Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (Umbriel)

May 28, 2026 updated by: AstraZeneca

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Study Overview

Status

Recruiting

Conditions

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

Phase 2

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

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - CABA, Argentina, C1425BEN
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1425
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1128
    - Withdrawn
    - Research Site
  - La Plata, Argentina, B1900
    - Recruiting
    - Research Site
  - Mendoza, Argentina, 5500
    - Recruiting
    - Research Site
  - Rosario, Argentina, 2000
    - Recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, 4000
    - Recruiting
    - Research Site
Brazil
- - Caxias do Sul, Brazil, 95070-560
    - Withdrawn
    - Research Site
  - Criciúma, Brazil, 88811-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 9061-000
    - Recruiting
    - Research Site
  - Salvador, Brazil, 40050 410
    - Withdrawn
    - Research Site
  - Santo André, Brazil, 09080-110
    - Withdrawn
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Recruiting
    - Research Site
  - São José do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05403-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04014-002
    - Recruiting
    - Research Site
Chile
- - Curicó, Chile, 3341643
    - Active, not recruiting
    - Research Site
  - Quillota, Chile, 2260000
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7500657
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7501126
    - Active, not recruiting
    - Research Site
  - Santiago, Chile, 7750495
    - Active, not recruiting
    - Research Site
  - Temuco, Chile, 4810345
    - Active, not recruiting
    - Research Site
  - Viña del Mar, Chile, 2540488
    - Active, not recruiting
    - Research Site
China
- - Baotou, China, 014010
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Recruiting
    - Research Site
  - Chengdu, China, 610000
    - Recruiting
    - Research Site
  - Chongqing, China, 400010
    - Recruiting
    - Research Site
  - Guangzhou, China, 510163
    - Recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hefei, China, 230061
    - Recruiting
    - Research Site
  - Hohhot, China, 10050
    - Recruiting
    - Research Site
  - Huizhou, China, 516001
    - Recruiting
    - Research Site
  - Qingdao, China, 266011
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200065
    - Recruiting
    - Research Site
  - Shanghai, China, 201114
    - Recruiting
    - Research Site
  - Shenzhen, China, 518020
    - Recruiting
    - Research Site
  - Wenzhou, China, 325027
    - Recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Recruiting
    - Research Site
France
- - Brest, France, 29200
    - Recruiting
    - Research Site
  - Créteil, France, 94010
    - Recruiting
    - Research Site
  - Lyon, France, 69317
    - Recruiting
    - Research Site
  - Marseille, France, 13015
    - Recruiting
    - Research Site
  - Pessac, France, 33604
    - Recruiting
    - Research Site
  - Strasbourg, France, 67091
    - Recruiting
    - Research Site
  - Suresnes, France, 92150
    - Recruiting
    - Research Site
Greece
- - Athens, Greece, 17562
    - Recruiting
    - Research Site
  - Athens, Greece, 11521
    - Recruiting
    - Research Site
  - Ioannina, Greece, 45500
    - Withdrawn
    - Research Site
  - Pátrai, Greece, 26500
    - Active, not recruiting
    - Research Site
  - Thessaloniki, Greece, 57001
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Active, not recruiting
    - Research Site
Hungary
- - Balassagyarmat, Hungary, 2660
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1121
    - Withdrawn
    - Research Site
  - Budapest, Hungary, 1036
    - Withdrawn
    - Research Site
  - Debrecen, Hungary, 4032
    - Recruiting
    - Research Site
  - Gödöllő, Hungary, 2100
    - Recruiting
    - Research Site
  - Pécs, Hungary, 7635
    - Recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Recruiting
    - Research Site
India
- - Belagavi, India, 590010
    - Recruiting
    - Research Site
  - Coimbatore, India, 641028
    - Recruiting
    - Research Site
  - Dehradun, India, 248001
    - Recruiting
    - Research Site
  - Delhi, India, 110029
    - Recruiting
    - Research Site
  - Faridabad, India, 121012
    - Withdrawn
    - Research Site
  - Gurgaon, India, 122001
    - Recruiting
    - Research Site
  - Kochi, India, 682027
    - Recruiting
    - Research Site
  - Lucknow, India, 226003
    - Suspended
    - Research Site
  - New Delhi, India, 110005
    - Recruiting
    - Research Site
  - Vadodara, India, 391760
    - Recruiting
    - Research Site
Israel
- - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91120
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 44281
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Rehovot, Israel, 76100
    - Not yet recruiting
    - Research Site
Italy
- - Catania, Italy, 95123
    - Recruiting
    - Research Site
  - Foggia, Italy, 71100
    - Recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Recruiting
    - Research Site
  - Roma, Italy, 00168
    - Recruiting
    - Research Site
Japan
- - Fukuoka, Japan, 811-1394
    - Recruiting
    - Research Site
  - Ginowan-shi, Japan, 901-2214
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 730-0013
    - Recruiting
    - Research Site
  - Ishinomaki, Japan, 986-8522
    - Recruiting
    - Research Site
  - Kawaguchi-shi, Japan, 332-8558
    - Recruiting
    - Research Site
  - Kiyose-shi, Japan, 204-8585
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0017
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 152-8902
    - Recruiting
    - Research Site
  - Miura, Japan, 238-0111
    - Recruiting
    - Research Site
  - Neyagawa, Japan, 572-8551
    - Recruiting
    - Research Site
  - Sapporo, Japan, 064-0804
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-0033
    - Recruiting
    - Research Site
  - Takamatsu, Japan, 761-8073
    - Recruiting
    - Research Site
  - Ube, Japan, 755-8505
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0066
    - Recruiting
    - Research Site
  - Yokohama, Japan, 245-8575
    - Recruiting
    - Research Site
  - Yokohama, Japan, 232-0024
    - Recruiting
    - Research Site
Peru
- - Lima, Peru, 15088
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 1
    - Recruiting
    - Research Site
  - Lima, Peru, 15082
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 21
    - Withdrawn
    - Research Site
  - Lima, Peru, LIMA 33
    - Suspended
    - Research Site
Philippines
- - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Las Piñas, Philippines, 1742
    - Withdrawn
    - Research Site
  - Lipa City, Philippines, 4217
    - Recruiting
    - Research Site
  - Manadaluyong City, Philippines, 1552
    - Recruiting
    - Research Site
  - Quezon City, Philippines, 1100
    - Recruiting
    - Research Site
  - Roxas City, Philippines, 5800
    - Withdrawn
    - Research Site
South Africa
- - Bellville, South Africa, 7530
    - Recruiting
    - Research Site
  - Benoni, South Africa, 1501
    - Recruiting
    - Research Site
  - Brackenfell, South Africa, 7560
    - Recruiting
    - Research Site
  - Cape Town, South Africa, 7700
    - Recruiting
    - Research Site
  - Durban, South Africa, 4093
    - Recruiting
    - Research Site
  - Somerset West, South Africa, 7130
    - Recruiting
    - Research Site
  - eMkhomazi, South Africa, 4170
    - Recruiting
    - Research Site
South Korea
- - Cheongju-si, South Korea, 28644
    - Recruiting
    - Research Site
  - Daegu, South Korea, 42415
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03312
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Seoul, South Korea, 08308
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08003
    - Recruiting
    - Research Site
  - Barcelona, Spain, 8025
    - Recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Mérida, Spain, 06800
    - Withdrawn
    - Research Site
  - Patraix, Spain, 46017
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 231
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 433004
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11220
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 110
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11696
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chanthaburi, Thailand, 22000
    - Recruiting
    - Research Site
  - Chiang Rai, Thailand, 57000
    - Recruiting
    - Research Site
  - Chon Buri, Thailand, 20000
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Nakhon Sri Thammarat, Thailand, 80000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01330
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06280
    - Recruiting
    - Research Site
  - Bursa, Turkey (Türkiye), 16059
    - Recruiting
    - Research Site
  - Gaziantep, Turkey (Türkiye), 27470
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34890
    - Recruiting
    - Research Site
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Research Site
  - Mersin, Turkey (Türkiye), 33079
    - Recruiting
    - Research Site
United States
- California
  - Bakersfield, California, United States, 93301
    - Recruiting
    - Research Site
  - Huntington Beach, California, United States, 92647
    - Withdrawn
    - Research Site
  - La Mesa, California, United States, 91942
    - Terminated
    - Research Site
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Research Site
  - San Jose, California, United States, 95117
    - Recruiting
    - Research Site
- Delaware
  - Wilmington, Delaware, United States, 19805
    - Terminated
    - Research Site
- Florida
  - Cutler Bay, Florida, United States, 33189
    - Suspended
    - Research Site
  - Hialeah, Florida, United States, 33012
    - Suspended
    - Research Site
  - Hialeah, Florida, United States, 33015
    - Suspended
    - Research Site
  - Leesburg, Florida, United States, 34748
    - Withdrawn
    - Research Site
  - Miami, Florida, United States, 33175
    - Suspended
    - Research Site
  - Miami, Florida, United States, 33155
    - Suspended
    - Research Site
  - Orlando, Florida, United States, 32819
    - Suspended
    - Research Site
  - Palmetto Bay, Florida, United States, 33157
    - Suspended
    - Research Site
  - Tampa, Florida, United States, 33607
    - Suspended
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Suspended
    - Research Site
- Idaho
  - Boise, Idaho, United States, 83706
    - Withdrawn
    - Research Site
- Indiana
  - Noblesville, Indiana, United States, 46060
    - Recruiting
    - Research Site
- Iowa
  - West Des Moines, Iowa, United States, 50266
    - Recruiting
    - Research Site
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - Not yet recruiting
    - Research Site
  - Kansas City, Kansas, United States, 66160
    - Not yet recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40218
    - Recruiting
    - Research Site
- Maryland
  - White Marsh, Maryland, United States, 21162
    - Withdrawn
    - Research Site
- Michigan
  - Farmington Hills, Michigan, United States, 48336
    - Recruiting
    - Research Site
  - Warren, Michigan, United States, 48088
    - Withdrawn
    - Research Site
- Missouri
  - St Louis, Missouri, United States, 63141
    - Withdrawn
    - Research Site
- Nebraska
  - Bellevue, Nebraska, United States, 68123
    - Withdrawn
    - Research Site
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Research Site
  - Omaha, Nebraska, United States, 68134
    - Recruiting
    - Research Site
- New Jersey
  - Toms River, New Jersey, United States, 08755
    - Recruiting
    - Research Site
- New York
  - Maspeth, New York, United States, 11378
    - Recruiting
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Withdrawn
    - Research Site
  - Huntersville, North Carolina, United States, 28078
    - Withdrawn
    - Research Site
  - Kings Mountain, North Carolina, United States, 28086
    - Recruiting
    - Research Site
  - Pinehurst, North Carolina, United States, 28374
    - Not yet recruiting
    - Research Site
- Ohio
  - Toledo, Ohio, United States, 43617
    - Recruiting
    - Research Site
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Withdrawn
    - Research Site
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Withdrawn
    - Research Site
  - Medford, Oregon, United States, 97504
    - Recruiting
    - Research Site
  - Portland, Oregon, United States, 97202
    - Recruiting
    - Research Site
- Pennsylvania
  - DuBois, Pennsylvania, United States, 15801
    - Terminated
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Research Site
  - Smithfield, Pennsylvania, United States, 15478
    - Recruiting
    - Research Site
- South Carolina
  - Rock Hill, South Carolina, United States, 29732
    - Recruiting
    - Research Site
- Tennessee
  - Knoxville, Tennessee, United States, 37919
    - Terminated
    - Research Site
- Texas
  - Austin, Texas, United States, 78759
    - Recruiting
    - Research Site
  - Forney, Texas, United States, 75126
    - Terminated
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - Research Site
  - Sugar Land, Texas, United States, 77478
    - Not yet recruiting
    - Research Site
  - Tyler, Texas, United States, 75708
    - Withdrawn
    - Research Site
  - Victoria, Texas, United States, 77901
    - Recruiting
    - Research Site
- Utah
  - Roy, Utah, United States, 84067
    - Terminated
    - Research Site
- Washington
  - Bellingham, Washington, United States, 98225
    - Terminated
    - Research Site
- West Virginia
  - Kingwood, West Virginia, United States, 26537
    - Recruiting
    - Research Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53228
    - Recruiting
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Haiphong, Vietnam, 180000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Ho Chi Minh City, Vietnam, 10000
    - Recruiting
    - Research Site
  - Huế, Vietnam, 530000
    - Recruiting
    - 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

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Provision of signed and dated written informed consent prior to any study-specific procedures.
Adults aged 18-75, inclusive when signing the informed consent.
Documented physician-diagnosis of asthma for at least 12 months.
Treated with medium or high dose ICS in combination with LABA.
Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
Documented exacerbation history in the last 12 months and biomarker requirements of:
1. 2 severe exacerbations OR
2. 1 severe exacerbation and:
(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
Clinically significant pulmonary disease other than asthma .
Current smokers, former smokers with >10 pack-years history.
Clinically significant aortic stenosis or pulmonary arterial hypertension.
Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
Unstable cardiovascular disorders.

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: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Dosing subcutaneously with equivalent volume to tozorakimab	Drug: Placebo Placebo will be administered subcutaneously.
Experimental: Tozorakimab Dose 1 Dosing subcutaneously tozorakimab Dose 1	Drug: Tozorakimab The drug will be administered subcutaneously.
Experimental: Tozorakimab Dose 2 Dosing subcutaneously tozorakimab Dose 2 and placebo	Drug: Tozorakimab The drug will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualised rate of severe asthma exacerbations Time Frame: Over 26 to 52 weeks	The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.	Over 26 to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough serum concentrations of tozorakimab Time Frame: Over 52 weeks	Pharmacokinetics: concentrations of tozorakimab in trough serum.	Over 52 weeks
Annualised rate of severe asthma exacerbations Time Frame: Over 26 to 52 weeks	The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and baseline eosinophils < 300 cells/µL and history of ≥2 severe exacerbations within 12 months prior to screening.	Over 26 to 52 weeks
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) Time Frame: Over weeks 20 to 26	Difference in mean change from baseline between tozorakimab and placebo.	Over weeks 20 to 26
Change from baseline in post-bronchodilator FEV1 Time Frame: At week 26	Difference in mean change from baseline between tozorakimab and placebo.	At week 26
Anti-drug antibody incidence Time Frame: Over 52 weeks	Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab	Over 52 weeks
Time to first severe asthma exacerbation Time Frame: Over 26 to 52 weeks	To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations.	Over 26 to 52 weeks
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6) Time Frame: At week 26	Difference in mean change from baseline between tozorakimab and placebo. The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease.	At week 26
Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+) Time Frame: At week 26	Difference in mean change from baseline between tozorakimab and placebo. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains.	At week 26

Collaborators and Investigators

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

Sponsor

AstraZeneca

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)

March 26, 2025

Primary Completion (Estimated)

June 24, 2027

Study Completion (Estimated)

March 16, 2028

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D9181C00002
2024-519116-14-00 (Registry Identifier: CTIS)

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 shared.

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 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 anonymized individual patient-level data via secure research environment Vivli.org.

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

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

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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Withdrawn

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Asthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; Status

United States
University of California, San Francisco

Completed

User-Friendly Spirometer and Mobile App for Self-Management and Home Monitoring of Asthma Patients

Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic

United States
Columbia University
Children's Hospital of Philadelphia; National Heart, Lung, and Blood Institute... and other collaborators

Not yet recruiting

Bilevel Positive Airway Pressure (BPAP) for Severe Asthma

Acute Asthma | Pediatric Asthma | Non-invasive Positive Pressure Ventilation | BiPAP

United States
SingHealth Polyclinics

Recruiting

Remote Patient Monitoring Solution for Chronic Respiratory Disease Management

Asthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic

Singapore
Johann Wolfgang Goethe University Hospital

Completed

Exercise Challenge in a Cold Chamber

Exercise-induced Asthma

Germany
Chiesi Slovenija, d.o.o.

Recruiting

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH) (STRENGTH)

Asthma | Asthma Bronchiale | Asthma Patients

Slovenia
Gümüşhane Universıty

Completed

Effects of Inspiratory Muscle Training Added to a Swimming Program in Children With Asthma (IMT-SWIM-ASTHM)

Asthma | Asthma Chronic | Asthma Control

Turkey (Türkiye)
Parc de Salut Mar

Active, not recruiting

Asthma Research in Children and Adolescents (ARCA)

Asthma in Children | Persistent Asthma | Asthma Exacerbation

Spain

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States

Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (Umbriel)

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

Study Overview

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