Run-in. Asthma Control Questionnaire 6 score of ≤ 1.0 at Screening and start of Run-in.

  • Only for Part 2: Demonstration of reversibility to inhaled bronchodilators at Screening. Documented treatment with medium dose ICS-LABA for at least 12 months prior to Screening. ICS and LABA must be on a stable dose for at least 3 months prior to Screening, during Screening and Run-in Periods. If on asthma maintenance controller medications in addition to ICS-LABA, the dose of the additional controller medications must be stable for at least 3 months prior to Screening, during Screening and Run-in Periods. Have had at least one severe asthma exacerbation in the 3 years prior to Screening. Pre bronchodilator FEV1 of 60% to 80% (inclusive) predicted at Screening and start of Run-in. Blood eosinophil count of ≥ 150 cells/μL and FeNO ≥ 25 ppb at Screening. Asthma Control Questionnaire 6 score ≥ 1.5 at Screening.

Specific Randomisation Criteria at Visit 3

  • For Part 1: Pre-bronchodilator FEV1 ≥ 70% predicted. At least 70% compliance with usual asthma controller ICS-LABA during Run-in Period (from Visit 2 to Visit 3) based on daily electronic diary (e-Diary). Minimum 80% compliance with ePRO completion. Asthma Control Questionnaire 6 score of ≤ 1.0. C-reactive protein < 5 mg/L on Day -1.

  • For Part 2: Pre-bronchodilator FEV1 of 60% to 80% (inclusive) predicted. Asthma Control Questionnaire 6 score of ≥ 1.5. At least 70% compliance with usual asthma controller ICS-LABA during Run-in Period from (Visit 2 to Visit 3) based on daily e-Diary. Minimum 80% compliance with ePRO completion. C-reactive protein < 5 mg/L at Visit 2. A FeNO of ≥ 25 ppb.

Exclusion Criteria:
  • Women who are pregnant or breastfeeding, or who are planning to become pregnant during the study.

  • Known or suspected hypersensitivity including anaphylaxis/anaphylactoid reaction following any biologic therapy, or known history of drug hypersensitivity to any component of the study intervention formulation.

  • Clinically important pulmonary disease other than asthma.

  • History or clinical suspicion of any clinically relevant or active disease or disorder.

  • Diagnosis of / suspected COVID-19 infection with associated pneumonia / pneumonitis.

  • Participants with a positive test result for COVID-19.

  • History of cancer within the last 10 years, any history of lymphoma or lung cancer is strictly exclusionary.

  • Significant history of recurrent or ongoing 'dry eye'.

  • Diagnosis of Sjögren's syndrome.

  • High risk of infection suggesting abnormal immune function.

  • History of, or known significant infection or positivity at Screening period, including hepatitis B or C, human immunodeficiency virus (HIV), tuberculosis.

  • Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Screening and during Run-in.

  • Clinically significant upper respiratory tract infection at Screening and during Run-in.

  • A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained.

  • Any clinically important ECG abnormalities.

  • Any clinically significant cardiac disease.

  • Uncontrolled hypertension.

  • History of life-threatening asthma attack or asthma attack requiring ventilation.

  • Part 2 only: History of 3 or more severe asthma exacerbations.

  • Daily rescue use of SABA ≥ 8 puffs for ≥ 3 consecutive days at any time during Run-in Period, before randomisation.

  • Pre-bronchodilator FEV1 decrease or increase ≥ 20%.

  • History of anaphylaxis.

  • Any clinically significant abnormalities in haematology.

  • Alanine aminotransferase or AST level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during Screening Period.

  • History of, drug or alcohol abuse within the past 2 years prior to Screening.

  • Planned in-participant surgery, major dental procedure or hospitalisation during the study.

  • Prior/Concomitant Therapy: Systemic corticosteroid use, AZD1402, marketed or investigational biologicals such as monoclonal antibodies or chimeric biomolecules, investigational nonbiologic drug within 60 days prior to Screening and during Run-in, any immunosuppressive therapy, Live or attenuated vaccine within 4 weeks of Screening and during Run-in, Receipt of COVID-19 vaccine (vaccine or booster dose) within 30 days prior to randomisation, Immunoglobulin or blood products within 4 weeks of Screening and during Run-in, Any immunotherapy within 3 months of Screening and during Run-in.

  • Part 1 only: Additional asthma maintenance controller medications in addition to ICS-LABA (eg, leukotriene receptor inhibitors, theophylline, LAMA, chromones) within 3 months of Screening period and during Run-in.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Herston Australia 4006
2 Research Site Kent Town Australia 5067
3 Research Site Melbourne Australia IC 3004
4 Research Site Nedlands Australia 6009
5 Research Site Windsor Ontario Canada N8X 1T3
6 Research Site Berlin Germany 10119
7 Research Site Berlin Germany 10717
8 Research Site Berlin Germany 14050
9 Research Site Bonn Germany 53119
10 Research Site Frankfurt Germany 60596
11 Research Site Hamburg Germany 20354
12 Research Site Hannover Germany D-30173
13 Research Site Lübeck Germany 23552
14 Research Site Mainz Germany 55128
15 Research Site Reinfeld Germany 23858
16 Research Site Budapest Hungary 1204
17 Research Site Csorna Hungary 9300
18 Research Site Kaposvár Hungary 7400
19 Research Site Nyíregyháza Hungary 4400
20 Research Site Pécs Hungary 7635
21 Research Site Szombathely Hungary 9700
22 Research Site Cheongju-si Korea, Republic of 28644
23 Research Site Chuncheon Korea, Republic of 24289
24 Research Site Incheon Korea, Republic of 21431
25 Research Site Seoul Korea, Republic of 03312
26 Research Site Seoul Korea, Republic of 05505
27 Research Site Seoul Korea, Republic of 06591
28 Research Site Seoul Korea, Republic of 08308
29 Research Site Seoul Korea, Republic of 136-705
30 Research Site Suwon-si Korea, Republic of 16499
31 Research Site Białystok Poland 15-044
32 Research Site Krakow Poland 30-033
33 Research Site Krakow Poland 31-501
34 Research Site Kraków Poland 31-559
35 Research Site Lodz Poland 90-302
36 Research Site Lubin Poland 59-300
37 Research Site Sopot Poland 81-741
38 Research Site Wrocław Poland 53-301
39 Research Site Barcelona Spain 08916
40 Research Site Bilbao (Vizcaya) Spain 48013
41 Research Site Cádiz Spain 11009
42 Research Site Santander Spain 39008
43 Research Site Santiago de Compostela Spain 15706
44 Research Site Villarreal (Castellón) Spain 12540
45 Research Site Kiev Ukraine 02000
46 Research Site London United Kingdom SE1 9RT
47 Research Site London United Kingdom W1G 8HU

Sponsors and Collaborators

  • AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04643158
Other Study ID Numbers:
  • D2912C00003
First Posted:
Nov 24, 2020
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2022