CREAATE – Acquired Angioedema due to C1 Inhibitor Deficiency

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

Study Population

This is a 3-part study looking at orally administered deucrictibant in approximately 32 participants across 14 countries globally, for the prevention and treatment of Acquired Angioedema due to C1 Inhibitor Deficiency (AAE-C1INH) attacks.

Acquired Angioedema (AAE), occurs when a protein in the blood called C1 inhibitor doesn't work properly or is present in very low amounts. This leads to a chemical imbalance in the body, causing too much of a substance called bradykinin to be produced. Too much bradykinin produces the symptoms of AAE attacks: episodes of swelling and pain in different parts of the body, such as the face, hands, abdomen, or airways. These symptoms can come on suddenly and may be severe. 

Eligible participants:

• ≥18 years of age
• have a diagnosis of AAE-C1INH (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria) with C1INH functional level <40%, as demonstrated by chromogenic assay
• History of AAE-C1INH attacks
• have previously received long-term prophylaxis (LTP) treatment, such as C1INH, oral or parenteral kallikrein inhibitors, androgens, or antifibrinolytics
• Stable underlying disease of AAE-C1INH, if diagnosed, defined as: a). Lymphoproliferative disease b). Immune complex disorders or monoclonal gammopathy of undetermined significance OR c). other diseases (eg, Systemic Lupus Erythematosus)
• Maintenance treatment should be stable for at least 6 months prior screening visit

Participants with an undiagnosed or unstable disease,will not be eligible to participate in the study until stable.

Pregnant or lactating women are ineligible for participation.

Study Visits        

The study comprises of a Screening period of up to 10 weeks, 12-weeks Prophylaxis Treatment (Part 1)*, an On-demand Treatment Phase (Part 2) is approximately 16 to 24 weeks and an Open-Label On-demand Treatment Phase (Part 3), available until the last person in the study finishes.

*At a minimum you will be required to attend 6 onsite visits over approximately 24 weeks, with 2 phone contacts.

The study doctor will assess AAE attacks and eligibility to continue the study.

Study Requirements

• Part 1 Self-administer oral daily dose of Deucrictibant; Part 2 and Part 3 on-demand treatment of Deucrictibant
• Blood and urine tests, ECG at selected onsite visits
• Completion of daily questionnaires on an electronic device
  

Clinical Trials Link

tba 25Nov2025.