GB-0895 for Asthma

Recruiting at 10 trial locations

Overseen By Generate Recruitment

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Generate Biomedicines

Must be taking: Inhaled corticosteroids, Asthma controllers

Must not be taking: Anti-IL-5, Anti-TSLP

Disqualifiers: Respiratory disease, Cancer, Smoking, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 52 weeks

786 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GB-0895 to determine its effectiveness in improving health for people with severe asthma that isn't well-controlled by standard inhalers and other asthma medications. Participants will receive either the GB-0895 treatment or a placebo every six months over a year. The trial seeks individuals who have had asthma for at least two years, are on medium to high doses of inhaled corticosteroids, and have experienced at least two severe asthma attacks in the past year despite treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in asthma treatment.

Is there any evidence suggesting that GB-0895 is likely to be safe for humans?

Research has shown that GB-0895 was safe in earlier studies. People with mild to moderate asthma responded well to the treatment, even at different doses, and no major safety issues emerged. Additionally, GB-0895 demonstrated long-lasting effects, supporting its use as a treatment every six months. For those considering joining a trial, this information suggests that GB-0895 is generally safe based on past research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Most treatments for asthma, like inhaled corticosteroids and bronchodilators, work by reducing inflammation or relaxing airway muscles. But GB-0895 is unique because it targets a different mechanism: it’s administered via subcutaneous injection, which could potentially offer a more direct and sustained effect. Researchers are excited about GB-0895 because it might improve asthma control for patients who don't respond well to current inhaled therapies. This new delivery method could provide a more convenient option for managing asthma symptoms effectively.

What evidence suggests that GB-0895 might be an effective treatment for severe asthma?

Research has shown that GB-0895, a special type of medication, may help treat severe asthma. Earlier studies found that people with mild to moderate asthma tolerated GB-0895 well, and it provided long-lasting effects. This trial will test GB-0895's ability to reduce asthma attacks, particularly for those who don't get enough relief from inhaled steroids. The medication remains in the body for about 89 days, allowing patients to take it only twice a year, which is convenient. Advanced methods used in its production might enhance its effectiveness in managing severe asthma symptoms. Overall, early evidence suggests that GB-0895 could be a promising option for people with severe, uncontrolled asthma. ^{3 5 6 7 8}

Who Is on the Research Team?

Snodgres

Principal Investigator

Generate Biomedicines

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 12 and 80 years old.

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

ACQ-6 score of 1.5 or higher at the Screening Visit

Exclusion Criteria

I have had cancer within the past 5 years or currently have cancer.

I do not have serious liver disease and have not had certain recent treatments or vaccines.

Unwillingness or inability to adhere to study procedures

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants undergo a run-in period to stabilize their condition before randomization

4 weeks

1 visit (in-person)

Treatment

Participants receive either GB-0895 or placebo administered subcutaneously every 6 months

52 weeks

Visits every 1-2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

38 weeks

Regular follow-up visits

Open-label extension (optional)

Participants may opt into continuation of GB-0895 treatment long-term

90 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GB-0895

How Is the Trial Designed?

Group I: GB-0895 Experimental Treatment 1 Intervention

GB-0895 Subcutaneous (SC) injection

Group II: Placebo Placebo Group 1 Intervention

Placebo Subcutaneous (SC) injection

Who Is Running the Clinical Trial?

Generate Biomedicines

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07116889

NCT07116889 | A Study to Investigate GB-0895 in Adults ...

The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

2.

cdn.generatebiomedicines.com

cdn.generatebiomedicines.com/assets/ERS-2025-Late-Breaker-Presentation.pdf

GB-0895, a high-affinity anti-TSLP mAb, demonstrates ...

▫ These data support dosing of GB-0895 subcutaneously every 6-months for severe asthma. PHASE 3 TRIALS OF GB-0895 EXPECTED TO INITIATE IN Q4 2025.

3.

prnewswire.com

prnewswire.com/news-releases/generatebiomedicines-to-initiate-global-phase-3-studies-of-gb-0895-a-long-acting-anti-tslp-antibody-for-severe-asthma-engineered-with-ai-302628189.html

Generate:Biomedicines to Initiate Global Phase 3 Studies ...

These studies will evaluate the efficacy of GB-0895 in reducing clinically significant asthma exacerbations over 52 weeks, the primary objective ...

4.

firstwordpharma.com

firstwordpharma.com/story/6107993

Generate:Biomedicines to Present Phase 1 Results for AI- ...

GB-0895 was well tolerated across a wide dose range of 10 mg to 1200 mg and demonstrated dose-proportional pharmacokinetics with a prolonged ...

5.

withpower.com

withpower.com/trial/phase-3-asthma-11-2025-4316c

GB-0895 for Asthma · Info for Participants

In previous studies, people with mild to moderate asthma tolerated GB-0895 well, even at different doses. The treatment also had long-lasting effects, ...

6.

publications.ersnet.org

publications.ersnet.org/content/erj/66/suppl69/oa2332

Late Breaking Abstract - GB-0895, a high-affinity anti-TSLP ...

A single dose of GB-0895 drives PD biomarker suppression for at least 6 months, reflecting the broad anti-inflammatory effects of the anti-TSLP mechanism seen ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07359846

NCT07359846 | A Study to Investigate GB-0895 Adjunctive ...

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 ...

8.

healio.com

healio.com/news/allergy-asthma/20251014/monoclonal-antibody-effects-persist-for-6-months-in-patients

Monoclonal antibody effects persist for 6 months in patients

GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing ...