A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma (HORIZON)

August 14, 2026 updated by: AstraZeneca

A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase-3 multicentre, double-blind, parallel-group placebo-controlled, randomised study.

The study will comprise of:

  1. Screening/Run-in period of 4 to 6 weeks,
  2. 52-week double-blind Treatment period,
  3. Post-treatment Follow-up period of 12 weeks.

Participants will be randomised 2:1 to receive either tezepelumab or placebo administered by (SC) Subcutaneous injections for 52 weeks (double-blind Treatment period).

There will then be a 12-week off-treatment Follow-up period for participants who do not continue in the optional open-label Active Treatment Extension period.

An optional open-label Active Treatment Extension will allow all eligible participants the opportunity to receive active treatment with tezepelumab. The Active Treatment Extension period of the study will start following the 52-week double-blind Treatment period and will consist of a 104-week open-label Treatment period prior to the 12-week post-treatment Follow-up period.

Study Type

Interventional

Enrollment (Estimated)

231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Recruiting
        • Research Site
      • Buenos Aires, Argentina, C1121ABE
        • Recruiting
        • Research Site
      • Buenos Aires, Argentina, C1122
        • Recruiting
        • Research Site
      • CABA, Argentina, C1028AAP
        • Terminated
        • Research Site
      • Florida, Argentina, B1602DQD
        • Recruiting
        • Research Site
      • Lanus, Argentina, B1824KAJ
        • Recruiting
        • Research Site
      • Lobos, Argentina, 7240
        • Recruiting
        • Research Site
      • Mendoza, Argentina, M5500CCG
        • Recruiting
        • Research Site
      • Quilmes, Argentina, B1878FNR
        • Terminated
        • Research Site
      • Rosario, Argentina, 2000
        • Recruiting
        • Research Site
  • Brazil
      • Blumenau, Brazil, 89030-101
        • Recruiting
        • Research Site
      • Curitiba, Brazil, 80060-240
        • Recruiting
        • Research Site
      • Salvador, Brazil, 40060-330
        • Withdrawn
        • Research Site
      • Sorocaba, Brazil, 18040-425
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 04024-002
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01227-200
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 05430-010
        • Recruiting
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Recruiting
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Recruiting
        • Research Site
      • Hamilton, Ontario, Canada, L8S 1G5
        • Recruiting
        • Research Site
      • Windsor, Ontario, Canada, N8X 2G1
        • Recruiting
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Research Site
  • China
      • Beijing, China, 100191
        • Recruiting
        • Research Site
      • Changchun, China, 130021
        • Recruiting
        • Research Site
      • Hohhot, China, 010050
        • Not yet recruiting
        • Research Site
      • Lanzhou, China, 730000
        • Recruiting
        • Research Site
      • Nanjing, China, 210008
        • Recruiting
        • Research Site
      • Shanghai, China, 200127
        • Withdrawn
        • Research Site
      • Shanghai, China, 200062
        • Recruiting
        • Research Site
      • Shenyang, China, 110004
        • Recruiting
        • Research Site
      • Shenzhen, China, 518026
        • Recruiting
        • Research Site
      • Tianjin, China, 300201
        • Not yet recruiting
        • Research Site
      • Wuxi, China, 214023
        • Recruiting
        • Research Site
      • Zhanjiang, China, 524001
        • Not yet recruiting
        • Research Site
      • Zhongshan, China, 528400
        • Not yet recruiting
        • Research Site
  • Colombia
      • Bogotá, Colombia, 110231
        • Withdrawn
        • Research Site
      • Bogotá, Colombia
        • Withdrawn
        • Research Site
      • Medellín, Colombia, 050034
        • Withdrawn
        • Research Site
  • France
      • Brest, France, 29609
        • Recruiting
        • Research Site
      • Bron, France, 69500
        • Suspended
        • Research Site
      • Créteil, France, 94010
        • Recruiting
        • Research Site
      • Marseille, France, 13005
        • Recruiting
        • Research Site
      • Paris, France, 75012
        • Recruiting
        • Research Site
      • Paris, France, 75015
        • Recruiting
        • Research Site
      • Paris, France, 75019
        • Recruiting
        • Research Site
      • Rouen, France, 76031
        • Recruiting
        • Research Site
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Research Site
  • Hungary
      • Debrecen, Hungary, 4031
        • Recruiting
        • Research Site
      • Szeged, Hungary, 6720
        • Recruiting
        • Research Site
      • Szigetvár, Hungary, 7900
        • Recruiting
        • Research Site
  • Italy
      • Genova, Italy, 16147
        • Recruiting
        • Research Site
      • Pavia, Italy, 27100
        • Recruiting
        • Research Site
      • Roma, Italy, 00165
        • Not yet recruiting
        • Research Site
  • Japan
      • Fukuoka, Japan, 811-1394
        • Recruiting
        • Research Site
      • Fukuoka, Japan, 813-0017
        • Recruiting
        • Research Site
      • Fukuyama, Japan, 720-8520
        • Recruiting
        • Research Site
      • Funabashi-shi, Japan, 273-8588
        • Recruiting
        • Research Site
      • Nara, Japan, 630-8581
        • Recruiting
        • Research Site
      • Odawara, Japan, 250-0055
        • Recruiting
        • Research Site
      • Saga, Japan, 840-8571
        • Recruiting
        • Research Site
      • Shimotsuga-gun, Japan, 321-0293
        • Recruiting
        • Research Site
      • Yokohama, Japan, 223-0059
        • Withdrawn
        • Research Site
      • Ōtsu, Japan, 520-0804
        • Recruiting
        • Research Site
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Research Site
      • Guadalajara, Mexico, 44100
        • Recruiting
        • Research Site
      • Mexico City, Mexico, 06100
        • Not yet recruiting
        • Research Site
      • Veracruz, Mexico, 91910
        • Recruiting
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Research Site
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Research Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Recruiting
        • Research Site
      • Las Piñas, Philippines, 1740
        • Recruiting
        • Research Site
      • Quezon, Philippines, 1100
        • Recruiting
        • Research Site
      • Santa Rosa, Philippines, 4026
        • Recruiting
        • Research Site
  • Poland
      • Lodz, Poland, 90-329
        • Recruiting
        • Research Site
      • Tarnów, Poland, 33-100
        • Recruiting
        • Research Site
  • Romania
      • Bucharest, Romania, 050159
        • Recruiting
        • Research Site
      • Bucharest, Romania, 020395
        • Recruiting
        • Research Site
  • South Africa
      • Bellville, South Africa, 7531
        • Recruiting
        • Research Site
      • Cape Town, South Africa, 7925
        • Recruiting
        • Research Site
      • Durban, South Africa, 4001
        • Recruiting
        • Research Site
      • Durban, South Africa, 3630
        • Recruiting
        • Research Site
      • Middelburg, South Africa, 1055
        • Recruiting
        • Research Site
      • Thabazimbi, South Africa, 0380
        • Withdrawn
        • Research Site
      • Vereeniging, South Africa, 1935
        • Recruiting
        • Research Site
      • Welkom, South Africa, 9460
        • Recruiting
        • Research Site
  • South Korea
      • Seongnam-si, South Korea, 13620
        • Recruiting
        • Research Site
      • Seongnam-si, South Korea, 13496
        • Withdrawn
        • Research Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03181
        • Recruiting
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Research Site
      • Esplugues de Llobregat (Barc), Spain, 08950
        • Recruiting
        • Research Site
      • Madrid, Spain, 28009
        • Recruiting
        • Research Site
      • Sabadell, Spain, 08208
        • Recruiting
        • Research Site
      • Valencia, Spain, 46010
        • Recruiting
        • Research Site
      • Valencia, Spain, 46026
        • Withdrawn
        • Research Site
      • Villarreal, Spain, 12540
        • Recruiting
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Research Site
      • Bangkoknoi, Thailand, 10700
        • Recruiting
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Research Site
      • Muang, Thailand, 40002
        • Recruiting
        • Research Site
  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye), 16059
        • Recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34899
        • Recruiting
        • Research Site
      • Izmir, Turkey (Türkiye), 35210
        • Recruiting
        • Research Site
      • Yenimahalle, Turkey (Türkiye), 06500
        • Recruiting
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine, 58002
        • Recruiting
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76000
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 04050
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 03038
        • Recruiting
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Recruiting
        • Research Site
      • Bradford, United Kingdom, BD9 6RJ
        • Recruiting
        • Research Site
      • Bristol, United Kingdom, BS2 8BJ
        • Recruiting
        • Research Site
      • Glasgow, United Kingdom, G3 8SJ
        • Withdrawn
        • Research Site
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Research Site
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Research Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • Research Site
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36106
        • Recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Withdrawn
        • Research Site
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Research Site
      • Long Beach, California, United States, 90806
        • Recruiting
        • Research Site
      • Orange, California, United States, 92868
        • Withdrawn
        • Research Site
      • San Diego, California, United States, 92123
        • Recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Terminated
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Terminated
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Research Site
    • New Jersey
      • Northfield, New Jersey, United States, 08225
        • Recruiting
        • Research Site
    • New York
      • Hawthorne, New York, United States, 10532
        • Recruiting
        • Research Site
      • Schenectady, New York, United States, 12304
        • Withdrawn
        • Research Site
      • Staten Island, New York, United States, 10305
        • Recruiting
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Research Site
      • Toledo, Ohio, United States, 43617
        • Recruiting
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Withdrawn
        • Research Site
    • Texas
      • Coppell, Texas, United States, 75019
        • Terminated
        • Research Site
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Research Site
      • Frisco, Texas, United States, 75034
        • Withdrawn
        • Research Site
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Research Site
      • San Antonio, Texas, United States, 78249
        • Recruiting
        • Research Site
      • Temple, Texas, United States, 76508
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
  2. Participants must be 5 to < 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.
  3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
  4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
  5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.

  6. Supportive evidence of asthma as documented by one of the following:

    1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.

      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:

    2. Post-BD responsiveness of FEV1 ≥ 10%.
    3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
    4. PEF average daily diurnal variability > 13% over a 2-week period.
    5. Variability of FEV1 ≥ 12% between any two clinical visits.
    6. Positive exercise challenge test (defined as a fall in FEV1 of > 12%).
    7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
  7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.
  8. Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.

  9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:

    1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.
    2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.
    3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
    4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.
  10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion Criteria:

  1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
  2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
  4. Change in ICS dose within 1 month prior to Visit 1.
  5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tezepelumab
Participants will be receiving tezepelumab subcutaneous injection
Biological: Tezepelumab
Participants will be receiving subcutaneous injection of tezepelumab
Other Names:
  • MEDI9929 and AMG157
Placebo Comparator: Placebo
Participants will be receiving placebo through a subcutaneous injection
Other: Placebo
Participants will be receiving subcutaneous injection of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized severe asthma exacerbation rate (AAER)
Time Frame: From Baseline to Week 52
To assess the effect of tezepelumab on severe asthma exacerbations in children 5 to < 12 years old with severe uncontrolled asthma compared with placebo.
From Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)
Time Frame: From Baseline to Week 52
To assess the effect of tezepelumab on pulmonary function (FEV1) in children with severe uncontrolled asthma compared with placebo. Pre-bronchodilator FEV1% PN will be determined by spirometry at the clinic visit.
From Baseline to Week 52
AAER associated with allergic asthma
Time Frame: From Baseline to Week 52
AAER will be assessed in association with both allergic asthma (defined by a positive perennial allergen using serum specific IgE [FEIA]).
From Baseline to Week 52
Time to first severe asthma exacerbation
Time Frame: From Baseline to Week 52
Time to first severe asthma exacerbation will be assessed.
From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation
Time Frame: From Baseline to Week 52
Proportion of participants with ≥ 1 severe asthma exacerbation will be assessed.
From Baseline to Week 52
AAER associated with ER visit or hospitalisation
Time Frame: From Baseline to Week 52
AAER will be assessed in association with ER visits or hospitalisations.
From Baseline to Week 52
Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score
Time Frame: From Baseline to Week 52
Change from baseline in PASO score will be assessed. The PASO questionnaire will be completed by the caregiver each day from the evening of Treatment period. Caregivers in this study will complete 4 items from the morning assessment capturing night-time asthma symptoms, rescue medication use, night-time awakenings, and maintenance asthma medication use. The evening assessment will capture daytime asthma symptoms, rescue medication use, activity limitation and change in asthma.
From Baseline to Week 52
Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score
Time Frame: From Baseline to Week 52
Change from baseline in ACQ-IA score will be assessed. The ACQ-IA will only be completed for participants ≥ 6 years old at Screening. The ACQ-IA is administered by trained individuals according to standardised instructions to help the child understand concepts like symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of SABA during the past week using a 7-point scale. The ACQ-IA score is calculated by taking the mean of the 6 equally weighted items and ranges from 0 (well controlled) to 6 (extremely poorly controlled). The estimated minimal clinically important difference is 0.5
From Baseline to Week 52
Change from baseline in weekly mean rescue medication use
Time Frame: From Baseline to Week 52
Change from baseline in weekly mean rescue medication use will be assessed.
From Baseline to Week 52
Change from baseline in weekly mean number of night-time awakenings
Time Frame: From Baseline to Week 52
Change from baseline in weekly mean number of night-time awakenings will be assessed.
From Baseline to Week 52
Change from baseline in blood eosinophil count
Time Frame: From Baseline to Week 52
Change from baseline in blood eosinophil count will be assessed.
From Baseline to Week 52
Change from baseline in fractional exhaled nitric oxide (FeNO)
Time Frame: From Baseline to Week 52
Change from baseline in FeNO will be assessed.
From Baseline to Week 52
Change from baseline in total serum IgE
Time Frame: From Baseline to Week 52
Change from baseline in total serum IgE will be assessed.
From Baseline to Week 52
Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF)
Time Frame: From Baseline to Week 52
The effect of tezepelumab on pulmonary function compared with placebo will be assessed using spirometry.
From Baseline to Week 52
Number of asthma--related healthcare resource utilization (HRU)
Time Frame: From Baseline to Week 52
Mean number and type of Asthma specific HRU (eg, unscheduled physician visits, unscheduled phone calls to physicians, use of other asthma medications) will be assessed.
From Baseline to Week 52
Number of participant/caregiver health-related absences
Time Frame: From Baseline to Week 52
Mean number of participant/caregiver health-related absences from work/school due to asthma will be assessed.
From Baseline to Week 52
Serum concentrations of tezepelumab
Time Frame: At Baseline, Week 4, Week 24, and Week 52
To evaluate the pharmacokinetics of tezepelumab.
At Baseline, Week 4, Week 24, and Week 52
Incidence of anti-drug antibodies (ADAs)
Time Frame: At Baseline, and from time of first dose at Week 0 to end of study at week 64
To evaluate the immunogenicity of tezepelumab.
At Baseline, and from time of first dose at Week 0 to end of study at week 64
Incidence of neutralising antibodies (nAbs)
Time Frame: At Baseline, and from time of first dose at Week 0 to end of study at week 64
To evaluate the immunogenicity of tezepelumab.
At Baseline, and from time of first dose at Week 0 to end of study at week 64
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations
Time Frame: From Baseline to Week 52
Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations over the 52 week double-blind treatment period
From Baseline to Week 52
Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score
Time Frame: From Baseline to Week 52
Change from baseline of PAQLQ-(S)-IA total score will be assessed. The PAQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with asthma. The PAQLQ-(S)-IA has 23 questions in 3 domains (symptoms, activity limitation, and emotional function). Participants are asked to think about how they have been during the previous week and respond to each question on a 7-point scale (1 = extremely bothered to 7 = not bothered at all or 1 = all of the time to 7 = none of the time). There are 2 coloured cards (green and blue), which list sets of response options appropriate to different questions. The appropriate card should be used by the participant during completion of each question and then taken back when it is no longer required. The overall PAQLQ-(S)-IA score is the mean of all 23 responses, and the individual domain scores are the means of the items in those domains.
From Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

August 23, 2030

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5180C00016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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