Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharvaris Netherlands B.V.

About this trial

This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

Eligibility criteria

Qualifiers

Provision of written informed consent

Male or female (sex at birth) aged ≥18 years

Diagnosis of AAE-C1INH

Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH

Disqualifiers

Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).

Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit

Any females who are pregnant, plan to become pregnant, or are currently breast-feeding

Abnormal hepatic function

Trial design

Treatments tested in this trial

  • Deucrictibant
  • Placebo
  • Deucrictibant
  • Placebo
  • Deucrictibant

Treatment groups

32 Participants
are divided into 5 treatment groups

Sponsors and collaborators