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QAX576

Phase 2

Allergic Rhinitis | Small molecule | Respiratory |Novartis AG|Trials Updated: Mar 11, 2021

QAX576 development status

Highest phase Phase 2
Registered trials 12 across 2 sponsors since Dec 2006

QAX576 target and mechanism

Molecular targetIL13
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials6
Total Enrollment412

FDA Designations

No designations recorded

QAX576 clinical trials

QAX576 · 6 trials · 5 indications

Phase 2 5Phase 1 1
NCT01355614A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsCrohn's Disease
COMPLETED10 Analytics
NCT01130064Efficacy of QAX576 in AsthmaAsthma
COMPLETED259 Analytics
NCT01022970Efficacy and Safety of QAX576 in Patients With Eosinophilic EsophagitisEosinophilic Esophagitis
COMPLETED25 Analytics
NCT00584584An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated HayfeverAllergic Rhinitis
COMPLETED36 Analytics
NCT00532233SD, IL-13 Production Rate in IPFIdiopathic Pulmonary Fibrosis
COMPLETED52 Analytics
PHASE2COMPLETED
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients
Crohn's DiseaseUnlock trial analytics
PHASE2COMPLETED
Efficacy of QAX576 in Asthma
AsthmaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis
Eosinophilic EsophagitisUnlock trial analytics
PHASE2COMPLETED
An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
Allergic RhinitisUnlock trial analytics
PHASE2COMPLETED
SD, IL-13 Production Rate in IPF
Idiopathic Pulmonary FibrosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation
52 weeks
Asthma Control Questionnaire
24 weeks
The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13.
13 weeks
Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
throughout the study
-To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF
Week 1,2,3 and 4
Measure: Assessing and comparing the safety and tolerability of multiple doses of QAX576 in controlled and partially controlled asthma patients.
120 Days

Secondary Endpoints

Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc
52 weeks
Incidence rate of clinically significant asthma exacerbations
24 weeks
To ascertain the effect of QAX576 in the frequency and severity of the symptoms of EoE.
34 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QAX576EXPERIMENTAL -
InfliximabOTHER -
PlaceboPLACEBO_COMPARATORPlacebo
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
QAX576 1 mg/kgACTIVE_COMPARATOR -
QAX576 3 mg/kgACTIVE_COMPARATOR -
QAX576 10 mg/kgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
QAX576DRUG -
InfliximabDRUG -
PlaceboDRUGevery 3 weeks via intravenous infusion
QAX576 placeboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * At least one draining enterocutaneous perianal fistula * Diagnosis of Crohn's disease (CD) must have been established for at least 6 months * At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment) * Patients ...

Countries:GermanySwitzerlandUnited StatesArgentinaBelgiumCzechiaPolandRussiaUnited Kingdom
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Competitive Landscape -Allergic Rhinitis 8 trials

Top 1 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150
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Frequently asked questions about QAX576

What is QAX576?

QAX576 is an investigational small molecule developed by Novartis AG for respiratory and immune-related conditions. It has been studied in allergic rhinitis, asthma, Crohn's disease, eosinophilic esophagitis, and idiopathic pulmonary fibrosis. It is an IL13 inhibitor that has completed Phase 2 clinical testing.

What does QAX576 target?

QAX576 targets IL13, an inflammatory cytokine also known as interleukin-13. As an IL13 inhibitor, QAX576 is designed to block the activity of this signaling protein, which is involved in allergic and eosinophilic inflammatory responses. This mechanism underlies its study in asthma, eosinophilic esophagitis, and related conditions.

Who makes QAX576?

QAX576 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trial program evaluating the compound across multiple inflammatory and respiratory indications, including asthma, Crohn's disease, and eosinophilic esophagitis.

What phase is QAX576 in?

QAX576 has completed Phase 2 clinical development. It is an investigational agent and is not described as approved for any indication. The Phase 2 program covered asthma, Crohn's disease, and eosinophilic esophagitis, with a Phase 1 study also completed in asthma patients.

What clinical trials is QAX576 in?

QAX576 has been evaluated in completed trials including NCT01130064 in asthma, NCT01355614 in fistulizing Crohn's disease, NCT01022970 in eosinophilic esophagitis, and NCT00940160, a Phase 1 asthma study. These trials enrolled a combined total of 324 participants across the United States, Europe, Russia, and Argentina.

Is QAX576 FDA approved?

QAX576 is not described as approved and remains an investigational drug that has completed Phase 2 testing. Its trials were randomized, double-blind, and placebo-controlled, but no regulatory approval for any indication is stated. Development status should be confirmed through current regulatory filings.