AsthmaPhase 2UmbrielNCT06932263

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

A Phase 2 study testing Tozorakimab in people with Asthma, run by AstraZeneca at 222 sites in 21 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: Tozorakimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 540 participants
Where: 222 sitesin 21 countries
Study dates: 26 Mar 2025to 28 Feb 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 13Show fewer

Documented exacerbation history in the last 12 months and biomarker requirements of:
≥ 2 severe exacerbations OR
1 severe exacerbation and:
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.

Who cannot join

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.

Trial locations and contacts

222 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

222 sites in 21 countries

United States64 sites, 32 recruiting

Research Site
Asheville, North Carolina, 28803
Withdrawn
Research Site
Austin, Texas, 78759
Recruiting
Research Site
Bakersfield, California, 93301
Recruiting
Research Site
Bellevue, Nebraska, 68123
Withdrawn
Research Site
Bellingham, Washington, 98225
Terminated
Research Site
Boerne, Texas, 78006
Not yet recruiting
Research Site
Boise, Idaho, 83706
Withdrawn
Research Site
Cutler Bay, Florida, 33189
Suspended
Research Site
Dallas, Texas, 75254
Not yet recruiting
Research Site
DuBois, Pennsylvania, 15801
Terminated
Research Site
Edmond, Oklahoma, 73034
Withdrawn
Research Site
El Paso, Texas, 79912
Not yet recruiting
Research Site
Farmington Hills, Michigan, 48336
Recruiting
Research Site
Forney, Texas, 75126
Terminated
Research Site
Grand Island, Nebraska, 68803
Recruiting
Research Site
Grants Pass, Oregon, 97527
Withdrawn
Research Site
Greenville, Texas, 75401
Not yet recruiting
Research Site
Hialeah, Florida, 33015
Suspended
Research Site
Horseheads, New York, 14845
Not yet recruiting
Research Site
Huntersville, North Carolina, 28078
Withdrawn
Research Site
Huntington Beach, California, 92647
Withdrawn
Research Site
Hutchinson, Kansas, 67502
Not yet recruiting
Research Site
Kansas City, Kansas, 66160
Withdrawn
Research Site
Kings Mountain, North Carolina, 28086
Recruiting
Research Site
Kingwood, Texas, 77339
Recruiting
Research Site
Kingwood, West Virginia, 26537
Recruiting
Research Site
Knoxville, Tennessee, 37919
Terminated
Research Site
La Mesa, California, 91942
Terminated
Research Site
Leesburg, Florida, 34748
Withdrawn
Research Site
Loma Linda, California, 92354
Withdrawn
Research Site
Long Beach, California, 90815
Withdrawn
Research Site
Louisville, Kentucky, 40218
Recruiting
Research Site
Maspeth, New York, 11378
Recruiting
Research Site
McKinney, Texas, 75069
Not yet recruiting
Research Site
Medford, Oregon, 97504
Recruiting
Research Site
Miami, Florida, 33155
Suspended
Research Site
Miami, Florida, 33175
Suspended
Research Site
Miami Lakes, Florida, 33016
Suspended
Research Site
Millville, New Jersey, 08332
Not yet recruiting
Research Site
Milwaukee, Wisconsin, 53228
Recruiting
Research Site
Newport Beach, California, 92663
Recruiting
Research Site
Noblesville, Indiana, 46060
Recruiting
Research Site
Omaha, Nebraska, 68134
Recruiting
Research Site
Orlando, Florida, 32819
Suspended
Research Site
Palmetto Bay, Florida, 33157
Suspended
Research Site
Philadelphia, Pennsylvania, 19140
Recruiting
Research Site
Pinehurst, North Carolina, 28374
Withdrawn
Research Site
Portland, Oregon, 97202
Recruiting
Research Site
Rock Hill, South Carolina, 29732
Recruiting
Research Site
Roy, Utah, 84067
Terminated
Research Site
San Jose, California, 95117
Recruiting
Research Site
Smithfield, Pennsylvania, 15478
Recruiting
Research Site
St Louis, Missouri, 63141
Withdrawn
Research Site
Sugar Land, Texas, 77478
Not yet recruiting
Research Site
Tampa, Florida, 33607
Suspended
Research Site
Toledo, Ohio, 43617
Recruiting
Research Site
Toms River, New Jersey, 08755
Recruiting
Research Site
Victoria, Texas, 77901
Recruiting
Research Site
Warren, Michigan, 48088
Withdrawn
Research Site
West Des Moines, Iowa, 50266
Terminated
Research Site
White Marsh, Maryland, 21162
Withdrawn
Research Site
Wilmington, Delaware, 19805
Terminated
Research Site
Winter Park, Florida, 32789
Suspended
Research Site
Worcester, Massachusetts, 01605
Not yet recruiting

Other trials in United States

Japan17 sites, 17 recruiting

Research Site
Fukuoka, 811-1394
Recruiting
Research Site
Ginowan-shi, 901-2214
Recruiting
Research Site
Hiroshima, 730-0013
Recruiting
Research Site
Ishinomaki, 986-8522
Recruiting
Research Site
Kawaguchi-shi, 332-8558
Recruiting
Research Site
Kiyose-shi, 204-8585
Recruiting
Research Site
Kobe, 650-0017
Recruiting
Research Site
Meguro-ku, 152-8902
Recruiting
Research Site
Miura, 238-0111
Recruiting
Research Site
Neyagawa, 572-8551
Recruiting
Research Site
Sapporo, 060-0033
Recruiting
Research Site
Sapporo, 064-0804
Recruiting
Research Site
Takamatsu, 761-8073
Recruiting
Research Site
Ube, 755-8505
Recruiting
Research Site
Yokohama, 232-0024
Recruiting
Research Site
Yokohama, 232-0066
Recruiting
Research Site
Yokohama, 245-8575
Recruiting

Other trials in Japan

China16 sites, 16 recruiting

Research Site
Baotou, 014010
Recruiting
Research Site
Changchun, 130021
Recruiting
Research Site
Chengdu, 610000
Recruiting
Research Site
Chongqing, 400010
Recruiting
Research Site
Guangzhou, 510163
Recruiting
Research Site
Haikou, 570311
Recruiting
Research Site
Hefei, 230061
Recruiting
Research Site
Hohhot, 10050
Recruiting
Research Site
Huizhou, 516001
Recruiting
Research Site
Qingdao, 266011
Recruiting
Research Site
Shanghai, 200025
Recruiting
Research Site
Shanghai, 200065
Recruiting
Research Site
Shanghai, 201114
Recruiting
Research Site
Shenzhen, 518020
Recruiting
Research Site
Wenzhou, 325027
Recruiting
Research Site
Xuzhou, 221000
Recruiting

Other trials in China

Brazil10 sites, 7 recruiting

Research Site
Caxias do Sul, 95070-560
Withdrawn
Research Site
Criciúma, 88811-000
Recruiting
Research Site
Porto Alegre, 9061-000
Recruiting
Research Site
Porto Alegre, 91350-200
Recruiting
Research Site
Salvador, 40050 410
Withdrawn
Research Site
Santo André, 09080-110
Withdrawn
Research Site
São José do Rio Preto, 15090-000
Recruiting
Research Site
São Paulo, 04014-002
Recruiting
Research Site
São Paulo, 05403-000
Recruiting
Research Site
Sorocaba, 18040-425
Recruiting

Other trials in Brazil

India10 sites, 6 recruiting

Research Site
Belagavi, 590010
Recruiting
Research Site
Coimbatore, 641028
Recruiting
Research Site
Dehradun, 248001
Recruiting
Research Site
Delhi, 110029
Recruiting
Research Site
Faridabad, 121012
Withdrawn
Research Site
Gūrgaon, 122001
Withdrawn
Research Site
Kochi, 682027
Terminated
Research Site
Lucknow, 226003
Suspended
Research Site
New Delhi, 110005
Recruiting
Research Site
Vadodara, 391760
Recruiting

Other trials in India

South Korea8 sites, 8 recruiting

Research Site
Cheongju-si, 28644
Recruiting
Research Site
Daegu, 42415
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 03312
Recruiting
Research Site
Seoul, 03722
Recruiting
Research Site
Seoul, 05505
Recruiting
Research Site
Seoul, 06591
Recruiting
Research Site
Seoul, 08308
Recruiting

Other trials in South Korea

Taiwan8 sites, 7 recruiting

Research Site
Kaohsiung City, 80756
Recruiting
Research Site
New Taipei City, 231
Withdrawn
Research Site
Taichung, 40705
Recruiting
Research Site
Taichung, 433004
Recruiting
Research Site
Taipei, 10002
Recruiting
Research Site
Taipei, 110
Recruiting
Research Site
Taipei, 11220
Recruiting
Research Site
Taipei, 11696
Recruiting

Other trials in Taiwan

Argentina7 sites, 6 recruiting

Research Site
CABA, C1425BEN
Recruiting
Research Site
Ciudad de Buenos Aires, 1128
Withdrawn
Research Site
Ciudad de Buenos Aires, 1425
Recruiting
Research Site
La Plata, B1900
Recruiting
Research Site
Mendoza, 5500
Recruiting
Research Site
Rosario, 2000
Recruiting
Research Site
San Miguel de Tucumán, 4000
Recruiting

Other trials in Argentina

Chile7 sites

Research Site
Curicó, 3341643
Active, not recruiting
Research Site
Quillota, 2260000
Active, not recruiting
Research Site
Santiago, 7500657
Active, not recruiting
Research Site
Santiago, 7501126
Active, not recruiting
Research Site
Santiago, 7750495
Active, not recruiting
Research Site
Temuco, 4810345
Active, not recruiting
Research Site
Viña del Mar, 2540488
Active, not recruiting

Other trials in Chile

France7 sites, 7 recruiting

Research Site
Brest, 29200
Recruiting
Research Site
Créteil, 94010
Recruiting
Research Site
Lyon, 69317
Recruiting
Research Site
Marseille, 13015
Recruiting
Research Site
Pessac, 33604
Recruiting
Research Site
Strasbourg, 67091
Recruiting
Research Site
Suresnes, 92150
Recruiting

Other trials in France

Hungary7 sites

Research Site
Balassagyarmat, 2660
Active, not recruiting
Research Site
Budapest, 1036
Withdrawn
Research Site
Budapest, 1121
Withdrawn
Research Site
Debrecen, 4032
Active, not recruiting
Research Site
Gödöllő, 2100
Active, not recruiting
Research Site
Pécs, 7635
Active, not recruiting
Research Site
Törökbálint, 2045
Active, not recruiting

Other trials in Hungary

South Africa7 sites, 7 recruiting

Research Site
Bellville, 7530
Recruiting
Research Site
Benoni, 1501
Recruiting
Research Site
Brackenfell, 7560
Recruiting
Research Site
Cape Town, 7700
Recruiting
Research Site
Durban, 4093
Recruiting
Research Site
eMkhomazi, 4170
Recruiting
Research Site
Somerset West, 7130
Recruiting

Other trials in South Africa

Spain7 sites, 6 recruiting

Research Site
Barcelona, 08003
Recruiting
Research Site
Barcelona, 8025
Recruiting
Research Site
Madrid, 28041
Recruiting
Research Site
Málaga, 29010
Recruiting
Research Site
Mérida, 06800
Withdrawn
Research Site
Patraix, 46017
Recruiting
Research Site
Santander, 39008
Recruiting

Other trials in Spain

Turkey (Türkiye)7 sites, 7 recruiting

Research Site
Adana, 01330
Recruiting
Research Site
Ankara, 06280
Recruiting
Research Site
Bursa, 16059
Recruiting
Research Site
Gaziantep, 27470
Recruiting
Research Site
Istanbul, 34890
Recruiting
Research Site
Kayseri, 38039
Recruiting
Research Site
Mersin, 33079
Recruiting

Other trials in Turkey (Türkiye)

Vietnam7 sites, 6 recruiting

Research Site
Da Nang, 550000
Recruiting
Research Site
Haiphong, 180000
Recruiting
Research Site
Hanoi, 100000
Recruiting
Research Site
Ho Chi Minh City, 10000
Recruiting
Research Site
Ho Chi Minh City, 700000
Recruiting
Research Site
Ho Chi Minh City, 700000
Withdrawn
Research Site
Huế, 530000
Recruiting

Other trials in Vietnam

Greece6 sites

Research Site
Athens, 11521
Active, not recruiting
Research Site
Athens, 17562
Active, not recruiting
Research Site
Ioannina, 45500
Withdrawn
Research Site
Pátrai, 26500
Active, not recruiting
Research Site
Thessaloniki, 57001
Active, not recruiting
Research Site
Thessaloniki, 57010
Active, not recruiting

Other trials in Greece

Peru6 sites, 4 recruiting

Research Site
Lima, 15046
Recruiting
Research Site
Lima, 15082
Recruiting
Research Site
Lima, 15088
Recruiting
Research Site
Lima, LIMA 1
Recruiting
Research Site
Lima, LIMA 21
Withdrawn
Research Site
Lima, LIMA 33
Withdrawn

Other trials in Peru

Philippines6 sites, 4 recruiting

Research Site
Iloilo City, 5000
Recruiting
Research Site
Las Piñas, 1742
Withdrawn
Research Site
Lipa, 4217
Recruiting
Research Site
Manadaluyong City, 1552
Recruiting
Research Site
Quezon City, 1100
Recruiting
Research Site
Roxas City, 5800
Withdrawn

Other trials in Philippines

Thailand6 sites, 6 recruiting

Research Site
Bangkok, 10700
Recruiting
Research Site
Chanthaburi, 22000
Recruiting
Research Site
Chiang Rai, 57000
Recruiting
Research Site
Chon Buri, 20000
Recruiting
Research Site
Khon Kaen, 40002
Recruiting
Research Site
Nakhon Sri Thammarat, 80000
Recruiting

Other trials in Thailand

Israel5 sites, 5 recruiting

Research Site
Haifa, 3109601
Recruiting
Research Site
Jerusalem, 91120
Recruiting
Research Site
Kfar Saba, 44281
Recruiting
Research Site
Ramat Gan, 52621
Recruiting
Research Site
Rehovot, 76100
Recruiting

Other trials in Israel

Italy4 sites, 4 recruiting

Research Site
Catania, 95123
Recruiting
Research Site
Foggia, 71100
Recruiting
Research Site
Genoa, 16132
Recruiting
Research Site
Roma, 00168
Recruiting

Other trials in Italy

About this study

Official title: 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

Conditions: Asthma
Being tested: Tozorakimab, Placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TozorakimabDrug
The drug will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.

Study groups in NCT06932263
Study group	Role	What they receive
Tozorakimab Dose 1	Experimental	Dosing subcutaneously tozorakimab Dose 1 Receives: Drug: Tozorakimab
Tozorakimab Dose 2	Experimental	Dosing subcutaneously tozorakimab Dose 2 and placebo Receives: Drug: Tozorakimab
Placebo	Placebo comparator	Dosing subcutaneously with equivalent volume to tozorakimab Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Over 26 to 52 weeks

Secondary outcomes (8)

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.
Measured: Over 26 to 52 weeks
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.
Measured: 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.
Measured: Over weeks 20 to 26
Change from baseline in post-bronchodilator FEV1
Difference in mean change from baseline between tozorakimab and placebo.
Measured: 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.
Measured: 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.
Measured: At week 26
Trough serum concentrations of tozorakimab
Pharmacokinetics: concentrations of tozorakimab in trough serum.
Measured: Over 52 weeks
Anti-drug antibody incidence
Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab
Measured: Over 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202528 Feb 2028

First posted17 Apr 2025
Study start26 Mar 2025
Primary completion7 Jun 2027 (estimated)
Study completion28 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 540 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06932263
Sponsor's protocol ID: D9181C00002
Other IDs: 2024-519116-14-00
Acronym: Umbriel
Status last verified: Aug 2026
First submitted: 1 Apr 2025
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06932263
Acronym / sponsor ID: Umbriel / D9181C00002
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 540 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Mar 2025 (actual)
Primary completion: 7 Jun 2027 (estimated)
Study completion: 28 Feb 2028 (estimated)
First posted: 17 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Tozorakimab Dose 1	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 1
Tozorakimab Dose 2	Experimental	Drug: TozorakimabDosing subcutaneously tozorakimab Dose 2 and placebo
Placebo	Placebo comparator	Drug: PlaceboDosing subcutaneously with equivalent volume to tozorakimab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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 .

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TozorakimabThe drug will be administered subcutaneously.	Drug	Tozorakimab Dose 1, Tozorakimab Dose 2
PlaceboPlacebo will be administered subcutaneously.	Drug	Placebo

Primary outcome

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.

8 secondary outcomes

Annualised rate of severe asthma exacerbations
Time frame: Over 26 to 52 weeks
Time to first severe asthma exacerbation
Time frame: 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
Change from baseline in post-bronchodilator FEV1
Time frame: At week 26
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)
Time frame: At week 26
Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)
Time frame: At week 26
Trough serum concentrations of tozorakimab
Time frame: Over 52 weeks
Anti-drug antibody incidence
Time frame: Over 52 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for Asthma

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

222 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tozorakimab in people with Asthma, run by AstraZeneca at 222 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States, Japan, China, Brazil, India and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualised rate of severe asthma exacerbations (time frame: Over 26 to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06932263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.