STOP-HAE: A Phase 3 Study of ADX-324 in HAE
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorADARx Pharmaceuticals, Inc.
About this trial
This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related quality of life measures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years at the time of signing informed consent.
Have a documented diagnosis of HAE-1/HAE-2 (Type I or II)
Experience ≥1 Investigator-confirmed HAE attack in the first 4 weeks of Screening or ≥2 Investigator-confirmed HAE attacks in 8 weeks of Screening
Able to use at least one acute therapy to treat HAE attacks (such as a plasma-derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
Disqualifiers
Concurrent diagnosis of another form of recurrent angioedema (such as acquired angioedema, HAE with normal C1-INH (previously known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria).
Any clinically significant renal disease
Any clinically significant hepatic disease
C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
Trial design
Design model
Parallel
Treatments tested in this trial
ADX-324
DrugsiRNA duplex oligonucleotide
Placebo
Drugsaline
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: ADX-324 Dose Level 1Experimental treatment 1 intervention
Group B: ADX-324 Dose Level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of ADX-324 in preventing HAE attacks
The time-normalized number of Investigator-confirmed HAE attacks per month for ADX-324 Dose Level 1 vs placebo
Time frame
Day 22 to Week 25Secondary outcomes
1
Efficacy of ADX-324 in preventing HAE attacks
The time-normalized number of Investigator-confirmed HAE attacks per month for ADX-324 Dose Level 2 vs placebo
Time frame
Day 22 to Week 252
Evaluate the effects of ADX-324 on the quality and pattern of HAE attacks
The time-normalized number of Investigator-confirmed HAE attacks requiring acute HAE therapy per month for ADX-324 vs placebo.
Time frame
Day 22 to Week 253
Evaluate the effects of ADX-324 on the quality and pattern of HAE attacks
The time-normalized number of moderate or severe Investigator confirmed HAE attacks per month for ADX 324 vs placebo.
Time frame
Day 22 to Week 254
Evaluate the effects of ADX-324 on the quality and pattern of HAE attacks
The proportion of participants who have not experienced an Investigator-confirmed HAE attack (HAE attack-free) for ADX 324 vs placebo.
Time frame
Day 22 to Week 25Sponsors and contacts
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Source ClinicalTrials.gov