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GB-0895 as an add-on treatment for severe uncontrolled asthma in adolescents and adults

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma

Phase 3 Interventional Generate Biomedicines · NCT07359846

This test tries to see if adding GB-0895 every six months helps adolescents and adults whose severe asthma isn't controlled by inhaled steroids and other controllers.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment786 (estimated)
Ages12 Years to 80 Years
SexAll
SponsorGenerate Biomedicines Industry-sponsored
Drugs / interventionsmepolizumab, reslizumab, benralizumab, depemokimab, tezepelumab, methotrexate
Locations11 sites (West Covina, California and 10 other locations)
Trial IDNCT07359846 on ClinicalTrials.gov

What this trial studies

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial comparing subcutaneous GB-0895 to placebo given at baseline and week 26 over a 52-week treatment period with an optional open-label extension. About 786 participants aged 12–80 with severe asthma uncontrolled on medium-to-high dose inhaled corticosteroids plus at least one additional controller and a history of ≥2 steroid-treated exacerbations in the past year will be enrolled. Participants attend clinic visits every 1–2 months after the first month for safety and efficacy assessments, including lung function and exacerbation monitoring. Safety will be closely monitored and the optional extension allows additional GB-0895 dosing at weeks 52 and 78 for eligible participants.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults (12–80 years) with physician-diagnosed asthma for ≥2 years who remain uncontrolled on medium-to-high dose ICS plus another controller and who have had at least two steroid-treated exacerbations in the past 12 months.

Not a fit: Patients whose asthma is well controlled on current treatment, who lack the required exacerbation or lung-function history, or who cannot attend regular clinic visits or tolerate injections are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GB-0895 could reduce asthma exacerbations and improve control for people with severe asthma who remain uncontrolled on current therapies.

How similar studies have performed: Other biologic add-on therapies for severe asthma (for example anti-IL-5 or anti-IgE agents) have reduced exacerbations in selected patients, but GB-0895 is a novel investigational agent and Phase 3 results are not yet available.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

West Covina, California and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe AsthmaAsthma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.