STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Conditions

Hereditary Angioedema

Brief summary

The time-normalized number of Investigator-confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX 324 vs placebo.

Detailed description

The time-normalized number of Investigator-confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants who have not experienced an Investigator-confirmed HAE attack (HAE attack-free) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants who have not experienced an Investigator-confirmed HAE attack (HAE attack-free) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants with a clinical response defined as a reduction from baseline (ie, Screening rate) in Investigator-confirmed HAE attack rate between Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants with a clinical response defined as a reduction from baseline (ie, Screening rate) in Investigator-confirmed HAE attack rate between Study Day 22 to the Week 25 Visit for ADX-324 vs placebo.

Related papers

No related papers found yet.

Interventions

DRUGSterile normal saline (0.9% sodium chloride solution)

DRUGADX-324

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The time-normalized number of Investigator-confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX 324 vs placebo.	—

Secondary

Measure	Time frame
The time-normalized number of Investigator-confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants who have not experienced an Investigator-confirmed HAE attack (HAE attack-free) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of particip	—

Measure

Time frame

The time-normalized number of Investigator-confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The time-normalized number of moderate or severe Investigator confirmed HAE attacks (per month) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of participants who have not experienced an Investigator-confirmed HAE attack (HAE attack-free) from Study Day 22 to the Week 25 Visit for ADX-324 vs placebo., The proportion of particip

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Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed