NCT07266805 Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency
| NCT ID | NCT07266805 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pharvaris Netherlands B.V. |
| Condition | Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 32 participants in total. It began in 2025-10-16 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.
Eligibility 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
Contact & Investigator
Study Director, Pharvaris
STUDY DIRECTOR
Pharvaris Netherlands B.V.
Frequently Asked Questions
Who can join the NCT07266805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07266805 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 32 participants.
Is NCT07266805 currently recruiting?
Yes, NCT07266805 is actively recruiting participants. Contact the research team at clinicaltrials@pharvaris.com for enrollment information.
Where is the NCT07266805 trial being conducted?
This trial is being conducted at San Diego, United States, Walnut Creek, United States, St Louis, United States, Hershey, United States and 11 additional locations.
Who is sponsoring the NCT07266805 clinical trial?
NCT07266805 is sponsored by Pharvaris Netherlands B.V.. The principal investigator is Study Director, Pharvaris at Pharvaris Netherlands B.V.. The trial plans to enroll 32 participants.