CompletedPhase 3

Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

United States134 participantsStarted 2024-02-26

Plain-language summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.

Who can participate

Age range12 Years – 75 Years

SexALL

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Inclusion criteria

✓. Provision of written informed consent/assent.
✓. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
✓. Diagnosis of HAE-1/2/3.
✓. History of at least 2 HAE attacks in the last 3 months before screening.
✓. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
✓. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
✓. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
✓. For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg.

Exclusion criteria

What they're measuring

Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.

Timeframe: Pre-treatment to 12 hours post-treatment.

Trial details

NCT IDNCT06343779

SponsorPharvaris Netherlands B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-17

View on ClinicalTrials.gov More Hereditary Angioedema trials