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New treatment option for Hereditary Angioedema (HAE)
Official title Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
ClinicalTrials.gov ID: NCT06679881
What this study is testing
What is Deucrictibant?
Deucrictibant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hereditary angioedema (hae).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema
- Phase 3: a large, late-stage study
- Time commitment: about 130 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Provision of the signed ICF by the participant and/or legally designated representative.
- Male or female, aged ≥12 years at the time of providing written informed consent/assent.
- Diagnosis of hereditary angioedema (HAE)
- For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive...
- Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
You likely can't join if
- Any diagnosis of angioedema other than HAE
- 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...
- Prior gene therapy for any indication at any time
- Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance...
- Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
- Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of...
See the full eligibility criteria
- Provision of the signed ICF by the participant and/or legally designated representative.
- Male or female, aged ≥12 years at the time of providing written informed consent/assent.
- Diagnosis of hereditary angioedema (HAE)
- For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening
- Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.
- Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.
- Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.
- Any diagnosis of angioedema other than HAE
- 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 ICF signature (whichever is longer)
- Prior gene therapy for any indication at any time
- Participants who discontinued from previous studies with deucrictibant prophylactic and/or on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with...
- Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening
- 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...
- 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 alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
- 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
- Known hypersensitivity to deucrictibant or any of the excipients of the study drug
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Walnut Creek, California, United States
- Wheaton, Maryland, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Hershey, Pennsylvania, United States
- Dallas, Texas, United States
- Milwaukee, Wisconsin, United States
- Corrientes, Argentina
- Pilar, Argentina
- Salta, Argentina
- Melbourne, Australia
- Perth, Australia
- Sydney, Australia
- Vienna, Austria
- Ribeirão Preto, Brazil
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 130 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; San Diego, California, United States; Santa Monica, California, United States; Walnut Creek, California, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.