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QAV680

Phase 2

Asthma | Small molecule | Respiratory |Novartis AG|Trials Updated: Mar 8, 2017

QAV680 development status

Highest phase Phase 2
Registered trials 3 across 2 sponsors since Nov 2008

QAV680 target and mechanism

Molecular targetPTGDR2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment81

FDA Designations

No designations recorded

QAV680 clinical trials

QAV680 · 2 trials · 2 indications

Phase 2 2
NCT00814216Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma PatientsAsthma
COMPLETED37 Analytics
NCT00784732A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure ChamberSeasonal Allergic Rhinitis
COMPLETED44 Analytics
PHASE2COMPLETED
Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
AsthmaUnlock trial analytics
PHASE2COMPLETED
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Seasonal Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.
2 weeks
Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
TNSS: 6-8h during EEC exposure on Day 10

Secondary Endpoints

Measure: Change in Asthma Control Questionnaire (ACQ) score
2 weeks
Measure: Frequency of salbutamol usage
2 weeks
Measure: Change in exhaled Nitric Oxide (NO)
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QAV680EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Fluticasone Propionate InhalerACTIVE_COMPARATOR -
1EXPERIMENTAL -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
QAV680DRUG -
Matching placebo for QAV680DRUG -
Fluticasone PropionateDRUG -
Mometasone FuroateDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: * Mild to moderate persistent asthma for at least 6 months. Exclusion criteria: * Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C, * Allergic disorders, pancreatic disease...

Countries:GermanyIndiaCanada
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Frequently asked questions about QAV680

What is QAV680?

QAV680 is an investigational small molecule drug developed by Novartis AG for respiratory conditions. It has been studied in Phase 2 clinical trials for asthma and seasonal allergic rhinitis. It is not an approved therapy and remains in clinical development.

What is QAV680 used for?

QAV680 has been evaluated for the treatment of asthma and seasonal allergic rhinitis. Both are respiratory and allergic conditions, and the drug was tested in Phase 2 trials in adults with these diagnoses. It is investigational and not approved for any use.

What does QAV680 target?

QAV680 is a PTGDR2 antagonist. PTGDR2 is a prostaglandin D2 receptor, and QAV680 works by blocking this receptor as a small molecule antagonist. This mechanism is being explored in respiratory and allergic disease settings.

Who makes QAV680?

QAV680 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 clinical trials of QAV680 in asthma and seasonal allergic rhinitis.

What phase is QAV680 in?

QAV680 is in Phase 2 development. It has completed Phase 2 trials in asthma and seasonal allergic rhinitis, and it is not FDA approved. No active trials are currently listed for this asset.

What clinical trials is QAV680 in?

QAV680 has been studied in two completed Phase 2 trials. NCT00814216 evaluated efficacy, safety and pharmacokinetics in 37 asthma patients in Germany and India. NCT00784732 compared QAV680 against placebo in 44 patients with seasonal allergic rhinitis in Canada.