Recent Updates
Recently added Catalysts

GB001

Phase 2

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Small molecule | ENT |Gossamer Bio, Inc.|Last Updated: Sep 16, 2021

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical trial landscape

GB001 · 2 trials · 3 indications

Phase 2 2
NCT03956862GB001 in Adult Participants With Chronic RhinosinusitisChronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
COMPLETED97 Analytics
NCT03683576GB001 in Adult Subjects With Moderate to Severe AsthmaAsthma
COMPLETED481 Analytics
PHASE2COMPLETED
GB001 in Adult Participants With Chronic Rhinosinusitis
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Unlock trial analytics
PHASE2COMPLETED
GB001 in Adult Subjects With Moderate to Severe Asthma
AsthmaUnlock trial analytics
Study Endpoints
Primary Endpoints
Change From Baseline to Week 16 in Sino-Nasal Outcome Test (SNOT) 22 Total Score
Baseline, Week 16

The SNOT-22 is a validated questionnaire to assess the impact of chronic rhinosinusitis (CRS) on quality of life and utilizes a 2-week recall period. It is a 22-item outcome measure on a 5-point category scale applicable to sinonasal conditions and surgical treatments. The total scores range from 0 to 110 with higher total scores implying greater impact of CRS on quality of life.

Proportion of Participants Who Experience Worsening of Asthma by Week 24
up to Week 24

Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.

Secondary Endpoints
Change From Baseline to Week 16 in Lund-Mackay Score
Baseline, Week 16
Change From Baseline to Week 16 in Nasal Polyp Score (NPS)
Baseline, Week 16
Time to First Response in NPS
up to Week 16
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GB001EXPERIMENTALGB001 40 mg once per day (QD) for 16 weeks
PlaceboPLACEBO_COMPARATORPlacebo QD for 16 weeks
GB001 20 mgEXPERIMENTALGB001 20 mg QD for 24 weeks
GB001 40 mgEXPERIMENTALGB001 40 mg QD for 24 weeks
GB001 60 mgEXPERIMENTALGB001 60 mg QD for 24 weeks
Interventions
NameTypeDescription
GB001DRUGfilm-coated oral tablet
PlaceboDRUGfilm-coated oral tablet
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit * Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visi...

Countries:United StatesCzechiaUkraineAustriaBelgiumCanadaFranceGermanyPolandSpainUnited Kingdom
Unlock Eligibility Criteria