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

A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

Phase 3 Interventional Pharvaris Netherlands B.V. · NCT07266805

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
Enrollment32 (estimated)
Ages18 Years and up
SexAll
SponsorPharvaris Netherlands B.V. Industry-sponsored
Locations17 sites (Walnut Creek, California and 16 other locations)
Trial IDNCT07266805 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

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:
* Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH

  * The underlying condition can reasonably be expected to remain stable for the duration
* 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 (prepubertal, 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).
* Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the 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 inhibitors or any estrogen-containing medications

Where this trial is running

Walnut Creek, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acquired Angioedema Due to C1-Inhibitor DeficiencyAcquired Angioedema-C1-INHAAE-C1-INHOral TreatmentdeucrictibantProphylaxisOn-demandC1-Inhibitor Deficiency
Last reviewed 2026-06-13 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.