Oral medication to prevent angioedema attacks in adolescents and adults with HAE

Is this trial a fit for you?

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

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of deucrictibant, an oral extended-release tablet, for preventing angioedema attacks in individuals aged 12 and older diagnosed with hereditary angioedema (HAE). Participants will be randomly assigned to receive either the active medication or a placebo for a 24-week treatment period, followed by a maximum 4-week follow-up. Throughout the study, participants will complete daily electronic diaries and questionnaires to monitor their health and treatment effects. The study aims to confirm the medication's effectiveness compared to placebo in reducing the frequency of angioedema attacks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of written informed consent/assent.
2. Male or female, aged ≥12 years at the time of providing written informed consent/assent.
3. Diagnosis of hereditary angioedema (HAE)
4. History of at least 3 HAE attacks within the 3 consecutive months prior to Screening Visit
5. Predefined number of attacks during the Screening Period
6. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
7. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
8. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.

Exclusion Criteria:

1. Any diagnosis of angioedema other than HAE
2. 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 Screening (whichever is longer)
3. Has received prior prophylactic treatment with deucrictibant
4. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
5. Prior gene therapy for any indication at any time
6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis
7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
8. Abnormal hepatic function
9. Moderate or severe renal impairment
10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization
13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug

Where it's running

• Study Site
  Little Rock, Arkansas, United States Recruiting
• Study site
  Santa Monica, California, United States Recruiting
• Study site
  Walnut Creek, California, United States Recruiting
• Study Site
  Wheaton, Maryland, United States Recruiting
• Study Site
  Saint Louis, Missouri, United States Recruiting
• Study Site
  Sofia, Bulgaria Recruiting

Study contacts

• Study coordinator: Pharvaris Clinical Team
• Email: clinicaltrials@pharvaris.com
• Phone: 0031-712-036-410

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Takhzyro use in teenagers and adults with hereditary angioedema in South Korea

  This study looks at how safe and useful Takhzyro is when used in real-world care for teenagers and adults with hereditary angioedema in South Korea.

  Recruiting at 3 sites Takeda · Suwon, Gyeonggi-do and 2 other locations · NCT07445087

• Long-term treatment with ADX-324 for people with hereditary angioedema

  This extension will try additional doses of ADX-324 (onvuzosiran) to see if continuing the drug is safe and helps people with Type I or II hereditary angioedema who finished the earlier Phase 3 trial.

  Recruiting at 3 sites Phase 3 ADARx Pharmaceuticals, Inc. · Litchfield Park, Arizona and 47 other locations · NCT07428499

• Donidalorsen for children with hereditary angioedema

  This trial tests if donidalorsen is safe and how it is processed in the body for children aged 2 to under 12 with hereditary angioedema types I or II.

  Recruiting at 18 sites Phase 3 Ionis Pharmaceuticals, Inc. · Santa Monica, California and 17 other locations · NCT07298447

• C1-Inhibitor Function Test to Diagnose HAE in Algeria

  A test that measures C1-inhibitor function is being tried to see if it can accurately diagnose hereditary angioedema in patients in Algeria.

  Recruiting Takeda · Algiers · NCT07293364

• Oral deucrictibant to prevent and treat hereditary angioedema attacks

  This trial tests whether daily oral deucrictibant XR can prevent angioedema attacks and whether deucrictibant capsules can quickly relieve acute attacks in adults with bradykinin-mediated hereditary angioedema.

  Recruiting Phase 1/2 Institute for Asthma and Allergy · Wheaton, Maryland · NCT07046806

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.