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GB-0895 added to usual care for adolescents and adults with severe uncontrolled asthma

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 · NCT07276724

This trial will test whether two subcutaneous doses of GB-0895 given six months apart help teens and adults whose severe asthma remains uncontrolled despite medium-to-high dose 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
Locations27 sites (Northridge, California and 26 other locations)
Trial IDNCT07276724 on ClinicalTrials.gov

What this trial studies

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial enrolling about 786 adolescents and adults with severe uncontrolled asthma. Participants are randomized to receive GB-0895 or placebo by subcutaneous injection at baseline and week 26, with treatment and follow-up extending through 52 weeks and an optional open-label extension. Clinic visits occur roughly every 1–2 months after the first month for safety and efficacy assessments, including lung function and exacerbation monitoring. The trial includes a screening/run-in period before randomization and careful safety monitoring throughout.

Who should consider this trial

Good fit: Ideal candidates are adolescents (≥12 years) and adults up to age 80 with a physician-diagnosed history of asthma ≥2 years, on medium-to-high dose inhaled corticosteroids plus at least one additional controller, with at least two steroid-treated exacerbations in the prior year and documented bronchodilator responsiveness and reduced baseline FEV1 per protocol criteria.

Not a fit: Patients with well-controlled asthma, without recent exacerbations, not on medium-to-high dose ICS plus controller, younger than 12 or older than 80, or who cannot demonstrate the required lung function/bronchodilator response are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, GB-0895 could reduce asthma exacerbations and improve lung function and symptom control when added to standard controller therapy.

How similar studies have performed: Other biologic add-on therapies for severe asthma have shown reduced exacerbations and improved control in Phase 3 trials, but GB-0895 itself is novel and is being tested in this Phase 3 program.

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

Northridge, California and 26 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 2026-06-10 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.