A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema.
This research is looking into a new oral medicine, a soft capsule called deucrictibant, for people who experience Hereditary Angioedema (HAE) attacks. The main goal is to find out how quickly this new medicine can ease symptoms compared to a dummy capsule (placebo) and an existing HAE treatment (icatibant). Participants will take the medicine when they have an attack, and researchers will carefully track how their symptoms improve over time. They want to see if people feel 'a little better' very quickly, and how long it takes for a more significant improvement or for symptoms to completely disappear. The study is for adults and aims to confirm if deucrictibant is an effective and fast-acting treatment for sudden HAE attacks.
At a glance
What is this study about?
This study is about finding a quicker way to help people who have sudden attacks from a condition called Hereditary Angioedema, or HAE. HAE causes unpredictable swelling attacks, which can be painful and sometimes dangerous. Researchers are testing a new medicine in a soft capsule called deucrictibant.
They want to see if this new medicine can stop an attack quickly and effectively. To do this, they’ll compare it to a dummy capsule (called a placebo, which looks like the real medicine but has no active ingredients) and another existing HAE medicine. This type of study is called a 'crossover study,' which means participants might try different treatments at different times during the study. This helps researchers get a clear picture of how each medicine works.
The main thing the study will measure is how fast people start to feel better after taking the medicine. They’ll look for clear signs of improvement, like feeling 'a little better' for two times in a row within 12 hours of taking the capsule. They will also track how long it takes for symptoms to greatly improve or completely go away, and if participants need other medicines to help with their attack.
Key takeaways
- Tests a new oral medicine (deucrictibant) for HAE attacks.
- Compares it to a dummy pill (placebo) and an existing treatment (icatibant).
- Aims to find out how quickly symptoms of HAE attacks improve.
- Designed for adults aged 18 and over.
- Participation helps future HAE treatments.
Who may be eligible?
To be part of this study, you must be an adult, as it is designed for people aged 18 and older. Both men and women can participate. The study is looking for individuals who have been diagnosed with Hereditary Angioedema (HAE) and experience attacks.
There might be other health or medication-related requirements that aren't listed here. These are put in place to ensure your safety and that the study results are clear and accurate. For example, if you have certain other medical conditions or are taking specific medications, you might not be able to join.
- Are you 18 years old or older?
- Have you been diagnosed with Hereditary Angioedema (HAE)?
- Do you experience HAE attacks?
- Are you able to take medicines by mouth (oral capsules)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be given one of the study medicines (deucrictibant, icatibant, or placebo) to take when you experience an HAE attack. You won't know which one you're taking, nor will the study doctors, until after the study is over. This is called 'double-blind'. You'll then keep track of your symptoms and how you feel, noting down when you start to feel better.
You'll be asked to attend clinic visits to check on your health and discuss your experiences. There will be careful monitoring of your condition and any side effects you might have. The study will involve trying different treatments over time, potentially switching between the active medicine and the dummy capsule. The total time you'd be involved in the study would be explained by the study team.
Potential risks and benefits
Locations (14)
- —Poland
- —Germany
- —Austria
- —Italy
- —Sweden
- —Bulgaria
- —Ireland
- —Hungary
- —Spain
- —Netherlands
- —Czechia
- —France
+2 more sites — see the official record for the full list.
Common questions
What is Hereditary Angioedema (HAE)?
HAE is a rare genetic condition that causes sudden and unpredictable attacks of swelling in different parts of the body, like the hands, feet, face, or airways.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers understand if the new medicine is truly effective.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the new medicine, the existing medicine, or the placebo during the study. This helps make the study fair and unbiased.
Will I have to pay to be in the study?
No, you will not have to pay for the study medication or any study-related tests or appointments.
What does a 'crossover study' mean?
A crossover study means you might try different treatments at different points over the study period. For example, you might take the new medicine for some attacks and the placebo for others.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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