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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519116-14-00 | Registry Identifier | CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tozorakimab Dose 1 | Experimental | Dosing subcutaneously tozorakimab Dose 1 |
|
| Tozorakimab Dose 2 | Experimental | Dosing subcutaneously tozorakimab Dose 2 and placebo |
|
| Placebo | Placebo Comparator | Dosing subcutaneously with equivalent volume to tozorakimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tozorakimab | Drug | The drug will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualised rate of severe asthma exacerbations | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualised rate of severe asthma exacerbations | 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 |
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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:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Bakersfield | California | 93301 | United States | |
| Research Site |
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.
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.
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.
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This is a parallel-group treatment study with 3 arms. Participants will be randomised in a ratio of 1:1:1 to one of the 3 treatment arms.
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| Placebo | Drug | Placebo will be administered subcutaneously. |
|
| Time to first severe asthma exacerbation |
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 pre-bronchodilator forced expiratory volume in 1 second (FEV1) | Difference in mean change from baseline between tozorakimab and placebo. | Over weeks 20 to 26 |
| Change from baseline in post-bronchodilator FEV1 | Difference in mean change from baseline between tozorakimab and placebo. | At week 26 |
| Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6) | 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+) | 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 |
| Trough serum concentrations of tozorakimab | Pharmacokinetics: concentrations of tozorakimab in trough serum. | Over 52 weeks |
| Anti-drug antibody incidence | Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab | Over 52 weeks |
| Withdrawn |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Research Site | Terminated | La Mesa | California | 91942 | United States |
| Research Site | Recruiting | Newport Beach | California | 92663 | United States |
| Research Site | Recruiting | San Jose | California | 95117 | United States |
| Research Site | Terminated | Wilmington | Delaware | 19805 | United States |
| Research Site | Suspended | Cutler Bay | Florida | 33189 | United States |
| Research Site | Suspended | Hialeah | Florida | 33012 | United States |
| Research Site | Suspended | Hialeah | Florida | 33015 | United States |
| Research Site | Withdrawn | Leesburg | Florida | 34748 | United States |
| Research Site | Suspended | Miami | Florida | 33155 | United States |
| Research Site | Suspended | Miami | Florida | 33175 | United States |
| Research Site | Suspended | Orlando | Florida | 32819 | United States |
| Research Site | Suspended | Palmetto Bay | Florida | 33157 | United States |
| Research Site | Suspended | Tampa | Florida | 33607 | United States |
| Research Site | Suspended | Winter Park | Florida | 32789 | United States |
| Research Site | Withdrawn | Boise | Idaho | 83706 | United States |
| Research Site | Recruiting | Noblesville | Indiana | 46060 | United States |
| Research Site | Recruiting | West Des Moines | Iowa | 50266 | United States |
| Research Site | Not yet recruiting | Hutchinson | Kansas | 67502 | United States |
| Research Site | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
| Research Site | Recruiting | Louisville | Kentucky | 40218 | United States |
| Research Site | Withdrawn | White Marsh | Maryland | 21162 | United States |
| Research Site | Recruiting | Farmington Hills | Michigan | 48336 | United States |
| Research Site | Withdrawn | Warren | Michigan | 48088 | United States |
| Research Site | Withdrawn | St Louis | Missouri | 63141 | United States |
| Research Site | Withdrawn | Bellevue | Nebraska | 68123 | United States |
| Research Site | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Research Site | Recruiting | Omaha | Nebraska | 68134 | United States |
| Research Site | Recruiting | Toms River | New Jersey | 08755 | United States |
| Research Site | Recruiting | Maspeth | New York | 11378 | United States |
| Research Site | Withdrawn | Asheville | North Carolina | 28803 | United States |
| Research Site | Withdrawn | Huntersville | North Carolina | 28078 | United States |
| Research Site | Recruiting | Kings Mountain | North Carolina | 28086 | United States |
| Research Site | Not yet recruiting | Pinehurst | North Carolina | 28374 | United States |
| Research Site | Recruiting | Toledo | Ohio | 43617 | United States |
| Research Site | Withdrawn | Edmond | Oklahoma | 73034 | United States |
| Research Site | Withdrawn | Grants Pass | Oregon | 97527 | United States |
| Research Site | Recruiting | Medford | Oregon | 97504 | United States |
| Research Site | Recruiting | Portland | Oregon | 97202 | United States |
| Research Site | Terminated | DuBois | Pennsylvania | 15801 | United States |
| Research Site | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Recruiting | Smithfield | Pennsylvania | 15478 | United States |
| Research Site | Recruiting | Rock Hill | South Carolina | 29732 | United States |
| Research Site | Terminated | Knoxville | Tennessee | 37919 | United States |
| Research Site | Recruiting | Austin | Texas | 78759 | United States |
| Research Site | Terminated | Forney | Texas | 75126 | United States |
| Research Site | Recruiting | Kingwood | Texas | 77339 | United States |
| Research Site | Not yet recruiting | Sugar Land | Texas | 77478 | United States |
| Research Site | Withdrawn | Tyler | Texas | 75708 | United States |
| Research Site | Recruiting | Victoria | Texas | 77901 | United States |
| Research Site | Terminated | Roy | Utah | 84067 | United States |
| Research Site | Terminated | Bellingham | Washington | 98225 | United States |
| Research Site | Recruiting | Kingwood | West Virginia | 26537 | United States |
| Research Site | Recruiting | Milwaukee | Wisconsin | 53228 | United States |
| Research Site | Recruiting | CABA | C1425BEN | Argentina |
| Research Site | Withdrawn | Ciudad de Buenos Aires | 1128 | Argentina |
| Research Site | Recruiting | Ciudad de Buenos Aires | 1425 | Argentina |
| Research Site | Recruiting | La Plata | B1900 | Argentina |
| Research Site | Recruiting | Mendoza | 5500 | Argentina |
| Research Site | Recruiting | Rosario | 2000 | Argentina |
| Research Site | Recruiting | San Miguel de Tucumán | 4000 | Argentina |
| Research Site | Withdrawn | Caxias do Sul | 95070-560 | Brazil |
| Research Site | Recruiting | Criciúma | 88811-000 | Brazil |
| Research Site | Recruiting | Porto Alegre | 9061-000 | Brazil |
| Research Site | Recruiting | Porto Alegre | 91350-200 | Brazil |
| Research Site | Withdrawn | Salvador | 40050 410 | Brazil |
| Research Site | Withdrawn | Santo André | 09080-110 | Brazil |
| Research Site | Recruiting | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | Recruiting | São Paulo | 04014-002 | Brazil |
| Research Site | Recruiting | São Paulo | 05403-000 | Brazil |
| Research Site | Recruiting | Sorocaba | 18040-425 | Brazil |
| Research Site | Active, not recruiting | Curicó | 3341643 | Chile |
| Research Site | Active, not recruiting | Quillota | 2260000 | Chile |
| Research Site | Active, not recruiting | Santiago | 7500657 | Chile |
| Research Site | Active, not recruiting | Santiago | 7501126 | Chile |
| Research Site | Active, not recruiting | Santiago | 7750495 | Chile |
| Research Site | Active, not recruiting | Temuco | 4810345 | Chile |
| Research Site | Active, not recruiting | Viña del Mar | 2540488 | Chile |
| Research Site | Recruiting | Baotou | 014010 | China |
| Research Site | Recruiting | Changchun | 130021 | China |
| Research Site | Recruiting | Chengdu | 610000 | China |
| Research Site | Recruiting | Chongqing | 400010 | China |
| Research Site | Recruiting | Guangzhou | 510163 | China |
| Research Site | Recruiting | Haikou | 570311 | China |
| Research Site | Recruiting | Hefei | 230061 | China |
| Research Site | Recruiting | Hohhot | 10050 | China |
| Research Site | Recruiting | Huizhou | 516001 | China |
| Research Site | Recruiting | Qingdao | 266011 | China |
| Research Site | Recruiting | Shanghai | 200025 | China |
| Research Site | Recruiting | Shanghai | 200065 | China |
| Research Site | Recruiting | Shanghai | 201114 | China |
| Research Site | Recruiting | Shenzhen | 518020 | China |
| Research Site | Recruiting | Wenzhou | 325027 | China |
| Research Site | Recruiting | Xuzhou | 221000 | China |
| Research Site | Recruiting | Brest | 29200 | France |
| Research Site | Recruiting | Créteil | 94010 | France |
| Research Site | Recruiting | Lyon | 69317 | France |
| Research Site | Recruiting | Marseille | 13015 | France |
| Research Site | Recruiting | Pessac | 33604 | France |
| Research Site | Recruiting | Strasbourg | 67091 | France |
| Research Site | Recruiting | Suresnes | 92150 | France |
| Research Site | Recruiting | Athens | 11521 | Greece |
| Research Site | Recruiting | Athens | 17562 | Greece |
| Research Site | Withdrawn | Ioannina | 45500 | Greece |
| Research Site | Active, not recruiting | Pátrai | 26500 | Greece |
| Research Site | Recruiting | Thessaloniki | 57001 | Greece |
| Research Site | Active, not recruiting | Thessaloniki | 57010 | Greece |
| Research Site | Recruiting | Balassagyarmat | 2660 | Hungary |
| Research Site | Withdrawn | Budapest | 1036 | Hungary |
| Research Site | Withdrawn | Budapest | 1121 | Hungary |
| Research Site | Recruiting | Debrecen | 4032 | Hungary |
| Research Site | Recruiting | Gödöllő | 2100 | Hungary |
| Research Site | Recruiting | Pécs | 7635 | Hungary |
| Research Site | Recruiting | Törökbálint | 2045 | Hungary |
| Research Site | Recruiting | Belagavi | 590010 | India |
| Research Site | Recruiting | Coimbatore | 641028 | India |
| Research Site | Recruiting | Dehradun | 248001 | India |
| Research Site | Recruiting | Delhi | 110029 | India |
| Research Site | Withdrawn | Faridabad | 121012 | India |
| Research Site | Recruiting | Gurgaon | 122001 | India |
| Research Site | Recruiting | Kochi | 682027 | India |
| Research Site | Suspended | Lucknow | 226003 | India |
| Research Site | Recruiting | New Delhi | 110005 | India |
| Research Site | Recruiting | Vadodara | 391760 | India |
| Research Site | Recruiting | Haifa | 3109601 | Israel |
| Research Site | Recruiting | Jerusalem | 91120 | Israel |
| Research Site | Recruiting | Kfar Saba | 44281 | Israel |
| Research Site | Recruiting | Ramat Gan | 52621 | Israel |
| Research Site | Not yet recruiting | Rehovot | 76100 | Israel |
| Research Site | Recruiting | Catania | 95123 | Italy |
| Research Site | Recruiting | Foggia | 71100 | Italy |
| Research Site | Recruiting | Genoa | 16132 | Italy |
| Research Site | Recruiting | Roma | 00168 | Italy |
| Research Site | Recruiting | Fukuoka | 811-1394 | Japan |
| Research Site | Recruiting | Ginowan-shi | 901-2214 | Japan |
| Research Site | Recruiting | Hiroshima | 730-0013 | Japan |
| Research Site | Recruiting | Ishinomaki | 986-8522 | Japan |
| Research Site | Recruiting | Kawaguchi-shi | 332-8558 | Japan |
| Research Site | Recruiting | Kiyose-shi | 204-8585 | Japan |
| Research Site | Recruiting | Kobe | 650-0017 | Japan |
| Research Site | Recruiting | Meguro-ku | 152-8902 | Japan |
| Research Site | Recruiting | Miura | 238-0111 | Japan |
| Research Site | Recruiting | Neyagawa | 572-8551 | Japan |
| Research Site | Recruiting | Sapporo | 060-0033 | Japan |
| Research Site | Recruiting | Sapporo | 064-0804 | Japan |
| Research Site | Recruiting | Takamatsu | 761-8073 | Japan |
| Research Site | Recruiting | Ube | 755-8505 | Japan |
| Research Site | Recruiting | Yokohama | 232-0024 | Japan |
| Research Site | Recruiting | Yokohama | 232-0066 | Japan |
| Research Site | Recruiting | Yokohama | 245-8575 | Japan |
| Research Site | Recruiting | Lima | 15046 | Peru |
| Research Site | Recruiting | Lima | 15082 | Peru |
| Research Site | Recruiting | Lima | 15088 | Peru |
| Research Site | Recruiting | Lima | LIMA 1 | Peru |
| Research Site | Withdrawn | Lima | LIMA 21 | Peru |
| Research Site | Suspended | Lima | LIMA 33 | Peru |
| Research Site | Recruiting | Iloilo City | 5000 | Philippines |
| Research Site | Withdrawn | Las Piñas | 1742 | Philippines |
| Research Site | Recruiting | Lipa City | 4217 | Philippines |
| Research Site | Recruiting | Manadaluyong City | 1552 | Philippines |
| Research Site | Recruiting | Quezon City | 1100 | Philippines |
| Research Site | Withdrawn | Roxas City | 5800 | Philippines |
| Research Site | Recruiting | Bellville | 7530 | South Africa |
| Research Site | Recruiting | Benoni | 1501 | South Africa |
| Research Site | Recruiting | Brackenfell | 7560 | South Africa |
| Research Site | Recruiting | Cape Town | 7700 | South Africa |
| Research Site | Recruiting | Durban | 4093 | South Africa |
| Research Site | Recruiting | eMkhomazi | 4170 | South Africa |
| Research Site | Recruiting | Somerset West | 7130 | South Africa |
| Research Site | Recruiting | Cheongju-si | 28644 | South Korea |
| Research Site | Recruiting | Daegu | 42415 | South Korea |
| Research Site | Recruiting | Seoul | 03080 | South Korea |
| Research Site | Recruiting | Seoul | 03312 | South Korea |
| Research Site | Recruiting | Seoul | 03722 | South Korea |
| Research Site | Recruiting | Seoul | 05505 | South Korea |
| Research Site | Recruiting | Seoul | 06591 | South Korea |
| Research Site | Recruiting | Seoul | 08308 | South Korea |
| Research Site | Recruiting | Barcelona | 08003 | Spain |
| Research Site | Recruiting | Barcelona | 8025 | Spain |
| Research Site | Recruiting | Madrid | 28041 | Spain |
| Research Site | Recruiting | Málaga | 29010 | Spain |
| Research Site | Withdrawn | Mérida | 06800 | Spain |
| Research Site | Recruiting | Patraix | 46017 | Spain |
| Research Site | Recruiting | Santander | 39008 | Spain |
| Research Site | Recruiting | Kaohsiung City | 80756 | Taiwan |
| Research Site | Recruiting | New Taipei City | 231 | Taiwan |
| Research Site | Recruiting | Taichung | 40705 | Taiwan |
| Research Site | Recruiting | Taichung | 433004 | Taiwan |
| Research Site | Recruiting | Taipei | 10002 | Taiwan |
| Research Site | Recruiting | Taipei | 110 | Taiwan |
| Research Site | Recruiting | Taipei | 11220 | Taiwan |
| Research Site | Recruiting | Taipei | 11696 | Taiwan |
| Research Site | Recruiting | Bangkok | 10700 | Thailand |
| Research Site | Recruiting | Chanthaburi | 22000 | Thailand |
| Research Site | Recruiting | Chiang Rai | 57000 | Thailand |
| Research Site | Recruiting | Chon Buri | 20000 | Thailand |
| Research Site | Recruiting | Khon Kaen | 40002 | Thailand |
| Research Site | Recruiting | Nakhon Sri Thammarat | 80000 | Thailand |
| Research Site | Recruiting | Adana | 01330 | Turkey (Türkiye) |
| Research Site | Recruiting | Ankara | 06280 | Turkey (Türkiye) |
| Research Site | Recruiting | Bursa | 16059 | Turkey (Türkiye) |
| Research Site | Recruiting | Gaziantep | 27470 | Turkey (Türkiye) |
| Research Site | Recruiting | Istanbul | 34890 | Turkey (Türkiye) |
| Research Site | Recruiting | Kayseri | 38039 | Turkey (Türkiye) |
| Research Site | Recruiting | Mersin | 33079 | Turkey (Türkiye) |
| Research Site | Recruiting | Da Nang | 550000 | Vietnam |
| Research Site | Recruiting | Haiphong | 180000 | Vietnam |
| Research Site | Recruiting | Hanoi | 100000 | Vietnam |
| Research Site | Recruiting | Ho Chi Minh City | 10000 | Vietnam |
| Research Site | Recruiting | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Withdrawn | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Recruiting | Huế | 530000 | Vietnam |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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