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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Generate Biomedicines
Study ID
NCT07359846
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • GB-0895 — DRUG
    Study Drug
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
786 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GB-0895
    GB-0895 Subcutaneous (SC) injection
  • Placebo Comparator: Placebo
    Placebo Subcutaneous (SC) injection

Primary Outcome Measure

To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma. [ Time Frame: From Day 1 (randomization) to Week 52 ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Research Site 13BakersfieldCalifornia93301
Research Site 12InglewoodCalifornia90301
Research Site 10West CovinaCalifornia91790
Research Site 03MiamiFlorida33135
Research Site 06MiamiFlorida33126
Research 09OrlandoFlorida32807
Research Site 01TamaracFlorida33321
Research Site 04TampaFlorida33607
Research Site 05TampaFlorida33617
Research Site 02YpsilantiMichigan48197
Research Site 11DaytonOhio45424
Research Site 07Sugar LandTexas77479
Research Site 08WilliamsburgVirginia23188

Find similar trials in Bakersfield, CA

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