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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Pharvaris Netherlands B.V. Industry-sponsored |
| Locations | 32 sites (San Diego, California and 31 other locations) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07266805 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
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San Diego, California, United States Recruiting -
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Walnut Creek, California, United States Recruiting -
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St Louis, Missouri, United States Recruiting -
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Hershey, Pennsylvania, United States Recruiting -
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Clayton, Australia Recruiting -
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Vienna, Austria Recruiting
Show 26 more locations
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Sofia, Bulgaria Recruiting -
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Edmonton, Canada Recruiting -
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Grenoble, France Recruiting -
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Lille, France Recruiting -
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Paris, France Recruiting -
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Berlin, Germany Recruiting -
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Frankfurt am Main, Germany Recruiting -
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Munich, Germany Recruiting -
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Budapest, Hungary Recruiting -
Study Site 1
Milan, Italy Recruiting -
Study Site 2
Milan, Italy Recruiting -
Study Site 3
Milan, Italy Recruiting -
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Padova, Italy Recruiting -
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Roma, Italy Recruiting -
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Amsterdam, Netherlands Recruiting -
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Auckland, New Zealand Recruiting -
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Krakow, Poland Recruiting -
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Madrid, Spain Recruiting -
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Basel, Switzerland Recruiting -
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Ankara, Turkey (Türkiye) Recruiting -
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Bristol, United Kingdom Recruiting -
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Cambridge, United Kingdom Recruiting -
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Leicester, United Kingdom Recruiting -
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London, United Kingdom Recruiting -
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Newcastle upon Tyne, United Kingdom Recruiting -
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Plymouth, United Kingdom Recruiting
Study contacts
- Study coordinator: Pharvaris Clinical Team
- Email: clinicaltrials@pharvaris.com
- Phone: 0031-712-036-410
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.