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QAX576

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

QAX576 · 7 trials · 6 indications

Phase 2 5Phase 1 2
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
Safety and tolerability of single escalating doses of QAX576 as assessed by vital signs, electrocardiogram (ECG), adverse events, laboratory evaluations, up to 96 hours after drug administration, and telemetry up until 24 hours post dose

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 4 trials

Frequently asked questions about QAX576

What is QAX576 used for?

QAX576 is an investigational small molecule being studied for several conditions, including Crohn's Disease, Eosinophilic Esophagitis, Idiopathic Pulmonary Fibrosis, Asthma, and Allergic Rhinitis. It has been evaluated in clinical trials for these indications, though it is not approved and remains in clinical development.

Who makes QAX576?

QAX576 is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis has sponsored clinical trials of QAX576 across multiple therapeutic areas.

What phase is QAX576 in?

QAX576 has been studied in Phase 2 clinical trials for conditions such as Idiopathic Pulmonary Fibrosis, Allergic Rhinitis, and Crohn's Disease, and in a Phase 1 trial for Asthma. All known trials are completed, and the drug remains investigational.

What clinical trials has QAX576 been in?

QAX576 has been evaluated in several completed trials, including NCT00532233 in Idiopathic Pulmonary Fibrosis, NCT00584584 in Allergic Rhinitis, NCT00940160 in Asthma, and NCT01355614 in fistulizing Crohn's Disease. These trials were placebo-controlled and double-blind.

Is QAX576 the same as an interleukin-13 antibody?

QAX576 is described in a clinical trial title as an interleukin-13 monoclonal antibody, specifically in a study of simulated hayfever. This suggests it targets interleukin-13, though the drug is also classified as a small molecule in other contexts.