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Study on Deucrictibant and Icatibant for Treating Hereditary Angioedema Attacks in Adolescents and Adults

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What is this trial about?

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

This clinical trial is focused on studying a condition known as Hereditary Angioedema, which is a rare genetic disorder that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The study is testing a new treatment called Deucrictibant (PHA-022121), which is taken as a soft capsule by mouth. The purpose of the study is to see how effective Deucrictibant is in providing relief from the symptoms of Hereditary Angioedema attacks compared to a placebo.

Participants in the study will be randomly assigned to receive either the Deucrictibant capsule or a placebo during different periods of the study. This is known as a crossover study, meaning that each participant will have the chance to receive both the actual medication and the placebo at different times. The study will last for a period of up to 42 days, during which participants will take the medication as needed when they experience an attack. The researchers will monitor how quickly and effectively the medication provides relief from symptoms.

The study aims to gather information on how well Deucrictibant works in reducing the time it takes for symptoms to improve during an attack. This information will help determine if Deucrictibant can be a reliable on-demand treatment option for people with Hereditary Angioedema. Participants will be asked to record their symptoms and any changes they experience using an electronic diary, which will help the researchers assess the effectiveness of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will provide written consent. If the participant is a minor, consent will be obtained from a parent or legal guardian, and the participant will provide written assent.

  2. Step 2

    Initial assessment

    The participant will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of hereditary angioedema (HAE) and a history of at least two HAE attacks in the last three months.

  3. Step 3

    Medication administration

    The participant will receive deucrictibant in the form of a soft capsule, taken orally. This medication is used for on-demand treatment during HAE attacks.

    A placebo, which looks like the deucrictibant capsule but does not contain the active substance, may also be administered as part of the study's design.

  4. Step 4

    Monitoring and recording

    The participant will record their symptoms and any changes using an electronic diary. This includes noting the time to onset of symptom relief and any other relevant observations.

  5. Step 5

    Evaluation of symptom relief

    The primary goal is to evaluate the time to onset of symptom relief, defined as a noticeable improvement in symptoms within 12 hours after taking the medication.

    Secondary evaluations include the proportion of attacks achieving symptom relief at various time points and the need for any additional medication.

  6. Step 6

    Completion of study participation

    The study is expected to conclude by September 30, 2025. Participants will continue to be monitored and provide data until the end of their involvement in the study.

Who can join the trial?

12 criteria

  • The participant, or their parent/caregiver if they are an adolescent, must be willing and able to follow the study rules according to the Investigator's opinion.
  • Female participants who can have children must agree to pregnancy testing and either not engage in heterosexual intercourse or use a reliable birth control method during the study and for 30 days after the last dose of the study drug. Male participants do not have these requirements.
  • Participants must be male or female, aged between 12 and 75 years at the time they agree to join the study.
  • Participants must have a diagnosis of **Hereditary Angioedema (HAE)** type 1 or 2, which includes:
    • A history of swelling under the skin or in mucous membranes without itching, and no hives.
    • At least one of the following: symptoms started before age 30, a family history of HAE, or a specific blood test result.
    • Blood test results confirming HAE type 1 or 2, with specific conditions for those on certain long-term treatments.
    • Participants must have had at least 2 HAE attacks in the 3 months before joining the study.
    • Participants must have experience using standard treatments to manage HAE attacks when they occur.
    • If participants are on long-term preventive treatment for HAE with certain medications, they must have been on a stable dose for at least 6 months before joining the study and plan to continue the same dose during the study.
    • Participants must be able to use an electronic device to record their HAE symptoms and other information without help, as shown during the screening phase.
    • Adolescent participants aged 12 to less than 18 years must weigh at least 40 kg (about 88 pounds).
    • Participants must provide written consent to join the study. If the participant is under 18, their parent or legal guardian must give consent, and the participant must also agree in writing, following local laws.

Who cannot join the trial?

10 criteria

  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other significant medical condition that might interfere with the study.
  • Patients who have used certain medications that could affect the study results.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients with a known infection that could affect the study.
  • Patients who have a mental health condition that might interfere with their ability to participate.
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Investigated drugs

Deucrictibant is an oral medication being studied for its ability to provide relief during attacks of hereditary angioedema (HAE). This condition causes sudden swelling in various parts of the body, and the medication is designed to be taken as needed when an attack occurs. The goal of the trial is to determine how effectively deucrictibant can reduce symptoms and provide relief compared to not taking any active medication.

What is already known about the treatment

Deucrictibant – Deucrictibant is administered orally in the form of a soft capsule and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating hereditary angioedema (HAE) attacks. This medication is designed to provide on-demand relief from symptoms during HAE episodes. It works by targeting specific pathways involved in the inflammatory response that leads to swelling in HAE. Deucrictibant is classified as a treatment for hereditary angioedema, focusing on reducing the severity and duration of attacks.

Investigated diseases

Hereditary Angioedema – Hereditary Angioedema is a genetic disorder characterized by recurrent episodes of severe swelling, often affecting the face, extremities, gastrointestinal tract, and airway. These episodes, known as attacks, can occur spontaneously or be triggered by stress, trauma, or certain medications. The swelling is due to a deficiency or dysfunction of a protein called C1 inhibitor, which leads to an overproduction of bradykinin, a peptide that increases vascular permeability. Attacks can vary in frequency and severity, with some individuals experiencing them more frequently than others. The condition is typically inherited in an autosomal dominant pattern, meaning a single copy of the altered gene in each cell is sufficient to cause the disorder. Swelling episodes can be painful and debilitating, but they do not cause permanent damage to tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507268-37-00Protocol codePHA022121-C306Estimated enrolment120 patientsSponsorPharvaris Netherlands B.V.

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