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

Last updated: May 6, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Tozorakimab

Placebo

Clinical Study ID

NCT06932263
D9181C00002
2024-519116-14-00
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated written informed consent prior to any study-specificprocedures.

  2. Adults aged 18-75, inclusive when signing the informed consent.

  3. Documented physician-diagnosis of asthma for at least 12 months.

  4. Treated with medium or high dose ICS in combination with LABA.

  5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .

  6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.

  7. Documented exacerbation history in the last 12 months and biomarker requirements of:

  8. 2 severe exacerbations OR

  9. 1 severe exacerbation and:

(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb

  1. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.

  2. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.

  3. Contraceptive use by males and females should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

Exclusion

Exclusion Criteria:

  1. Completed treatment for respiratory infection with antibiotics in the 4 weeks priorto Visit 1.

  2. Clinically significant pulmonary disease other than asthma .

  3. Current smokers, former smokers with >10 pack-years history.

  4. Clinically significant aortic stenosis or pulmonary arterial hypertension.

  5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immunecomplex disease.

  6. Unstable cardiovascular disorders.

Study Design

Total Participants: 540
Treatment Group(s): 2
Primary Treatment: Tozorakimab
Phase: 2
Study Start date:
March 26, 2025
Estimated Completion Date:
March 16, 2028

Connect with a study center

  • Research Site

    Caba, C1425BEN
    Argentina

    Site Not Available

  • Research Site

    Ciudad Autonoma de Buenos Aires, 1128
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, 1425
    Argentina

    Site Not Available

  • Research Site

    La Plata, B1900
    Argentina

    Site Not Available

  • Research Site

    Mendoza, 5500
    Argentina

    Site Not Available

  • Research Site

    Rosario, 2000
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Research Site

    Caxias do Sul, 95070-560
    Brazil

    Site Not Available

  • Research Site

    Criciuma, 88811-000
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 91350-200
    Brazil

    Site Not Available

  • Research Site

    Salvador, 40050 410
    Brazil

    Site Not Available

  • Research Site

    Santo Andre, 09080-110
    Brazil

    Site Not Available

  • Research Site

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 04014-002
    Brazil

    Site Not Available

  • Research Site

    Sorocaba, 18040-425
    Brazil

    Site Not Available

  • Research Site

    Curico, 3341643
    Chile

    Site Not Available

  • Research Site

    Quillota, 2260000
    Chile

    Site Not Available

  • Research Site

    Santiago, 7500657
    Chile

    Site Not Available

  • Research Site

    Victoria, 4720000
    Chile

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    Viña del Mar, 2540488
    Chile

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  • Research Site

    Chengdu, 610000
    China

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  • Research Site

    Chongqing, 400010
    China

    Site Not Available

  • Research Site

    Guangzhou, 510163
    China

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  • Research Site

    Haikou, 570311
    China

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  • Research Site

    Hefei, 230061
    China

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    Huizhou, 516001
    China

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    Shanghai, 200025
    China

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    Shenzhen, 518020
    China

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    Wenzhou, 325027
    China

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    Brest Cedex, 29200
    France

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    Creteil, 94010
    France

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    Lyon Cedex 04, 69317
    France

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    Marseille, 13015
    France

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    Pessac, 33604
    France

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    Strasbourg Cedex, 67091
    France

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    Suresnes, 92150
    France

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    Athens, 17562
    Greece

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    Ioannina, 45500
    Greece

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    Patras, 26500
    Greece

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    Thessaloniki, 57001
    Greece

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    Balassagyarmat, 2660
    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
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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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    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-shi, 811-1394
    Japan

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    Ginowan-shi, 901-2214
    Japan

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    Ishinomaki, 986-8522
    Japan

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    Kagoshima City, 890-0053
    Japan

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    Kawaguchi-shi, 332-8558
    Japan

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    Kiyose-shi, 204-8585
    Japan

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    Kobe-shi, 650-0017
    Japan

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    Meguro-ku, 152-8902
    Japan

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  • Research Site

    Miura city, 238-0111
    Japan

    Active - Recruiting

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    Sapporo-shi, 064-0804
    Japan

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    Takamatsu-shi, 761-8073
    Japan

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  • Research Site

    Ube, 755-8505
    Japan

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    Yokohama, 232-0066
    Japan

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    Yokohama-shi, 232-0024
    Japan

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    Cheongju-si, 28644
    Korea, Republic of

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    Daegu, 42415
    Korea, Republic of

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    Seoul, 05505
    Korea, Republic of

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    Lima, LIMA 21
    Peru

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    Iloilo City, 5000
    Philippines

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    Las Pinas, 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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    Benoni, 1501
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    Brackenfell, 7560
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    Cape Town, 7700
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    Durban, 4093
    South Africa

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    Somerset West, 7130
    South Africa

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    Tygervalley, 7530
    South Africa

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    Umkomaas, 4170
    South Africa

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    Barcelona, 08003
    Spain

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    Madrid, 28041
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    Merida, 06800
    Spain

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    Málaga, 29010
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    Patraix, 46017
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    Santander, 39008
    Spain

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  • Research Site

    Kaohsiung, 80756
    Taiwan

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    New Taipei, 231
    Taiwan

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    Taichung, 40705
    Taiwan

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    Taichung City, 433004
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 11220
    Taiwan

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    Taipei City, 110
    Taiwan

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    Bangkok, 10700
    Thailand

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    Chiang Rai, 57000
    Thailand

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    Chonburi, 20000
    Thailand

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    Khon Kaen, 40002
    Thailand

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  • Research Site

    Mueang Chanthaburi, 22000
    Thailand

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    Nakhon Sri Thammarat, 80000
    Thailand

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  • Research Site

    Bakersfield, California 93301
    United States

    Active - Recruiting

  • Research Site

    Huntington Beach, California 92647
    United States

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  • Research Site

    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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  • Research Site

    Cutler Bay, Florida 33189
    United States

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  • Research Site

    Hialeah, Florida 33012
    United States

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  • Research Site

    Leesburg, Florida 34748
    United States

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  • Research Site

    Miami, Florida 33175
    United States

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  • Research Site

    Orlando, Florida 32819
    United States

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  • Research Site

    Palmetto Bay, Florida 33157
    United States

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  • Research Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Research Site

    Winter Park, Florida 32789
    United States

    Site Not Available

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    Boise, Idaho 83706
    United States

    Site Not Available

  • Research Site

    Indianapolis, Indiana 46268
    United States

    Active - Recruiting

  • Research Site

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40218
    United States

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  • Research Site

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • Research Site

    Farmington Hills, Michigan 48336
    United States

    Active - Recruiting

  • Research Site

    Warren, Michigan 48088
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63141
    United States

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    Bellevue, Nebraska 68123
    United States

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  • Research Site

    Grand Island, Nebraska 68803
    United States

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  • Research Site

    Omaha, Nebraska 68134
    United States

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  • Research Site

    Toms River, New Jersey 08755
    United States

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  • Research Site

    Maspeth, New York 11378
    United States

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  • Research Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Research Site

    Huntersville, North Carolina 28078
    United States

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  • Research Site

    Kings Mountain, North Carolina 28086
    United States

    Active - Recruiting

  • Research Site

    Toledo, Ohio 43617
    United States

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  • Research Site

    Edmond, Oklahoma 73034
    United States

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  • Research Site

    Grants Pass, Oregon 97527
    United States

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  • Research Site

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97202
    United States

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    DuBois, Pennsylvania 15801
    United States

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  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Research Site

    Smithfield, Pennsylvania 15478
    United States

    Active - Recruiting

  • Research Site

    Rock Hill, South Carolina 29732
    United States

    Active - Recruiting

  • Research Site

    Knoxville, Tennessee 37919
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Research Site

    Forney, Texas 75126
    United States

    Active - Recruiting

  • Research Site

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Research Site

    Tyler, Texas 75708
    United States

    Site Not Available

  • Research Site

    Victoria, Texas 77901
    United States

    Active - Recruiting

  • Research Site

    Roy, Utah 84067
    United States

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  • Research Site

    Bellingham, Washington 98225
    United States

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  • Research Site

    Milwaukee, Wisconsin 53228
    United States

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  • Research Site

    Da Nang, 550000
    Vietnam

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  • Research Site

    Hai Phong, 180000
    Vietnam

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  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Hue, 530000
    Vietnam

    Site Not Available

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