At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Deucrictibant (drug), Placebo (drug), Deucrictibant (drug), Placebo (drug)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- Deucrictibant — drug: Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use · Placebo — drug: Part 1: Placebo Comparator tablet for once daily oral use · Deucrictibant — drug: Part 2: Deucrictibant 20 mg soft capsule oral use · Placebo — drug: Part 2: Placebo Comparator soft capsule oral use · Deucrictibant — drug: Part 3: Deucrictibant 20 mg soft capsule oral use
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 48
- Started
- 2025-10-16
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acquired angioedema due to c1-inhibitor deficiency (aae-c1-inh)
- • Phase3 - 48 participants
- • 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 soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with acquired angioedema due to c1-inhibitor deficiency (aae-c1-inh)
Where?
- • Bristol - Study Site
- • Cambridge - Study Site
- • Leicester - Study Site
- • London - Study Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 soft capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
More detail
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 soft 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ to use contraception during the study
What the study is looking for
- ✓Provision of written agreement to take part
- ✓Male or female (sex at birth) aged ≥18 years
- ✓Diagnosis of AAE-C1INH
- ✓History of AAE-C1INH attacks prior to the Screening Visit.
- ✓If underlying disease associated with AAE is present, the underlying disease must be stable throughout the duration...
Who cannot take part
- ✗Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives...
- ✗Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
- ✗Abnormal liver function
- ✗Moderate or severe kidney impairment
- ✗Any clinically significant other health condition or systemic dysfunction that would interfere with the participant's safety or...
See the full criteria
Where Is This Study? (6 UK sites)
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
How to Get in Touch
Pharvaris Clinical Team
Sponsor contactCONTACT
