CREAATE – A Study of Deucrictibant in People with Acquired Angioedema (AAE)

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

Who can take part?

You may be able to take part if you have acquired angioedema (AAE), a rare condition that causes episodes of swelling in different parts of the body, such as the face, hands, abdomen, or airways.

You may be eligible if you:

• Are 18 years of age or older
• Have a confirmed diagnosis of AAE due to C1 inhibitor deficiency
• Have a history of AAE attacks
• Have previously received treatment to prevent attacks (such as C1 inhibitor therapy or other medications)
• Have a stable underlying condition (if applicable)

You would not be able to take part if:

• You have an unstable or undiagnosed health condition
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether deucrictibant, an investigational oral medication, may help prevent and treat attacks of AAE.

• Study duration: Varies depending on study phase (up to several months or longer)
• Clinic visits: At least 6 onsite visits over approximately 24 weeks
• Phone calls: 2 study calls

The study includes:

• A screening period (up to 10 weeks)
• A prophylaxis treatment period (12 weeks)
• An on‑demand treatment phase (approximately 16 to 24 weeks)
• An open‑label extension phase (duration may vary)

What will I need to do?

If you take part, you will be asked to:

• Take the study medication as a daily oral tablet (during the prevention phase)
• Use the medication as needed to treat AAE attacks (during later phases)
• Attend clinic visits and study appointments
• Take part in assessments, which may include:
• • Blood and urine tests
  • A heart tracing (ECG)
  • Daily symptom questionnaires using an electronic device

The study doctor will monitor your symptoms and assess your eligibility to continue throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – Deucrictibant Study