CompletedPhase 2

Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

United States74 participantsStarted 2021-02-03

Plain-language summary

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Signed and dated informed consent form
✓. Diagnosis of HAE type I or II
✓. Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
✓. Reliable access and experience to use standard of care acute attack medications

Exclusion criteria

✕. Pregnancy or breast-feeding
✕. Clinically significant abnormal electrocardiogram
✕. Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
✕. Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
✕. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
✕. Abnormal hepatic function
✕. Abnormal renal function
✕. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse

What they're measuring

Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment

Timeframe: Assessed from pre-treatment to 4 hours post-treatment

Trial details

NCT IDNCT04618211

SponsorPharvaris Netherlands B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-23

Results submitted2025-06-13

View on ClinicalTrials.gov More Hereditary Angioedema trials