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Cure My Disease

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New asthma drug could cut attacks with just two shots a year

NCT ID NCT07276724

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10 times

Summary

This phase 3 trial tests whether GB-0895, given every 6 months, can reduce asthma attacks in adults and teens (ages 12–80) with severe asthma that isn't controlled by standard inhalers. About 786 participants will receive either GB-0895 or a placebo, and researchers will track how many asthma attacks occur over 52 weeks. The goal is to see if this treatment can help people breathe easier and need fewer emergency treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GB-0895
What this could lead to
If it works, this could provide a new treatment option that reduces asthma attacks with dosing only every 6 months, improving control for people with severe asthma.
What could go wrong
This is still an experimental drug, and results may not show a significant benefit over placebo. Side effects or lack of efficacy could limit its use.

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

Dec 2025

Expected to finish

Dec 2028

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 11 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 Site 01

    RECRUITING

    Miami Lakes, Florida, 33014, United States

    Contact Email: •••••@•••••

  • Research Site 02

    RECRUITING

    Tampa, Florida, 33613, United States

    Contact Email: •••••@•••••

  • Research Site 03

    RECRUITING

    Hialeah, Florida, 33016, United States

    Contact Email: •••••@•••••

  • Research Site 04

    RECRUITING

    Miami, Florida, 33126, United States

    Contact Email: •••••@•••••

  • Research Site 05

    RECRUITING

    Lewisville, Texas, 75057, United States

    Contact Email: •••••@•••••

  • Research Site 06

    RECRUITING

    Flint, Michigan, 48504, United States

    Contact Email: •••••@•••••

  • Research Site 07

    RECRUITING

    Dallas, Texas, 75230, United States

    Contact Email: •••••@•••••

  • Research Site 08

    RECRUITING

    North Miami, Florida, 33169, United States

    Contact Email: •••••@•••••

  • Research Site 09

    RECRUITING

    Houston, Texas, 77099, United States

    Contact Email: •••••@•••••

  • Research Site 10

    RECRUITING

    Palm Springs, Florida, 33461, United States

    Contact Email: •••••@•••••

  • Research Site 11

    RECRUITING

    Houston, Texas, 77084, United States

    Contact Email: •••••@•••••

  • Research Site 12

    RECRUITING

    Doral, Florida, 33122, United States

    Contact Email: •••••@•••••

  • Research Site 13

    RECRUITING

    West Hills, California, 91307, United States

    Contact Email: •••••@•••••

  • Research Site 14

    RECRUITING

    Gainesville, Florida, 32607, United States

    Contact Email: •••••@•••••

  • Research Site 15

    RECRUITING

    Colorado Springs, Colorado, 80923, United States

    Contact Email: •••••@•••••

  • Research Site 16

    RECRUITING

    Baltimore, Maryland, 21237, United States

    Contact Email: •••••@•••••

  • Research Site 17

    RECRUITING

    Dallas, Texas, 75254, United States

    Contact Email: •••••@•••••

  • Research Site 18

    RECRUITING

    Rincon, Georgia, 31326, United States

    Contact Email: •••••@•••••

  • Research Site 19

    RECRUITING

    Baytown, Texas, 77521, United States

    Contact Email: •••••@•••••

  • Research Site 20

    RECRUITING

    Towson, Maryland, 21204, United States

    Contact Email: •••••@•••••

  • Research Site 21

    RECRUITING

    Riverton, Utah, 84096, United States

    Contact Email: •••••@•••••

  • Research Site 22

    RECRUITING

    Kerrville, Texas, 78028, United States

    Contact Email: •••••@•••••

  • Research Site 23

    RECRUITING

    Northridge, California, 91324, United States

    Contact Email: •••••@•••••

  • Research Site 24

    RECRUITING

    Amarillo, Texas, 79106, United States

    Contact Email: •••••@•••••

  • Research Site 25

    RECRUITING

    Kendall, Florida, 33176, United States

    Contact Email: •••••@•••••

  • Research Site 26

    RECRUITING

    Pasadena, California, 91105, United States

    Contact Email: •••••@•••••

  • Research Site 27

    RECRUITING

    Gastonia, North Carolina, 28054, United States

    Contact Email: •••••@•••••

  • Research Site 28

    RECRUITING

    Columbia, Maryland, 21045, United States

    Contact Email: •••••@•••••

  • Research Site 29

    RECRUITING

    Rancho Cucamonga, California, 91730, United States

    Contact Email: •••••@•••••

  • Research Site 30

    RECRUITING

    Olive Branch, Mississippi, 38654, United States

    Contact Email: •••••@•••••

  • Research Site 31

    RECRUITING

    Glenview, Illinois, 60026, United States

    Contact Email: •••••@•••••

  • Research Site 32

    RECRUITING

    Brooksville, Florida, 34613, United States

    Contact Email: •••••@•••••

  • Research Site 33

    RECRUITING

    McKinney, Texas, 75069, United States

    Contact Email: •••••@•••••

  • Research Site 34

    RECRUITING

    Valencia, California, 91355, United States

    Contact Email: •••••@•••••

  • Research Site 35

    RECRUITING

    Bucharest, Bucharest, 061692, Romania

    Contact Email: •••••@•••••

  • Research Site 36

    RECRUITING

    Frankfurt am Main, Hesse, 60596, Germany

    Contact Email: •••••@•••••

  • Research Site 37

    RECRUITING

    The Bronx, New York, 10461, United States

    Contact Email: •••••@•••••

  • Research Site 38

    RECRUITING

    Kozloduy, Vratsa, 3320, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 39

    RECRUITING

    Vidin, Vidin, 3703, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 40

    RECRUITING

    Berlin, State of Berlin, 10119, Germany

    Contact Email: •••••@•••••

  • Research Site 40

    RECRUITING

    Berlin, 10119, Germany

    Contact Email: •••••@•••••

  • Research Site 41

    RECRUITING

    Oradea, Bihor County, 410163, Romania

    Contact Email: •••••@•••••

  • Research Site 42

    RECRUITING

    Deggingen, Baden-Wurttemberg, 73326, Germany

    Contact Email: •••••@•••••

  • Research Site 43

    RECRUITING

    Lübeck, Schleswig-Holstein, 23552, Germany

    Contact Email: •••••@•••••

  • Research Site 43

    RECRUITING

    Lübeck, Germany

    Contact Email: •••••@•••••

  • Research Site 44

    RECRUITING

    Berlin, State of Berlin, 10717, Germany

    Contact Email: •••••@•••••

  • Research Site 45

    RECRUITING

    Budapest, Budapest, 1047, Hungary

    Contact Email: •••••@•••••

  • Research Site 46

    RECRUITING

    Szombathely, Vas County, 9700, Hungary

    Contact Email: •••••@•••••

  • Research Site 47

    RECRUITING

    Mosonmagyaróvár, Győr-Moson-Sopron, 9200, Hungary

    Contact Email: •••••@•••••

  • Research Site 48

    RECRUITING

    Figueira da Foz Municipality, Figueira da Foz, 3094-001, Portugal

    Contact Email: •••••@•••••

  • Research Site 49

    RECRUITING

    Berlin, State of Berlin, 13187, Germany

    Contact Email: •••••@•••••

  • Research Site 50

    RECRUITING

    Brasov, Brașov County, 500051, Romania

    Contact Email: •••••@•••••

  • Research Site 51

    RECRUITING

    Craiova, Dolj, 200678, Romania

    Contact Email: •••••@•••••

  • Research Site 52

    RECRUITING

    Riga, Riga, LV-1002, Latvia

    Contact Email: •••••@•••••

  • Research Site 53

    RECRUITING

    Szigetvár, Baranya Varmegye, 7900, Hungary

    Contact Email: •••••@•••••

  • Research Site 54

    RECRUITING

    Pleven, Pleven, 5800, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 55

    RECRUITING

    Plovdiv, Plovdiv, 4023, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 56

    RECRUITING

    Haskovo, Haskovo, 6300, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 57

    RECRUITING

    Sydenham, KwaZulu-Natal, 4091, South Africa

    Contact Email: •••••@•••••

  • Research Site 58

    RECRUITING

    Durban, KwaZulu-Natal, 4092, South Africa

    Contact Email: •••••@•••••

  • Research Site 59

    RECRUITING

    Johannesburg, Gauteng, 2001, South Africa

    Contact Email: •••••@•••••

  • Research Site 60

    RECRUITING

    KwaDukuza, Gauteng, 4449, South Africa

    Contact Email: •••••@•••••

  • Research Site 61

    RECRUITING

    Welkom, Free State, 9460, South Africa

    Contact Email: •••••@•••••

  • Research Site 62

    RECRUITING

    Heerlen, Limburg, 6419PC, Netherlands

    Contact Email: •••••@•••••

  • Research Site 63

    RECRUITING

    Sofia, Sofia, 1756, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 64

    RECRUITING

    Cluj-Napoca, Cluj, 400371, Romania

    Contact Email: •••••@•••••

  • Research Site 65

    RECRUITING

    Sofia, Sofia, 1407, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 66

    RECRUITING

    Cluj-Napoca, Cluj, 400332, Romania

    Contact Email: •••••@•••••

  • Research Site 67

    RECRUITING

    Frankfurt am Main, Hesse, 60389, Germany

    Contact Email: •••••@•••••

  • Research Site 68

    RECRUITING

    Cape Town, Western Cape, 7530, South Africa

    Contact Email: •••••@•••••

  • Research Site 69

    RECRUITING

    Sofia, Sofia, 1680, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 70

    RECRUITING

    Riga, Riga, LV-1010, Latvia

    Contact Email: •••••@•••••

  • Research Site 71

    RECRUITING

    Riga, Riga, LV-1004, Latvia

    Contact Email: •••••@•••••

  • Research Site 72

    RECRUITING

    Timișoara, Timiș County, 300310, Romania

    Contact Email: •••••@•••••

  • Research Site 73

    RECRUITING

    Rousse, Ruse, 7002, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 74

    RECRUITING

    Porto, Senhora Da Hora, 4464-513, Portugal

    Contact Email: •••••@•••••

  • Research Site 75

    RECRUITING

    Sofia, Sofia, 1404, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 76

    RECRUITING

    Witten, North Rhine-Westphalia, 58452 Witten, Germany

    Contact Email: •••••@•••••

  • Research Site 77

    RECRUITING

    Enschede, Overijssel, 7512 AV, Netherlands

    Contact Email: •••••@•••••

  • Research Site 78

    RECRUITING

    Szombathely, Vas County, H-9700, Hungary

    Contact Email: •••••@•••••

  • Research Site 80

    RECRUITING

    München, Bavaria, 81241, Germany

    Contact Email: •••••@•••••

  • Research Site 81

    RECRUITING

    Sofia, Sofia, 1680, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 82

    RECRUITING

    Thessaloniki, Exochi, 57010, Greece

    Contact Email: •••••@•••••

  • Research Site 83

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

    Contact Email: •••••@•••••

  • Research Site 84

    RECRUITING

    Bucharest, Bucharest, 11658, Romania

    Contact Email: •••••@•••••

  • Research Site 85

    RECRUITING

    Varnsdorf, Czechia, 407 47, Czechia

    Contact Email: •••••@•••••

  • Research Site 86

    RECRUITING

    Jablonec nad Nisou, 466 01, Czechia

    Contact Email: •••••@•••••

  • Research Site 87

    RECRUITING

    Cluj-Napoca, Cluj, 400006, Romania

    Contact Email: •••••@•••••

  • Research Site 88

    RECRUITING

    Rousse, Ruse, 7002, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 89

    RECRUITING

    Johannesburg, Gauteng, 1820, South Africa

    Contact Email: •••••@•••••

  • Research Site 90

    RECRUITING

    Athens, Attica, 11521, Greece

    Contact Email: •••••@•••••

  • Research Site 91

    RECRUITING

    Sofia, Sofia, 1431, Bulgaria

    Contact Email: •••••@•••••

  • Research Site 92

    RECRUITING

    Leipzig, 04347, Germany

    Contact Email: •••••@•••••

  • Research Site 94

    RECRUITING

    Teplice, 415 01, Czechia

    Contact Email: •••••@•••••

  • Research Site 95

    RECRUITING

    Sofia, Sofia, 1233, Bulgaria

    Contact Email: •••••@•••••

  • Research site 79

    RECRUITING

    Leipzig, Saxony, 4299, Germany

    Contact Email: •••••@•••••

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