CREAATE

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant XR Tablet for Prophylaxis and Deucrictibant Soft Capsule for On-demand Treatment of Angioedema Attacks in Adults with Acquired Angioedema due to C1 Inhibitor Deficiency

• IRAS ID

  1012598

• Contact name

  Aleese Hopkins

• Contact email

  aleese.hopkins@pharvaris.com

• Sponsor organisation

  Pharvaris Netherlands BV

• Research summary

  This study is testing a drug (called deucrictibant) to see how safe and effective it is for people who have sudden swelling attacks (acquired angioedema) because of low levels of a protective protein in their blood (called C1 Inhibitor). This condition is known as acquired angioedema (AAE) C1INH. During certain parts of the study, some people in the study may receive a placebo instead of the real drug being tested. A placebo looks like the real drug but has no active drug in it.
  About 32 adults (age 18 years and up) will be part of this study after going through a screening period. People who have used other preventative treatments must have discontinued those treatments for a sufficient time period.
  The study is divided into 3 main parts:
  1. Prevention Phase: Participants take the drug or placebo regularly to see if it can help stop the attacks before they happen.
  2. On-demand Treatment Phase: Participants take a soft capsule version of the drug or placebo during an attack to see if it helps stop it.
  3. Long-Term Use Phase: Participants continue to take the drug during an attack to check for long-term safety and how well it is tolerated.

  This study is testing a drug (called deucrictibant) to see how safe and effective it is for people who have sudden swelling attacks (acquired angioedema) because of low levels of a protective protein in their blood (called C1 Inhibitor). This condition is known as acquired angioedema (AAE) C1INH. During certain parts of the study, some people in the study may receive a placebo instead of the real drug being tested. A placebo looks like the real drug but has no active drug in it. This helps researchers compare results fairly.
  About 32 adults (age 18 years and up) will be part of this study after going through a screening period. People who have used other preventative treatments must have discontinued those treatments for a sufficient time period.
  The study is divided into 3 main p

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  25/LO/0623

• Date of REC Opinion

  29 Sep 2025

• REC opinion

  Further Information Favourable Opinion