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Oral treatment for on-demand relief of hereditary angioedema attacks

A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema

Phase 3 Interventional Pharvaris Netherlands B.V. · NCT06343779

This study is testing an oral medication called deucrictibant to see if it can help relieve attacks in people aged 12 to 75 with hereditary angioedema.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages12 Years to 75 Years
SexAll
SponsorPharvaris Netherlands B.V. Industry-sponsored
Drugs / interventionslanadelumab
Locations76 sites (Birmingham, Alabama and 75 other locations)
Trial IDNCT06343779 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of deucrictibant, an oral medication, for treating hereditary angioedema (HAE) attacks in adolescents and adults. Participants aged 12 to 75 with HAE type 1, type 2, or type 3 will be randomized to receive either deucrictibant or a placebo during two treatment periods. The study includes a screening phase to confirm eligibility and an end-of-study follow-up after treatment. Additionally, pharmacokinetic samples will be collected from adolescent participants to assess the drug's behavior in the body.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 to 75 with a diagnosis of hereditary angioedema and a history of recent attacks.

Not a fit: Patients who do not have hereditary angioedema or those who have not experienced recent attacks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide effective on-demand relief for patients experiencing hereditary angioedema attacks.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated in a Phase 3 setting, indicating a significant step towards potential approval.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Provision of written informed consent/assent.
2. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
3. Diagnosis of HAE-1/2/3.
4. History of at least 2 HAE attacks in the last 3 months before screening.
5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
8. For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg.
9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.

Exclusion Criteria:

1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.
2. Any diagnosis of angioedema other than HAE.
3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
5. Abnormal hepatic function.
6. Abnormal renal function (eGFR \<60 ml/min/1.73 m2).
7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
8. Has received prior on-demand HAE treatment with deucrictibant.
9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
10. Prior gene therapy for any indication at any time.
11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
12. Known hypersensitivity to study drug or any of the excipients of study drug.

Where this trial is running

Birmingham, Alabama and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

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 Hereditary AngioedemaHereditary Angioedema Type IHereditary Angioedema Type IIHereditary Angioedema Types I and IIHereditary Angioedema AttackHereditary Angioedema With C1 Esterase Inhibitor DeficiencyHereditary Angioedema - Type 1Hereditary Angioedema - Type 2
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.