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FF/UMEC/VI

Phase 3

Asthma | Small molecule | Respiratory |Grace Therapeutics, Inc.|Last Updated: Aug 29, 2025

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical trial landscape

FF/UMEC/VI · 1 trial · 1 indication

Phase 3 1
NCT04651777Evaluation of Triple Therapy Using Magnetic Resonance Imaging in AsthmaAsthma
ACTIVE NOT_RECRUITING31 Analytics
PHASE3ACTIVE NOT_RECRUITING
Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma
Asthma
NCT0465177731
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Study Endpoints
Primary Endpoints
Change From Baseline Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily
Day 0 to day 42

Change in VDP

Secondary Endpoints
Change From Baseline Forced Expiration Volume in One Second
Baseline and Day 42
Change From Baseline Forced Vital Capacity
Baseline and Day 42
Change From Baseline Residual Volume
Baseline and Day 42
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants with poorly controlled moderate to severe asthmaEXPERIMENTALParticipants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
Interventions
NameTypeDescription
FF/UMEC/VIDRUGThe investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol. The drug is delivered in an Ellipta inhaler in a single dose once daily.
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature * Provision of written, informed consent prior to any study specific procedures * Males and females with a clinical diagnosis of eosinophilic asthma ...

Countries:Canada
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Competitive Landscape -Asthma 77 trials
CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate / Fluticasone Propionate, Run-In Medication
AstraZeneca PLCAZN28PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Upstream Bio, Inc.UPB1PHASE2Verekitug
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
Unity Health TorontoUBX1N/AUndisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04651777primaryCompletionDate: changed
LOWMay 24, 2026NCT04651777studyFirstPostDate: changed