RecruitingPhase 3

STOP-HAE: A Phase 3 Study of ADX-324 in HAE

United States90 participantsStarted 2025-08-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. C1-INH agent (CINRYZE, HAEGARDA, RUCONEST) within 2 weeks prior to Screening.
✕. Berotralstat (ORLADEYO) within 3 weeks prior to Screening.
✕. Lanadelumab (TAKHZYRO) within 8 weeks prior to the Screening.
✕. Androgen use within 12 weeks prior to Screening.

What they're measuring

Efficacy of ADX-324 in preventing HAE attacks

Timeframe: Day 22 to Week 25

Trial details

NCT IDNCT06960213

SponsorADARx Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Lupe Gallegos

877-232-7974 lgallegos@adarx.com

View on ClinicalTrials.gov More Hereditary Angioedema trials