Why I am expecting some positive news from AZD1419 phase IIa trial result | DVAX Message Board Posts

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Msg  1213 of 1419  at  8/9/2018 11:11:33 PM  by

fairvalueforyou

The following message was updated on 8/10/2018 11:48:39 AM.

Why I am expecting some positive news from AZD1419 phase IIa trial result

    
 
Here are some AZD1419 phase IIA trial descriptions
 
(1). Detailed Description:

Ph2a study planned to be run in approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma.

The study has a withdrawal design.The patients will receive 13 once weekly inhaled doses of the study drug (AZD1419 or placebo). Treatment is initiated with 6 doses of the study drug on top of their ICS/LABA controller medication. Prior to the 7th dose of the study drug the LABA is withdrawn. The following 3 doses are given when ICS is tapered down. Dose 7 is given on top of 100% of their ICS, dose 8 is given on top of 50% of the ICS dose, which is then tapered down to 25% the following week and withdrawn completely prior to dose 10 of the study drug. During the last 3 weeks of treatment (ie last 4 doses), the study drug is given as monotherapy. SABA is used as reliever medication during the whole study period. Primary endpoint is Loss of asthma control, defined as any of the following criteria: a) An increase of ACQ-5 to 1.5 or more b) A reduction of 30% or more in morning peak expiratory flow (PEF) from baseline on 2 consecutive days c) At least six additional reliever inhalations of SABA in a 24-hour period relative to baseline on 2 consecutive days and d) An exacerbation requiring systemic corticosteroids

When the endpoint is met, patients will resume their regular ICS/LABA controller medication and will be followed for an additional 4 weeks, when they do an Early Discontinuation (ED) Visit and will thereafter leave the study. For patients not loosing their asthma control, the full Observational period is up to week 52, when they will do an End of Treatment Visit (EOT). Study procedures are the same on ED and EOT Visits.

 
(2). Primary Outcome Measures : Time to Loss of control [ Time Frame: Up to 52 weeks ]
 
Please note, AZD1419 phase IIA enrollment was completed on 9/21/2017, and the trial is still active today and will be completed by 9/24/2018. Therefore, some participants had/have not met the primary endpoint(loss of asthma control) and continued/continue their once weekly monotherapy AZD1419/placebo inhalation after initial 13 dose treatment. In other words, AZD1419 phase IIA trial would have been finished soon after initial 13 dose treatment period if neither AZD1419 nor placebo worked. Could placebo somehow have worked for some patients up to 52 weeks without asthma medications? Zero chance! And it has to be AZD1419 using its magic to keep some patients to stay in this trial up to 52 weeks without asthma medication. (I want to know how many patients being able to take AZD1419 without asthma medication up to 52 weeks now!)
I could not see any possibility that  AstraZeneca keeps AZD1419 phase IIA trial active for a year after completing its enrollment without participants failing to meet primary endpoint up to 52 weeks
We will know AZD1419 result soon in later September or earlier October, and good luck to all
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Replies
Msg # Subject Author Recs Date Posted
1214 Re: Why I am expecting some positive news from AZD1419 phase IIa trial result liuyiiv 1 8/10/2018 2:54:49 PM
1215 Re: Why I am expecting some positive news from AZD1419 phase IIa trial result liuyiiv 4 8/10/2018 3:56:11 PM


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