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Study of Deucrictibant Extended-Release Tablets for Prevention of Hereditary Angioedema Attacks in Adults and Adolescents

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Hereditary Angioedema, a rare genetic condition that causes unexpected episodes of severe swelling in various parts of the body. The research evaluates a new oral medication called deucrictibant, which is being tested as a preventive treatment to reduce the frequency of swelling attacks. The study will compare deucrictibant extended-release tablets to a placebo in adolescents and adults.

The study will test if taking a 40 mg tablet of deucrictibant daily can prevent or reduce the occurrence of swelling attacks compared to taking a placebo. For comparison purposes, some participants will also have access to icatibant, an already approved medication that is injected under the skin to treat acute attacks when they occur.

The treatment period will last 24 weeks, during which participants will take either deucrictibant or placebo tablets. Throughout the study, participants will need to keep track of any swelling attacks they experience and may use emergency treatment if needed. The study will monitor how well the medication works and check for any potential side effects through regular health assessments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    After qualifying for the study, you will enter an up to 8-week Run-in Period. During this time, your HAE attacks (sudden swelling episodes) will be monitored and confirmed by the investigator.

    You will need to record your symptoms in an electronic diary (eDiary) provided to you.

  2. Step 2

    Treatment period start

    The treatment period will last for 24 weeks (168 days).

    You will be randomly assigned to receive either deucrictibant 40 mg extended-release tablets or placebo tablets (tablets without active medication).

    The tablets should be taken by mouth (oral route).

  3. Step 3

    During treatment

    Throughout the 24-week period, you will need to record any swelling attacks in your electronic diary.

    You will have access to your regular on-demand medication (including icatibant given by injection under the skin) to treat any attacks that occur.

    You will complete several questionnaires about your quality of life and satisfaction with treatment.

    Regular health checks will include blood tests, vital signs measurements, and heart recordings (ECG).

  4. Step 4

    Monitoring

    The study team will track the number and severity of your swelling attacks.

    Any side effects or health changes will be recorded and monitored.

    Blood samples will be taken to measure the levels of the study medication in your body.

  5. Step 5

    Study completion

    The study will end after the 24-week treatment period.

    Final health assessments will be performed to evaluate the overall effects of the treatment.

Who can join the trial?

14 criteria

  • Must be at least 12 years old and provide written informed consent. For participants under 18, parental consent is required
  • Adolescents (12-18 years) must weigh at least 40 kg
  • Must have a confirmed diagnosis of Hereditary Angioedema (HAE) type 1/2 or type 3 with appropriate laboratory test results
  • Must have experienced at least 3 HAE attacks within 3 months before screening
  • Must have reliable access to standard treatments for managing acute HAE attacks
  • Must be willing and able to use electronic diary and patient reporting tools
  • Must be able to follow all study requirements
  • For women who can become pregnant:
    • Must agree to pregnancy testing
    • Must either remain abstinent or use highly effective contraception during the study and for 30 days after the last dose
    • For participants with HAE type 1/2:
      • Must have documented history of swelling without itching or hives
      • Must have either: symptoms starting before age 30, family history of HAE, or normal C1q levels
      • For participants with HAE type 3:
        • Must have confirmed normal C1-inhibitor function
        • Must have either genetic mutation associated with HAE type 3 or family history with confirmed elevated bradykinin levels
        • Must show response to icatibant treatment

Who cannot join the trial?

15 criteria

  • Age below 12 years old
  • Women who are pregnant or breastfeeding
  • History of severe allergic reactions to similar medications
  • Current use of other medications for hereditary angioedema prevention
  • Participation in other clinical trials within the past 30 days
  • Severe kidney or liver disease
  • Uncontrolled high blood pressure
  • Major surgery planned during the study period
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with following study procedures
  • Any condition that, in the investigator's opinion, makes participation unsafe
  • Inability or unwillingness to follow study procedures
  • History of blood clotting disorders
  • Active cancer or cancer treatment
  • Serious heart conditions or recent heart problems
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Investigated drugs

Deucrictibant is a medication being studied as a preventive treatment for hereditary angioedema (HAE), a rare condition that causes sudden swelling attacks in different parts of the body. This medication comes in an extended-release tablet form that is taken by mouth. It works by helping to prevent the swelling attacks that are typical in people with hereditary angioedema. The medication is designed to be taken regularly as a preventive measure, rather than treating attacks after they occur.

What is already known about the treatment

Deucrictibant - An oral medication administered in extended-release tablet form (40 mg) that is currently being investigated in Phase 3 clinical trials for the prevention of angioedema attacks in patients with Hereditary Angioedema (HAE). The drug belongs to the class of targeted therapeutics designed to prevent swelling episodes in HAE patients by acting as a plasma kallikrein inhibitor at the molecular level. This investigational treatment represents a potential advancement in HAE management by offering a convenient oral administration method for prophylactic therapy, as compared to some existing injectable treatments.

Investigated diseases

Hereditary Angioedema - A genetic condition that causes recurring episodes of severe swelling in various parts of the body. The swelling typically affects the hands, feet, face, airway, and intestinal walls. Episodes can occur spontaneously or be triggered by stress, minor injuries, or other factors. The condition is caused by a deficiency or dysfunction of certain blood proteins that help regulate swelling. Between episodes, patients may have no visible symptoms. The swelling episodes typically develop slowly over 24 hours and can last for several days.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516247-62-00Protocol codePHA022121-C305Estimated enrolment75 patientsSponsorPharvaris Netherlands B.V.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).