Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
Start Date
10/16/2025
Completion Date
6/1/2027
Summary
This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Detailed Description
The study consists of a Screening Period, during which eligibility is confirmed, a Part 1 Prophylaxis Double-blind Treatment Phase, a Part 2 On-demand, Double-blind Treatment Phase, and a Part 3 On-demand Open-label Extension Phase. Approximately 24 participants will be randomized in Part 1 into 2 parallel arms for a treatment period of 12 weeks. During the prophylaxis treatment period participants will receive blinded study drug (deucrictibant 40 mg XR or placebo randomized in a 1:1 ratio). Upon completion of Part 1, participants will roll-over into Part 2. In addition to rollover participants completing Part 1, new deucrictibant treatment-naïve participants will be enrolled directly into Part 2 and this may occur while Part 1 is ongoing. During the on-demand period participants will receive blinded study drug (deucrictibant 20 mg IR capsule or matching placebo randomized in a 1:1 ratio, 2-period, 2-treatment crossover design) for 2 qualifying AAE-C1INH attacks. Participants completing Part 2 may roll over into Part 3 where all AAE-C1INH attacks will be treated with open-label deucrictibant 20 mg soft capsule.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Deucrictibant
Placebo
Deucrictibant
Placebo
Deucrictibant
Conditions
Locations
Study Site
San Diego, California 92093
United States
Study Site
Walnut Creek, California 94598,
United States
Study Site
St Louis, Missouri 63130
United States
Study Site
Hershey, Pennsylvania 17033
United States
Study Site
Clayton,
Australia
Study Site
Vienna,
Austria
Study Site
Sofia,
Bulgaria
Study Site
Edmonton,
Canada
Study Site
Grenoble,
France
Study Site
Lille,
France
Study Site
Paris,
France
Study Site
Berlin,
Germany
Study Site
Frankfurt am Main,
Germany
Study Site
Munich,
Germany
Study Site
Budapest,
Hungary
Study Site 1
Milan,
Italy
Study Site 2
Milan,
Italy
Study Site 3
Milan,
Italy
Study Site
Padova,
Italy
Study Site
Roma,
Italy
Study Site
Amsterdam,
Netherlands
Study Site
Auckland,
New Zealand
Study Site
Krakow,
Poland
Study Site
Madrid,
Spain
Study Site
Basel,
Switzerland
Study Site
Ankara,
Turkey (Türkiye)
Study Site
Bristol,
United Kingdom
Study Site
Cambridge,
United Kingdom
Study Site
Leicester,
United Kingdom
Study Site
London,
United Kingdom
Study Site
Newcastle upon Tyne,
United Kingdom
Study Site
Plymouth,
United Kingdom