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PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing GB-0895 for Severe Asthma

The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.

Official registry: https://clinicaltrials.gov/study/NCT07276724 · Generate Biomedicines · enrollment listed as 786

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GB-0895, or Placebo. The registry lists allocation as randomized. The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.

They plan to enroll about 786 people at 153 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: GB-0895, Placebo

Primary outcome (registry wording): To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.

Who it is for (from inclusion criteria)

  • Ages 12 Years to 80 Years
  • Adults and adolescents ≥ 12 and ≤ 80 years of age
  • Documented diagnosis of asthma for \> 12 months
  • 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
  • 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
  • Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \<80% predicted at Screening Visit 1
  • 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
  • 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

Public study contact (from the registry)

Generate Recruitment

888-469-0033

solairiastudy@generatebiomedicines.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

153 listed

+ 116 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07276724 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07276724?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07276724?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary