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
2 other identifiers
interventional
540
21 countries
209
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Mar 2025
Longer than P75 for phase_2 asthma
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2025
CompletedFirst Submitted
Initial submission to the registry
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 16, 2028
April 9, 2026
April 1, 2026
2.2 years
April 1, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Annualised rate of severe asthma exacerbations
Over 26 to 52 weeks
Time to first severe asthma exacerbation
Over 26 to 52 weeks
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Over weeks 20 to 26
Change from baseline in post-bronchodilator FEV1
At week 26
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)
At week 26
- +3 more secondary outcomes
Study Arms (3)
Tozorakimab Dose 1
EXPERIMENTALDosing subcutaneously tozorakimab Dose 1
Tozorakimab Dose 2
EXPERIMENTALDosing subcutaneously tozorakimab Dose 2 and placebo
Placebo
PLACEBO COMPARATORDosing subcutaneously with equivalent volume to tozorakimab
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- severe exacerbations OR
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (209)
Research Site
Bakersfield, California, 93301, United States
Research Site
Huntington Beach, California, 92647, United States
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La Mesa, California, 91942, United States
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Newport Beach, California, 92663, United States
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San Jose, California, 95117, United States
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Wilmington, Delaware, 19805, United States
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Cutler Bay, Florida, 33189, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33015, United States
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Leesburg, Florida, 34748, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33175, United States
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Orlando, Florida, 32819, United States
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Palmetto Bay, Florida, 33157, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Boise, Idaho, 83706, United States
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Indianapolis, Indiana, 46268, United States
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West Des Moines, Iowa, 50266, United States
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Louisville, Kentucky, 40218, United States
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White Marsh, Maryland, 21162, United States
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Farmington Hills, Michigan, 48336, United States
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Warren, Michigan, 48088, United States
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St Louis, Missouri, 63141, United States
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Bellevue, Nebraska, 68123, United States
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Grand Island, Nebraska, 68803, United States
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Omaha, Nebraska, 68134, United States
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Toms River, New Jersey, 08755, United States
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Maspeth, New York, 11378, United States
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Asheville, North Carolina, 28803, United States
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Huntersville, North Carolina, 28078, United States
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Kings Mountain, North Carolina, 28086, United States
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Toledo, Ohio, 43617, United States
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Edmond, Oklahoma, 73034, United States
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Grants Pass, Oregon, 97527, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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DuBois, Pennsylvania, 15801, United States
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Philadelphia, Pennsylvania, 19140, United States
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Smithfield, Pennsylvania, 15478, United States
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Rock Hill, South Carolina, 29732, United States
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Knoxville, Tennessee, 37919, United States
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Austin, Texas, 78759, United States
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Forney, Texas, 75126, United States
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Kingwood, Texas, 77339, United States
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Tyler, Texas, 75708, United States
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Victoria, Texas, 77901, United States
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Roy, Utah, 84067, United States
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Bellingham, Washington, 98225, United States
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Kingwood, West Virginia, 26537, United States
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Milwaukee, Wisconsin, 53228, United States
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1128, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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La Plata, B1900, Argentina
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Mendoza, 5500, Argentina
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Rosario, 2000, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Caxias do Sul, 95070-560, Brazil
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Criciúma, 88811-000, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Salvador, 40050 410, Brazil
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Santo André, 09080-110, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04014-002, Brazil
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São Paulo, 05403-000, Brazil
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Sorocaba, 18040-425, Brazil
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Curicó, 3341643, Chile
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Quillota, 2260000, Chile
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Santiago, 7500657, Chile
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Santiago, 7501126, Chile
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Santiago, 7750495, Chile
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Temuco, 4810345, Chile
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Viña del Mar, 2540488, Chile
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Baotou, 014010, China
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Changchun, 130021, China
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Chengdu, 610000, China
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Chongqing, 400010, China
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Guangzhou, 510163, China
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Haikou, 570311, China
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Hefei, 230061, China
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Hohhot, 10050, China
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Huizhou, 516001, China
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Qingdao, 266011, China
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Shanghai, 200025, China
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Shanghai, 200065, China
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Shanghai, 201114, China
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Shenzhen, 518020, China
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Wenzhou, 325027, China
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Xuzhou, 221000, China
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Brest, 29200, France
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Créteil, 94010, France
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Lyon, 69317, France
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Marseille, 13015, France
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Pessac, 33604, France
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Strasbourg, 67091, France
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Suresnes, 92150, France
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Athens, 11521, Greece
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Athens, 17562, Greece
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Ioannina, 45500, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 57001, Greece
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Thessaloniki, 57010, Greece
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Balassagyarmat, 2660, Hungary
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Budapest, 1036, Hungary
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Budapest, 1121, Hungary
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Debrecen, 4032, Hungary
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Gödöllő, 2100, Hungary
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Pécs, 7635, Hungary
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Törökbálint, 2045, Hungary
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Faridabad, 121012, India
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Gūrgaon, 122001, India
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Kochi, 682027, India
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Lucknow, 226003, India
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New Delhi, 110005, India
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Vadodara, 391760, India
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Catania, 95123, Italy
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Foggia, 71100, Italy
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Genoa, 16132, Italy
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Roma, 00168, Italy
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Fukuoka, 811-1394, Japan
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Ginowan-shi, 901-2214, Japan
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Hiroshima, 730-0013, Japan
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Ishinomaki, 986-8522, Japan
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Kawaguchi-shi, 332-8558, Japan
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Kiyose-shi, 204-8585, Japan
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Kobe, 650-0017, Japan
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Meguro-ku, 152-8902, Japan
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Miura, 238-0111, Japan
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Neyagawa, 572-8551, Japan
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Sapporo, 060-0033, Japan
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Sapporo, 064-0804, Japan
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Takamatsu, 761-8073, Japan
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Ube, 755-8505, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 232-0066, Japan
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Yokohama, 245-8575, Japan
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Lima, 15046, Peru
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Lima, 15082, Peru
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Lima, 15088, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 33, Peru
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Iloilo City, 5000, Philippines
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Las Piñas, 1742, Philippines
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Lipa City, 4217, Philippines
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Manadaluyong City, 1552, Philippines
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Quezon City, 1100, Philippines
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Roxas City, 5800, Philippines
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Bellville, 7530, South Africa
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Benoni, 1501, South Africa
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Brackenfell, 7560, South Africa
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Cape Town, 7700, South Africa
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Durban, 4093, South Africa
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eMkhomazi, 4170, South Africa
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Somerset West, 7130, South Africa
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Cheongju-si, 28644, South Korea
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Daegu, 42415, South Korea
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Seoul, 03080, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
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Barcelona, 08003, Spain
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Barcelona, 8025, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Patraix, 46017, Spain
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Santander, 39008, Spain
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Kaohsiung City, 80756, Taiwan
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New Taipei City, 231, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11220, Taiwan
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Taipei, 11696, Taiwan
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Bangkok, 10700, Thailand
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Chanthaburi, 22000, Thailand
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Chiang Rai, 57000, Thailand
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Chon Buri, 20000, Thailand
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Khon Kaen, 40002, Thailand
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Nakhon Sri Thammarat, 80000, Thailand
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06280, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Gaziantep, 27470, Turkey (Türkiye)
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Istanbul, 34890, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Mersin, 33079, Turkey (Türkiye)
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Da Nang, 550000, Vietnam
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Haiphong, 180000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Research Site
Huế, 530000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2025
First Posted
April 17, 2025
Study Start
March 26, 2025
Primary Completion (Estimated)
June 24, 2027
Study Completion (Estimated)
March 16, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.