Clinical trial Recruiting at 32 sites Phase 3 Interventional Ages 18 and up

Oral deucrictibant to prevent and to stop acquired C1‑inhibitor angioedema attacks in adults

Official title: 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

Run by Pharvaris Netherlands B.V. · NCT07266805 · Data updated 2026-11-12

This trial will test whether a once-daily extended‑release tablet can prevent angioedema attacks and whether an immediate‑release capsule can stop attacks when they occur in adults with acquired C1‑inhibitor deficiency.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment48 (estimated)
SponsorPharvaris Netherlands B.V.
Industry-sponsored
Locations32 sites (San Diego, California and 31 other locations)
StatusRecruiting
StartedOctober 16, 2025
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedSeptember 21, 2026
Trial IDNCT07266805 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with a confirmed diagnosis of acquired C1‑inhibitor deficiency, a history of attacks, and stable underlying disease (for the prophylaxis part) who can use an electronic diary and adhere to study visits are the ideal candidates.

Probably not a fit

People without AAE‑C1‑INH, with unstable underlying disease, who cannot take oral medication or cannot comply with study procedures are unlikely to benefit from participating.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multicenter, three-part study with two randomized, double‑blind, placebo‑controlled parts and an open‑label extension to test oral deucrictibant for both prevention and on‑demand treatment of AAE‑C1‑INH. Part 1 randomizes about 24 participants 1:1 to deucrictibant 40 mg XR or placebo for 12 weeks of prophylaxis, after which participants may roll over into the on‑demand parts. Part 2 uses a 2‑period, 2‑treatment crossover design to randomize deucrictibant 20 mg IR versus placebo for two qualifying attacks, and Part 3 is an open‑label extension where attacks are treated with deucrictibant 20 mg. Key outcomes include attack frequency, effectiveness of on‑demand dosing for treating attacks, and safety and tolerability.

Why it matters

Potential benefit: If successful, deucrictibant could reduce the number of angioedema attacks and offer an easy-to-take oral option to treat attacks when they happen.

How similar studies have gone: Injectable bradykinin B2 receptor antagonists like icatibant have proven effective for bradykinin‑mediated angioedema, and oral deucrictibant is a newer, promising approach with encouraging early‑phase data but limited large‑scale results so far.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Study Site
    San Diego, California, United States
    Recruiting
  • Study Site
    Walnut Creek, California, United States
    Recruiting
  • Study Site
    St Louis, Missouri, United States
    Recruiting
  • Study Site
    Hershey, Pennsylvania, United States
    Recruiting
  • Study Site
    Clayton, Australia
    Recruiting
  • Study Site
    Vienna, Austria
    Recruiting
Show 26 more locations
  • Study Site
    Sofia, Bulgaria
    Recruiting
  • Study Site
    Edmonton, Canada
    Recruiting
  • Study Site
    Grenoble, France
    Recruiting
  • Study Site
    Lille, France
    Recruiting
  • Study Site
    Paris, France
    Recruiting
  • Study Site
    Berlin, Germany
    Recruiting
  • Study Site
    Frankfurt am Main, Germany
    Recruiting
  • Study Site
    Munich, Germany
    Recruiting
  • Study Site
    Budapest, Hungary
    Recruiting
  • Study Site 1
    Milan, Italy
    Recruiting
  • Study Site 2
    Milan, Italy
    Recruiting
  • Study Site 3
    Milan, Italy
    Recruiting
  • Study Site
    Padova, Italy
    Recruiting
  • Study Site
    Roma, Italy
    Recruiting
  • Study Site
    Amsterdam, Netherlands
    Recruiting
  • Study Site
    Auckland, New Zealand
    Recruiting
  • Study Site
    Krakow, Poland
    Recruiting
  • Study Site
    Madrid, Spain
    Recruiting
  • Study Site
    Basel, Switzerland
    Recruiting
  • Study Site
    Ankara, Turkey (Türkiye)
    Recruiting
  • 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

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.