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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

NCT07359846 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 786

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GB-0895

Study Drug

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Generate Biomedicines

    lead INDUSTRY

Principal Investigators

  • Snodgres · Generate Biomedicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359846 on ClinicalTrials.gov