Wheaton, MDNCT07046806Now EnrollingIRB Ready

Hereditary Angioedema (HAE) Clinical Trial in Wheaton, MD

Access cutting-edge hereditary angioedema (hae) treatment through this clinical trial at a research site in Wheaton. Study-provided care at no cost to qualified participants.

Sponsored by Institute for Asthma and Allergy

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Expert Care in Wheaton

Access hereditary angioedema (hae) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hereditary angioedema (hae) treatment provided free

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Check if you qualify for this hereditary angioedema (hae) clinical trial in Wheaton, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Wheaton

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Wheaton site if eligible
  4. 4Begin participation

About This Hereditary Angioedema (HAE) Study in Wheaton

To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.

Sponsor: Institute for Asthma and Allergy

Who Can Participate

Inclusion Criteria

Provision of written informed consent.
Male or female, aged ≥18 at the time of provision of informed consent.
Diagnosis of bradykinin-mediated angioedema based upon all of the following:
Clinical history consistent with angioedema (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria), not responsive to treatments of anti-histamine, corticosteroid, and/or omalizumab.
Tried and failed at least 2 weeks of cetirizine 20 mg twice a day (or its equivalent alternative antihistamines, such as fexofenadine, loratadine, desloratadine or levocetirizine, etc.).
Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and/or attack period\*. \*The "attack period" is defined as within 24 hours after an attack.
Documented diagnostic testing results: C1INH antigen concentration and functional activity within normal range; C4 antigen concentration within normal range.
Documented history of at least 2 angioedema attacks in the previous 2 months.
Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.

Exclusion Criteria

Any diagnosis of angioedema other than BK-AE-nC1INH.
Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug at Screening (whichever was longer).
Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening.
Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in this study provided a sufficiently long washout period (≥5 half-life) is observed before the participant is screened. Exclusion includes use of: • Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.
Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
Abnormal hepatic function (aspartate aminotransferase \>2× upper limit of normal, alanine aminotransferase \>2× ULN, or total bilirubin \>1.5× upper limit of normal). Participants with Gilbert's syndrome, defined as isolated increase of total bilirubin ≤3× upper limit of normal and aspartate aminotransferase and alanine aminotransferase within the normal range, are not excluded.
Abnormal renal function (estimated glomerular filtration rate \[eGFR\] \<60 mL/min/1.73 m2).
Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant cardiovascular abnormality within the previous year that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study.
History of epilepsy and other significant neurological diseases.
Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption.
History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
Use of concomitant medications with systemic absorption that are moderate and strong inhibitors or strong inducers of CYP3A4, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, and grapefruit juice as well as carbamazepine, and rifampin 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 study drug.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Wheaton?

Yes, this clinical trial (NCT07046806) has an active research site in Wheaton, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hereditary Angioedema (HAE) Treatment Options in Wheaton, MD

If you're searching for hereditary angioedema (hae) treatment options in Wheaton, MD, this clinical trial (NCT07046806) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Wheaton research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hereditary angioedema (hae) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hereditary angioedema (hae) clinical trials near you to find additional studies recruiting in your area.

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