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QAV680

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

QAV680 is an investigational small molecule being developed by Novartis for respiratory conditions, specifically seasonal allergic rhinitis and asthma. It has been studied in Phase 2 clinical trials for these indications.

Who makes QAV680?

QAV680 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development.

What phase is QAV680 in?

QAV680 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in seasonal allergic rhinitis and one in asthma. It is not approved and remains investigational.

What clinical trials is QAV680 in?

QAV680 has been studied in two completed Phase 2 trials. NCT00784732 evaluated the drug against placebo in seasonal allergic rhinitis using an environmental exposure chamber in Canada. NCT00814216 assessed efficacy, safety, and pharmacokinetics in asthma patients in Germany and India.

Is QAV680 the same as any other drug?

No alternative names for QAV680 have been reported. The drug is identified solely by its code name QAV680 in clinical trial registries and development records.