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Cure My Disease

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New shot every 6 months could slash severe asthma attacks

NCT ID NCT07359846

Disease control Sponsor: Generate Biomedicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 13 times

Summary

This study tests a new medicine called GB-0895 for people aged 12 to 80 with severe asthma that is not controlled by standard inhalers. Participants receive either GB-0895 or a placebo as a shot every 6 months for a year. The goal is to see if GB-0895 can reduce the number of serious asthma attacks requiring steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 786 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented physician diagnosis of asthma for ≥ 2 years. 3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months. 4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1. 5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \<80% predicted at Screening Visit 1. 6. Adolescents 12 to \< 18 years of age at Screening Visit 1: A pre-BD FEV1 \< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \< 0.80. 7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period. 8. ACQ-6 score ≥ 1.5 at the Screening Visit. 9. Weight ≥40 kg at the Screening Visit 1 Exclusion Criteria: 1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy. 2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer. 3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis). 4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study. 5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment. 6. A current malignancy or previous history of cancer within 5 years before screening. 7. Clinically significant infection that is not resolved before study enrollment. 8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1. 9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes. 10. Former smokers with a smoking history of \<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible. 11. Hepatitis B, C, or HIV. 12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \>1 day during the study. 13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives. 14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational. 15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization. 16. Receipt of an investigational biologic within 4 months or 5 half-lives, OR receipt of an investigational non-biologic within 30 days or 5 half-lives before Screening Visit 1. 17. Known history of sensitivity to any component of the study treatment formulation. 18. History of life-threatening anaphylaxis following any biologic therapy. 19. Concurrent enrollment in another clinical study involving investigational product (IP). 20. Subject has been randomized in the current study or previous GB-0895 studies. 21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion. 22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease. 23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1. 24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period. 25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1. 26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1. 27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator. 28. Women who are pregnant, lactating, or planning to become pregnant during the study. 29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    96 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research 09

    RECRUITING

    Orlando, Florida, 32807, United States

    Contact Email: •••••@•••••

  • Research Site 01

    RECRUITING

    Tamarac, Florida, 33321, United States

    Contact Email: •••••@•••••

  • Research Site 02

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

    Contact Email: •••••@•••••

  • Research Site 03

    RECRUITING

    Miami, Florida, 33135, United States

    Contact Email: •••••@•••••

  • Research Site 04

    RECRUITING

    Tampa, Florida, 33607, United States

    Contact Email: •••••@•••••

  • Research Site 05

    RECRUITING

    Tampa, Florida, 33617, United States

    Contact Email: •••••@•••••

  • Research Site 06

    RECRUITING

    Miami, Florida, 33126, United States

    Contact Email: •••••@•••••

  • Research Site 07

    RECRUITING

    Sugar Land, Texas, 77479, United States

    Contact Email: •••••@•••••

  • Research Site 08

    RECRUITING

    Williamsburg, Virginia, 23188, United States

    Contact Email: •••••@•••••

  • Research Site 10

    RECRUITING

    West Covina, California, 91790, United States

    Contact Email: •••••@•••••

  • Research Site 100

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

    Contact Email: •••••@•••••

  • Research Site 101

    RECRUITING

    Tartu, Tartu, 50708, Estonia

    Contact Email: •••••@•••••

  • Research Site 11

    RECRUITING

    Dayton, Ohio, 45424, United States

    Contact Email: •••••@•••••

  • Research Site 12

    RECRUITING

    Inglewood, California, 90301, United States

    Contact Email: •••••@•••••

  • Research Site 13

    RECRUITING

    Bakersfield, California, 93301, United States

    Contact Email: •••••@•••••

  • Research Site 14

    RECRUITING

    Shinagawa-Ku, Tokyo, 140-8522, Japan

    Contact Email: •••••@•••••

  • Research Site 15

    RECRUITING

    Fukuoka, Tukuoka, 812-0054, Japan

    Contact Email: •••••@•••••

  • Research Site 16

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

    Contact Email: •••••@•••••

  • Research Site 17

    RECRUITING

    San Antonio, Texas, 78258, United States

    Contact Email: •••••@•••••

  • Research Site 18

    RECRUITING

    High Wycombe, Buckinghamshire, HP11 2QW, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 19

    RECRUITING

    Belgrade, Belgrade, 11070, Serbia

    Contact Email: •••••@•••••

  • Research Site 20

    RECRUITING

    Fall River, Massachusetts, 02723, United States

    Contact Email: •••••@•••••

  • Research Site 21

    RECRUITING

    Oklahoma City, Oklahoma, 73118, United States

    Contact Email: •••••@•••••

  • Research Site 22

    RECRUITING

    Mechelen, Vlaams Brabant, 02800, Belgium

    Contact Email: •••••@•••••

  • Research Site 23

    RECRUITING

    Matsuyama, Ehime, 790-092, Japan

    Contact Email: •••••@•••••

  • Research Site 24

    RECRUITING

    Rotherham, England, S61 1AH, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 25

    RECRUITING

    Thetford, England, IP24 1JD, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 26

    RECRUITING

    London, Greater London, W1T 6AH, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 27

    RECRUITING

    Nottingham, Nottinghamshire, NG7 2QW, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 28

    RECRUITING

    Bristol, England, BS8 2RA, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 29

    RECRUITING

    Romford, England, RM13PJ, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 30

    RECRUITING

    London, England, N12 8BU, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 31

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

    Contact Email: •••••@•••••

  • Research Site 32

    RECRUITING

    Fukui-shi, Fukui, 910-0846, Japan

    Contact Email: •••••@•••••

  • Research Site 33

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

    Contact Email: •••••@•••••

  • Research Site 34

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

    Contact Email: •••••@•••••

  • Research Site 35

    RECRUITING

    Spišská Nová Ves, Slovakia, 05201, Slovakia

    Contact Email: •••••@•••••

  • Research Site 36

    RECRUITING

    Košice, 04013, Slovakia

    Contact Email: •••••@•••••

  • Research Site 37

    RECRUITING

    Isesaki-Shi, Gunma, 372-0831, Japan

    Contact Email: •••••@•••••

  • Research Site 38

    RECRUITING

    Ube, Yamaguchi, 755-8505, Japan

    Contact Email: •••••@•••••

  • Research Site 41

    RECRUITING

    Himeji, Hyōgo, 670-0849, Japan

    Contact Email: •••••@•••••

  • Research Site 42

    RECRUITING

    Sakai, Osaka, 590-0132, Japan

    Contact Email: •••••@•••••

  • Research Site 43

    RECRUITING

    Yokohama, Kanagawa, 223-0053, Japan

    Contact Email: •••••@•••••

  • Research Site 44

    RECRUITING

    Kyiv, Kyïvs'ka Oblast, 02002, Ukraine

    Contact Email: •••••@•••••

  • Research Site 45

    RECRUITING

    Erpent, 5101, Belgium

    Contact Email: •••••@•••••

  • Research Site 46

    RECRUITING

    Kiyose-shi, Tokyo, 204-0022, Japan

    Contact Email: •••••@•••••

  • Research Site 47

    RECRUITING

    Niigata, Niigata, 950-1197, Japan

    Contact Email: •••••@•••••

  • Research Site 48

    RECRUITING

    Plymouth, PL66PH, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 49

    RECRUITING

    Chernivtsi, Chernivtsi Oblast, 58001, Ukraine

    Contact Email: •••••@•••••

  • Research Site 50

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21050, Ukraine

    Contact Email: •••••@•••••

  • Research Site 51

    RECRUITING

    Belgrade, 11000, Serbia

    Contact Email: •••••@•••••

  • Research Site 52

    RECRUITING

    Kyiv, Kyivs'ka Oblast, 01135, Ukraine

    Contact Email: •••••@•••••

  • Research Site 53

    RECRUITING

    Brest, Finistère, 29000, France

    Contact Email: •••••@•••••

  • Research Site 54

    RECRUITING

    Chuo Ku, Tokyo, 104-8560, Japan

    Contact Email: •••••@•••••

  • Research Site 55

    RECRUITING

    Ebino, Miyazaki, 889-4304, Japan

    Contact Email: •••••@•••••

  • Research Site 56

    RECRUITING

    Kamenitz, 21204, Serbia

    Contact Email: •••••@•••••

  • Research Site 57

    RECRUITING

    Belgrade, Belgrade, 11080, Serbia

    Contact Email: •••••@•••••

  • Research Site 58

    RECRUITING

    Belgrade, Belgrade, 11000, Serbia

    Contact Email: •••••@•••••

  • Research Site 59

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

    Contact Email: •••••@•••••

  • Research Site 60

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

    Contact Email: •••••@•••••

  • Research Site 61

    RECRUITING

    Vinnytsia, Vinnytsya, 21018, Ukraine

    Contact Email: •••••@•••••

  • Research Site 62

    RECRUITING

    London, Westminster, SW1P2PF, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 63

    RECRUITING

    Uruma, Okinawa, 904-2293, Japan

    Contact Email: •••••@•••••

  • Research Site 64

    RECRUITING

    Lutsk, Volyn Oblast, 43005, Ukraine

    Contact Email: •••••@•••••

  • Research Site 65

    RECRUITING

    Lancaster, California, 93534, United States

    Contact Email: •••••@•••••

  • Research Site 66

    RECRUITING

    Itabashi-ku, Tokyo, 173-8610, Japan

    Contact Email: •••••@•••••

  • Research Site 67

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1426AKD, Argentina

    Contact Email: •••••@•••••

  • Research Site 68

    RECRUITING

    Seto-shi, Aiti, 489-0065, Japan

    Contact Email: •••••@•••••

  • Research Site 69

    RECRUITING

    New York, New York, 10016, United States

  • Research Site 69

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Research Site 70

    RECRUITING

    Metropolitan Borough of Wirral, Wirral, CH48 5AA, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 71

    RECRUITING

    Zaragoza, Zaragoza, 50009, Spain

    Contact Email: •••••@•••••

  • Research Site 72

    RECRUITING

    Coffs Harbour, New South Wales, 2450, Australia

    Contact Email: •••••@•••••

  • Research Site 73

    RECRUITING

    Mechelen, Vlaams Brabant, 2800, Belgium

    Contact Email: •••••@•••••

  • Research Site 74

    RECRUITING

    Kyiv, Kyïvs'ka Oblast, 3151, Ukraine

    Contact Email: •••••@•••••

  • Research Site 75

    RECRUITING

    Hachioji-Shi, Tokyo, 193-0944, Japan

    Contact Email: •••••@•••••

  • Research Site 76

    RECRUITING

    Kyiv, Kyïvs'ka Oblast, 3049, Ukraine

    Contact Email: •••••@•••••

  • Research Site 77

    RECRUITING

    Trabzon, Trabzon, 61080, Turkey (Türkiye)

    Contact Email: •••••@•••••

  • Research Site 78

    RECRUITING

    Antalya, 7070, Turkey (Türkiye)

    Contact Email: •••••@•••••

  • Research Site 79

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina

    Contact Email: •••••@•••••

  • Research Site 80

    RECRUITING

    Mendoza, Mendoza Province, 5519, Argentina

    Contact Email: •••••@•••••

  • Research Site 81

    RECRUITING

    Concepción del Uruguay, Entre Ríos Province, 3260, Argentina

    Contact Email: •••••@•••••

  • Research Site 82

    RECRUITING

    Kyiv, Kyïvs'ka Oblast, 3038, Ukraine

    Contact Email: •••••@•••••

  • Research Site 83

    RECRUITING

    Vinnytsia, Vinnytsya, 21001, Ukraine

    Contact Email: •••••@•••••

  • Research Site 84

    RECRUITING

    Somerton, Somerset, TA11 7PB, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 85

    RECRUITING

    Honiton, EX14 2NY, United Kingdom

    Contact Email: •••••@•••••

  • Research Site 86

    RECRUITING

    Toshima-Ku, Tokyo, 171-0014, Japan

    Contact Email: •••••@•••••

  • Research Site 87

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1023AAB, Argentina

    Contact Email: •••••@•••••

  • Research Site 89

    RECRUITING

    Novi Sad, 21000, Serbia

    Contact Email: •••••@•••••

  • Research Site 91

    RECRUITING

    Ivano-Frankivsk, Ivano-Frankivs'k, 76008, Ukraine

    Contact Email: •••••@•••••

  • Research Site 92

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425FVH, Argentina

    Contact Email: •••••@•••••

  • Research Site 93

    RECRUITING

    Ankara, Ankara, 6230, Turkey (Türkiye)

    Contact Email: •••••@•••••

  • Research Site 95

    RECRUITING

    Tartu, Tartu, 50106, Estonia

    Contact Email: •••••@•••••

  • Research Site 99

    RECRUITING

    Trieste, Friuli Venezia Giulia, 34149, Italy

    Contact Email: •••••@•••••

  • Research site 39

    RECRUITING

    Southport, Queensland, 4222, Australia

    Contact Email: •••••@•••••

  • Research site 40

    RECRUITING

    Chuo Ku, Tokyo, 103-0027, Japan

    Contact Email: •••••@•••••

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