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Mitizax

Phase 3

Allergy | Small molecule | Immunology |Abbott Laboratories|Last Updated: Mar 1, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

Mitizax · 1 trial · 3 indications

Phase 3 1
NCT02596321A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic AsthmaAllergy
COMPLETED112 Analytics
PHASE3COMPLETED
A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma
AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

D. Farinae Specific IgG4 Change From Baseline to End of Treatment
60 days from baseline

primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment

Secondary Endpoints

D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment
60 days from baseline
D. Farinae Specific IgE Change From Baseline to End of Treatment
60 days from baseline
D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment
60 days from baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mitizax ALK HDM tabletEXPERIMENTALStandardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae developmental unit, dose standard for ALK HDM tablets (12DU)
Placebo tabletPLACEBO_COMPARATORPlacebo tablet

Interventions

NameTypeDescription
MitizaxDRUGAllergen extract
PlaceboDRUGPlacebo tablet
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Written informed consent obtained before entering the study * Patients 18-65 years of age, with a clinical history consistent with HDM-induced allergic rhinitis or allergic rhinoconjunctivitis with or without HDM-induced allergic atopic asthma for more than 1 year * Use of sym...

Countries:BelarusRussia
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Frequently asked questions about Mitizax

What is Mitizax used for?

Mitizax is an investigational small molecule being developed for the treatment of allergy, specifically for allergic rhinitis and atopic asthma induced by house dust mites. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes Mitizax?

Mitizax is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The drug is currently in Phase 3 clinical trials for allergy indications.

What phase is Mitizax in?

Mitizax is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to evaluate its safety and efficacy for treating allergies.

What clinical trials is Mitizax in?

Mitizax has been studied in a Phase 3 clinical trial registered as NCT02596321. This completed trial investigated the immunologic effects and safety of a 60-day treatment in adults with house dust mite-induced allergic rhinitis and/or atopic asthma, enrolling 112 participants in Belarus and Russia.

How does Mitizax work?

Mitizax is a small molecule designed to treat allergies caused by house dust mites. It is being studied for its immunologic effects in patients with allergic rhinitis and atopic asthma, though the specific molecular target has not been disclosed.