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NCT07359846 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Severe Asthma, sponsored by Generate Biomedicines.

Recruiting
Registry status
Phase 3
Development phase
786
Enrollment target
2
Study locations

NCT07359846 is a Phase 3 study of Severe Asthma that is actively recruiting participants, run by Generate Biomedicines. The registered enrollment target is 786 participants, below the 3,768-participant average among 9 other Severe Asthma trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT07359846, a Phase 3 study of Severe Asthma, is actively recruiting participants, sponsored by Generate Biomedicines.

RECRUITING
Registry status
Phase 3
Development phase
786 participants
Enrollment target
2
Study locations

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 Studied

Severe Asthma

Interventions

  • DRUG Placebo
  • DRUG GB-0895

Study Locations (2)

Florida

  • Research Site 14 - Gainesville
  • Research Site 01 - Tamarac

Trial Details

FieldValue
Enrollment Target 786 participants
Start Date 2026-01-20
Est. Completion 2029-01
Phase Phase 3

Sponsor

Generate Biomedicines

5 total trials

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What the Registry Record Tells You About NCT07359846

The ClinicalTrials.gov registry entry for NCT07359846 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 786 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,768-participant average among 9 other Severe Asthma trials with a reported enrollment target (79% lower). The listed sponsor is Generate Biomedicines, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Severe Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07359846 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT07359846 about?

NCT07359846 is a clinical study titled "A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)". 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 recei...

What is the current status of trial NCT07359846?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 786 participants. The study started on 2026-01-20. Estimated completion is 2029-01.

What conditions does trial NCT07359846 study?

This clinical trial studies the following conditions: Severe Asthma.

What interventions are being tested in trial NCT07359846?

The interventions under investigation include: Placebo (DRUG), GB-0895 (DRUG).

Who is sponsoring clinical trial NCT07359846?

This trial is sponsored by Generate Biomedicines, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07359846 being conducted?

This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.