90 Participants NeededMy employer runs this trial

ADX-324 for Hereditary Angioedema

Recruiting at 47 trial locations
LG
Overseen ByLupe Gallegos
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: ADARx Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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) measurements.

Who Is on the Research Team?

LF

Lauge Farnaes, MD

Principal Investigator

ADARx Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with HAE Type I or II.
* Completed Study ADX-324-301
I have medicine available to treat sudden HAE attacks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Extension Treatment

Participants receive additional dosing of ADX-324 to assess safety and efficacy

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ADX-324

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ADX-324 Dose Level 2Experimental Treatment1 Intervention
Group II: ADX-324 Dose Level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ADARx Pharmaceuticals, Inc.

Lead Sponsor

Trials
3
Recruited
220+