Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)
Recruiting
Phase 3
Interventional Study
Hereditary Angioedema (HAE)
Hereditary Angioedema - Type 1
Hereditary Angioedema - Type 2
HAE
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- ADARx Pharmaceuticals, Inc. · Industry
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About This Trial
Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurem…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Have a documented diagnosis of HAE (Type I or II)
* Completed Study ADX-324-301
* Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)
Exclusion Criteria:
* A negative reaction to study d…
Contacts