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QAX028

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Novartis AG|Last Updated: Dec 19, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment62
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01068613Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) PatientsPHASE2 COMPLETED 62Jan 1, 2010Aug 1, 2010Dec 19, 20204 United States
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Study Endpoints
Primary Endpoints
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
7 days treatment
Secondary Endpoints
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
7 days treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QAX028 high doseEXPERIMENTAL -
QAX028 low doseEXPERIMENTAL -
TiotropiumACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
QAX028DRUGQAX028 60 mcg via inhalation device
TiotropiumDRUGTiotropium via inhalation device
PlaceboDRUGPlacebo to QAX028 via inhalation device
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of COPD according to GOLD guidelines * Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7 * Smoking history of at least 10 pack years Exclusion Criteria: * Requiring oxygen therapy on a daily basis * Exacerbation of airway d...

Countries:United States
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