A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

Part of paid clinical trials in Northridge, California.

Sponsor
Generate Biomedicines
Study ID
NCT07276724
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
Dec 3, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

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 (34)

FacilityCityStateZIPSite coordinators
Research Site 23NorthridgeCalifornia91324
Research Site 26PasadenaCalifornia91105
Research Site 29Rancho CucamongaCalifornia91730
Research Site 34ValenciaCalifornia91355
Research Site 13West HillsCalifornia91307
Research Site 15Colorado SpringsColorado80923
Research Site 32BrooksvilleFlorida34613
Research Site 12DoralFlorida33122
Research Site 14GainesvilleFlorida32607
Research Site 03HialeahFlorida33016
Research Site 25KendallFlorida33176
Research Site 04MiamiFlorida33126
Research Site 01Miami LakesFlorida33014
Research Site 08North MiamiFlorida33169
Research Site 10Palm SpringsFlorida33461
Research Site 02TampaFlorida33613
Research Site 18RinconGeorgia31326
Research Site 31GlenviewIllinois60026
Research Site 16BaltimoreMaryland21237
Research Site 28ColumbiaMaryland21045
Research Site 20TowsonMaryland21204
Research Site 06FlintMichigan48504
Research Site 30Olive BranchMississippi38654
Research Site 27GastoniaNorth Carolina28054
Research Site 24AmarilloTexas79106
Research Site 19BaytownTexas77521
Research Site 07DallasTexas75230
Research Site 17DallasTexas75254
Research Site 09HoustonTexas77099
Research Site 11HoustonTexas77084
Research Site 22KerrvilleTexas78028
Research Site 05LewisvilleTexas75057
Research Site 33McKinneyTexas75069
Research Site 21RivertonUtah84096

Find similar trials in Northridge, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Research· Northridge, CAResearch· Pasadena, CAResearch· Rancho Cucamonga, CAResearch· Valencia, CAResearch· West Hills, CAResearch· Colorado Springs, CO

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