NCT07359846

Brief Summary

The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks. Visit frequency: every 1-2 months after the first month.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
786

participants targeted

Target at P75+ for phase_3

Timeline
32mo left

Started Jan 2026

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

April 13, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

January 21, 2026

Last Update Submit

April 9, 2026

Conditions

Severe Asthma

Keywords

AsthmaSevere Asthma

Outcome Measures

Primary Outcomes (1)

  • To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.

    The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.

    From Day 1 (randomization) to Week 52

Secondary Outcomes (14)

  • To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.

    From Day 1 (randomization) to Week 52

  • Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    From Day 1 (randomization) to Study Week 52

  • Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score

    From Day 1 (randomization) to Week 52

  • Change from baseline in Asthma Control Questionnaire (ACQ-6) score

    From Day 1 (randomization) to Week 52

  • Time to first asthma exacerbation from randomization

    From Day 1 (randomization) to Week 52

  • +9 more secondary outcomes

Study Arms (2)

GB-0895

EXPERIMENTAL

GB-0895 Subcutaneous (SC) injection

Drug: GB-0895

Placebo

PLACEBO COMPARATOR

Placebo Subcutaneous (SC) injection

Drug: Placebo

Interventions

PlaceboDRUG

Placebo

Placebo
GB-0895DRUG

Study Drug

GB-0895

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.
  • Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).
  • 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.
  • Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
  • A current malignancy or previous history of cancer within 5 years before screening.
  • Clinically significant infection that is not resolved before study enrollment.
  • Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.
  • Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
  • 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.
  • Hepatitis B, C, or HIV.
  • 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.
  • 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.
  • Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.
  • Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site 10

West Covina, California, 91790, United States

RECRUITING

Research Site 06

Miami, Florida, 33126, United States

RECRUITING

Research Site 03

Miami, Florida, 33135, United States

RECRUITING

Research 09

Orlando, Florida, 32807, United States

RECRUITING

Research Site 01

Tamarac, Florida, 33321, United States

RECRUITING

Research Site 04

Tampa, Florida, 33607, United States

RECRUITING

Research Site 05

Tampa, Florida, 33617, United States

RECRUITING

Research Site 02

Ypsilanti, Michigan, 48197, United States

RECRUITING

Research Site 11

Dayton, Ohio, 45424, United States

RECRUITING

Research Site 07

Sugar Land, Texas, 77479, United States

RECRUITING

Research Site 08

Williamsburg, Virginia, 23188, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Snodgres

    Generate Biomedicines

    STUDY DIRECTOR

Central Study Contacts

Generate Recruitment

CONTACT

888-469-0033solairiastudy@generatebiomedicines.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 22, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

April 13, 2026

Record last verified: 2025-12

Locations

US(11)