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New treatment option for Acquired Angioedema Due to C1-Inhibitor Deficiency (AAE-C1-INH)
Official title 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
ClinicalTrials.gov ID: NCT07266805
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 acquired angioedema due to c1-inhibitor deficiency (aae-c1-inh).
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, 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment...
- 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...
See the full eligibility 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...
- Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.
- 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...
- Known hypersensitivity to deucrictibant or any of the excipients of the study drug
- Use of angiotensin-converting enzyme inhibitors or any estrogen-containing medications
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Walnut Creek, California, United States
- St Louis, Missouri, United States
- Hershey, Pennsylvania, United States
- Clayton, Australia
- Vienna, Austria
- Sofia, Bulgaria
- Edmonton, Canada
- Grenoble, France
- Lille, France
- Paris, France
- Berlin, Germany
- Frankfurt am Main, Germany
- Munich, Germany
- Budapest, Hungary
- Milan, Italy
- Padova, Italy
- Roma, Italy
- Amsterdam, Netherlands
- Auckland, New Zealand
+ 10 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 12 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Walnut Creek, California, United States; St Louis, Missouri, United States; Hershey, Pennsylvania, United States; Clayton, Australia; Vienna, Austria and 24 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.