Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

Study of Oral 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

Sponsor: Pharvaris Netherlands B.V.

NCT ID: NCT07266805

View on ClinicalTrials.gov ↗

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.

Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: * Provision of written informed consent * 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 of part 1. * Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks. * Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method. Females of non-childbearing potential (surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study. • Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training. Exclusion Criteria: * Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer). * Receiving long-term prophylaxis (LTP) treatment for AAE-C1INH and satisfied with this treatment. Participants who are not satisfied (eg, tolerability issues, lack of efficacy) and have previously stopped LTP treatment for AAE-C1INH, for reasons other than participation in this study, can sign the ICF and begin the Screening Period only if their last dose of the treatment was received prior to the timepoint before the Screening Visit * Any females who are pregnant, plan to become pregnant, or are currently breast-feeding * Abnormal hepatic function * Moderate or severe renal impairment * Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study. * History of epilepsy and/or other significant neurological diseases * Any clinically significant and uncontrolled gastrointestinal dysfunction that may impact study drug absorption * Evidence of current alcohol or drug abuse * Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit * Known hypersensitivity to deucrictibant or any of the excipients of the study drug * Use of angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 5 half-lives before the Screening Visit

Where Is This Study? (6 UK sites)

Study Site

Bristol, United Kingdom

Recruiting

Study Site

Cambridge, United Kingdom

Recruiting

Study Site

Leicester, United Kingdom

Recruiting

Study Site

London, United Kingdom

Recruiting

Study Site

Newcastle upon Tyne, United Kingdom

Recruiting

Study Site

Plymouth, United Kingdom

Recruiting

How to Get in Touch

Pharvaris Clinical Team

Sponsor contact

CONTACT

0031-712-036-410 clinicaltrials@pharvaris.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09