Hereditary Angioedema (HAE)Phase 1/2BK-AE-nC1INHNCT07046806
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
A Phase 1/2 study testing Deucrictibant XR tablet and Deucrictibant 20 mg capsule in people with Hereditary Angioedema (HAE) and Angioedema, run by Institute for Asthma and Allergy at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hereditary Angioedema (HAE), Angioedema, Bradykinin-mediated Angioedema
- What is being tested?
- Deucrictibant XR tablet and Deucrictibant 20 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute For Asthma & Allergy
Wheaton, Maryland, 20902
Henry LI, MD, PhD, 301-962-5800, info@allergyasthma.gov
About this study
Official title: Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)
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.
Read the detailed description
Study Design:
The study has 2-parts, studying the efficacy of deucrictibant versus placebo for prophylactic and on-demand treatment of angioedema attacks will be assessed in adult participants with BK-AE-nC1INH. Each part of the study is designed a randomized, double-blind, placebo-controlled cross-over trial. Up to 10 patients to be enrolled.
Deucrictibant has been adopted as the international nonproprietary name (INN) for the active ingredient, previously referred to as PHA121 or PHA-022121. Deucrictibant is under development as an orally administered bradykinin B2 receptor antagonist with potential for both acute therapeutic and prophylactic use in patients with different types of BK-mediated angioedema, including HAE-1/2, HAE with normal C1INH, acquired angioedema due to C1INH deficiency, and non-hereditary BK-mediated angioedema with normal C1INH.
Throughout the study (Parts 1 and 2), a diary will be used to record all symptoms and details of angioedema attacks, including on-demand treatments, as well as Patient Reported Outcomes (PROs). Participants need to have access to FDA approved on-demand angioedema medication and be able to treat any angioedema attack that may occur using standard of care on-demand therapies. In addition to the collected data on angioedema attacks, the diary will be used as a dosing diary for the daily intake of study drug treatment in Part 1.
Part 1 will evaluate the efficacy and safety of deucrictibant administered orally for prophylaxis against angioedema attacks in patients with BK-AE-nC1INH. After providing written informed consent, participants will be screened for eligibility. Eligible participants will be enrolled in the study. Participants receiving angioedema medications for long-term prophylaxis (LTP) will discontinue and washout these medications prior to Screening.
Dosing schedule: QD administration of study drug or placebo (double blind) throughout the Treatment Period consisting of deucrictibant (40 mg strength) XR tablet and matching placebo for oral use.
The duration of an individual's participation in Part 1 is up to 24 weeks (12 weeks on each deucrictibant and placebo, in random order).
Participants will be randomized in a 1:1 ratio to receive deucrictibant 40 mg XR tablet or matching placebo once daily (QD) each for 12 weeks and then participants will be crossed over, for a total of 24 weeks of treatment.
Part 2: After completion of Part 1, a study visit will be conducted at Week 24, at which the enrolled participants will be re-randomized in Part 2 on a 1:1 ratio to a treatment sequence to receive deucrictibant 20 mg soft capsule following by matching placebo or vice versa, with one capsule given for each of 2 attacks. Participants will self-administer blinded study drug in the assigned treatment sequence at home to treat 2 non-laryngeal qualifying angioedema attacks (at least one attack symptom [skin pain, skin swelling, or abdominal pain] has reached the individual item score of ≥20 in VAS-3). The time of administration of study drug as well as rescue medication must be recorded in the patient diary.The expected duration of Part 2 is up to 16 weeks.
End-of-Treatment and End-of-Study visits will occur within 7±2 days and 28 days (-14 days), respectively, after treatment of the second attack in Part 2.
Dosing schedule: Administration of study drug for acute angioedema attacks, dosing consists of deucrictibant (20 mg strength) soft capsule and matching placebo for oral use.
The duration of treatment in Part 2 is approximately 16 weeks.
Efficacy will be assessed based upon the occurrences of angioedema attacks, which will be confirmed by Investigators. During Screening, site personnel will discuss with participants the requirements for reporting angioedema attacks, including the information that is to be captured for each angioedema attack.
A Statistical Analysis Plan (SAP) will be finalized prior to database lock and will include a more technical and detailed description of all planned statistical analyses of all study endpoints.
The analysis of safety and tolerability will be performed on the Safety Analysis Set (ie, all randomized participants who have received at least 1 dose of study drug). Treatment-emergent AEs (TEAEs) are defined as AEs that start or pre-existing AEs that have worsened after the initiation of study drug.
The number and percentage of participants with TEAEs will be summarized by treatment group by body system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA®). Clinical laboratory data, vital signs, physical examination, and ECG data will be presented in summary tables and individual listings by treatment group.
- Conditions
- Hereditary Angioedema (HAE), Angioedema, Bradykinin-mediated Angioedema, C1 Inhibitor Deficiency
- Being tested
- Deucrictibant XR tablet, Placebo comparator to XR tablet, Deucrictibant 20 mg capsule, Placebo comparator to 20 mg capsule
- Keywords
- Bradykinin, deucrictibant, HAE, BK-AE-nC1INH, nC1INH, C1 Inhibitor, C4
- Medical subject headings
- Angioedemas, Hereditary, Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deucrictibant XR tabletDrug
Also called Deucrictibant XR
Deucrictibant 40 mg XR tablet for prophylaxis
Placebo comparator to XR tabletDrug
Also called Placebo
Placebo comparator to deucrictibant 40 mg XR tablet, prophylaxis
Deucrictibant 20 mg capsuleDrug
Also called Deucrictibant
Deucrictibant active drug for on-demand treatment of angioedma attacks
Placebo comparator to 20 mg capsuleDrug
Also called Placebo
Placebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks
| Study group | Role | What they receive |
|---|---|---|
| Deucrictibant XR tablet, 40 mg, prophylaxis | Experimental | Deucrictibant XR tablet, 40 mg, QD, oral use for 12 weeks Receives: Drug: Deucrictibant XR tablet |
| Placebo to deucrictibant XR tablet, 40 mg, prophylaxis | Placebo comparator | Placebo tablets, 40 mg equivalent, QD, oral use for 12 weeks Receives: Drug: Placebo comparator to XR tablet |
| On-demand deucrictibant 20 capsule, oral use | Experimental | Single 20 capsule orally for treatment of on-demand angioedema attack, for up to 16 weeks Receives: Drug: Deucrictibant 20 mg capsule |
| Placebo comparator to on-demand deucrictibant 20 capsule, oral use | Placebo comparator | Placebo capsules for treatment of on-demand angioedema attacks, for up to 16 weeks Receives: Drug: Placebo comparator to 20 mg capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part-1: Incidence and quality of HAE attacks comparing active versus placebo arms.
Part-1: Time-normalized number of Investigator-confirmed moderate or severe angioedema attacks during the Treatment Period. Time-normalized number of Investigator-confirmed angioedema attacks treated with on-demand medication during the Treatment Period.
Measured: 24 weeks
Part-2: Efficacy of active on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks
Part-2: Time to onset of symptom relief of active drug versus placebo, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
Measured: 16 weeks
Secondary outcomes (2)
Safety assessment of oral deucrictibant extended release (XR) tablet (Part 1), and deucrictibant oral on-demand tablets (Part 2).
Adverse event severity, expectedness, and relatedness of the active drug, classified based on their severity, whether they were expected, and their potential relationship to the study intervention (Parts 1 and 2).
Measured: 40 weeks
Part-1: Change in Health-Related Quality of Life (HRQoL) Scores Between Active Drug and Placebo Periods
Assessment of quality of life will be conducted using a validated disease-specific instrument, such as the Hereditary Angioedema Quality of Life Questionnaire (HAE-QoL), and supplemented by a daily patient diary Daily diary entries will record the presence or absence of attacks, their severity, duration, body location, treatment used, time to resolution, and the impact on daily living (missed work/school, physical limitations, mood, and social activities).documenting physical, emotional, and functional impacts of each attack.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Mar 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Asthma and Allergy
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046806
- Sponsor's protocol ID
- IAA-PHA-ISR01a
- Acronym
- BK-AE-nC1INH
- Status last verified
- Jun 2025
- First submitted
- 9 May 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial Individual Participant Data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA) at least 9 months after the publication date.
Publications
Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, Metz M, Staubach P, Maurer M. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012 Oct;67(10):1289-98. doi: 10.1111/all.12007. Epub 2012 Aug 23.
PubMed 22913638Riedl MA, Danese M, Danese S, Ulloa J, Maetzel A, Audhya PK. Hereditary Angioedema With Normal C1 Inhibitor: US Survey of Prevalence and Provider Practice Patterns. J Allergy Clin Immunol Pract. 2023 Aug;11(8):2450-2456.e6. doi: 10.1016/j.jaip.2023.01.023. Epub 2023 Jan 30.
PubMed 36720386Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
PubMed 22123383
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)
- ClinicalTrials.gov ID
- NCT07046806
- Acronym / sponsor ID
- BK-AE-nC1INH / IAA-PHA-ISR01a
- Conditions
- Hereditary Angioedema (HAE), Angioedema, Bradykinin-mediated Angioedema, C1 Inhibitor Deficiency
- Keywords
- Bradykinin, deucrictibant, HAE, BK-AE-nC1INH, nC1INH, C1 Inhibitor, C4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute for Asthma and AllergyResearch network
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
The study has 2-parts, studying the efficacy of deucrictibant versus placebo for prophylactic and on-demand treatment of angioedema attacks will be assessed in adult participants with BK-AE-nC1INH. Each part of the study is designed a randomized, double-blind, placebo-controlled cross-over trial. Up to 10 patients to be enrolled.
Deucrictibant has been adopted as the international nonproprietary name (INN) for the active ingredient, previously referred to as PHA121 or PHA-022121. Deucrictibant is under development as an orally administered bradykinin B2 receptor antagonist with potential for both acute therapeutic and prophylactic use in patients with different types of BK-mediated angioedema, including HAE-1/2, HAE with normal C1INH, acquired angioedema due to C1INH deficiency, and non-hereditary BK-mediated angioedema with normal C1INH.
Throughout the study (Parts 1 and 2), a diary will be used to record all symptoms and details of angioedema attacks, including on-demand treatments, as well as Patient Reported Outcomes (PROs). Participants need to have access to FDA approved on-demand angioedema medication and be able to treat any angioedema attack that may occur using standard of care on-demand therapies. In addition to the collected data on angioedema attacks, the diary will be used as a dosing diary for the daily intake of study drug treatment in Part 1.
Part 1 will evaluate the efficacy and safety of deucrictibant administered orally for prophylaxis against angioedema attacks in patients with BK-AE-nC1INH. After providing written informed consent, participants will be screened for eligibility. Eligible participants will be enrolled in the study. Participants receiving angioedema medications for long-term prophylaxis (LTP) will discontinue and washout these medications prior to Screening.
Dosing schedule: QD administration of study drug or placebo (double blind) throughout the Treatment Period consisting of deucrictibant (40 mg strength) XR tablet and matching placebo for oral use.
The duration of an individual's participation in Part 1 is up to 24 weeks (12 weeks on each deucrictibant and placebo, in random order).
Participants will be randomized in a 1:1 ratio to receive deucrictibant 40 mg XR tablet or matching placebo once daily (QD) each for 12 weeks and then participants will be crossed over, for a total of 24 weeks of treatment.
Part 2: After completion of Part 1, a study visit will be conducted at Week 24, at which the enrolled participants will be re-randomized in Part 2 on a 1:1 ratio to a treatment sequence to receive deucrictibant 20 mg soft capsule following by matching placebo or vice versa, with one capsule given for each of 2 attacks. Participants will self-administer blinded study drug in the assigned treatment sequence at home to treat 2 non-laryngeal qualifying angioedema attacks (at least one attack symptom [skin pain, skin swelling, or abdominal pain] has reached the individual item score of ≥20 in VAS-3). The time of administration of study drug as well as rescue medication must be recorded in the patient diary.The expected duration of Part 2 is up to 16 weeks.
End-of-Treatment and End-of-Study visits will occur within 7±2 days and 28 days (-14 days), respectively, after treatment of the second attack in Part 2.
Dosing schedule: Administration of study drug for acute angioedema attacks, dosing consists of deucrictibant (20 mg strength) soft capsule and matching placebo for oral use.
The duration of treatment in Part 2 is approximately 16 weeks.
Efficacy will be assessed based upon the occurrences of angioedema attacks, which will be confirmed by Investigators. During Screening, site personnel will discuss with participants the requirements for reporting angioedema attacks, including the information that is to be captured for each angioedema attack.
A Statistical Analysis Plan (SAP) will be finalized prior to database lock and will include a more technical and detailed description of all planned statistical analyses of all study endpoints.
The analysis of safety and tolerability will be performed on the Safety Analysis Set (ie, all randomized participants who have received at least 1 dose of study drug). Treatment-emergent AEs (TEAEs) are defined as AEs that start or pre-existing AEs that have worsened after the initiation of study drug.
The number and percentage of participants with TEAEs will be summarized by treatment group by body system organ class (SOC) and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA®). Clinical laboratory data, vital signs, physical examination, and ECG data will be presented in summary tables and individual listings by treatment group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Deucrictibant XR tablet, 40 mg, prophylaxis | Experimental | Drug: Deucrictibant XR tabletDeucrictibant XR tablet, 40 mg, QD, oral use for 12 weeks |
| Placebo to deucrictibant XR tablet, 40 mg, prophylaxis | Placebo comparator | Drug: Placebo comparator to XR tabletPlacebo tablets, 40 mg equivalent, QD, oral use for 12 weeks |
| On-demand deucrictibant 20 capsule, oral use | Experimental | Drug: Deucrictibant 20 mg capsuleSingle 20 capsule orally for treatment of on-demand angioedema attack, for up to 16 weeks |
| Placebo comparator to on-demand deucrictibant 20 capsule, oral use | Placebo comparator | Drug: Placebo comparator to 20 mg capsulePlacebo capsules for treatment of on-demand angioedema attacks, for up to 16 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- The "attack period" is defined as within 24 hours after an attack.
- Documented history of at least 2 angioedema attacks in the previous 2 months.
Key exclusion criteria (14 listed)
- 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:
- Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deucrictibant XR tabletAlso: Deucrictibant XRDeucrictibant 40 mg XR tablet for prophylaxis | Drug | Deucrictibant XR tablet, 40 mg, prophylaxis |
| Placebo comparator to XR tabletAlso: PlaceboPlacebo comparator to deucrictibant 40 mg XR tablet, prophylaxis | Drug | Placebo to deucrictibant XR tablet, 40 mg, prophylaxis |
| Deucrictibant 20 mg capsuleAlso: DeucrictibantDeucrictibant active drug for on-demand treatment of angioedma attacks | Drug | On-demand deucrictibant 20 capsule, oral use |
| Placebo comparator to 20 mg capsuleAlso: PlaceboPlacebo comparator to Deucrictibant 20 mg capsule for on-demand treatment of angioedema attacks | Drug | Placebo comparator to on-demand deucrictibant 20 capsule, oral use |
Primary outcome
Part-1: Incidence and quality of HAE attacks comparing active versus placebo arms.
Time frame: 24 weeks
Part-1: Time-normalized number of Investigator-confirmed moderate or severe angioedema attacks during the Treatment Period. Time-normalized number of Investigator-confirmed angioedema attacks treated with on-demand medication during the Treatment Period.
Part-2: Efficacy of active on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks
Time frame: 16 weeks
Part-2: Time to onset of symptom relief of active drug versus placebo, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
2 secondary outcomes
Safety assessment of oral deucrictibant extended release (XR) tablet (Part 1), and deucrictibant oral on-demand tablets (Part 2).
Time frame: 40 weeks
Part-1: Change in Health-Related Quality of Life (HRQoL) Scores Between Active Drug and Placebo Periods
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 22913638Weller K, Groffik A, Magerl M, Tohme N, Martus P, Krause K, Metz M, Staubach P, Maurer M. Development and construct validation of the angioedema quality of life questionnaire. Allergy. 2012 Oct;67(10):1289-98. doi: 10.1111/all.12007. Epub 2012 Aug 23.
- Background: PubMed 36720386Riedl MA, Danese M, Danese S, Ulloa J, Maetzel A, Audhya PK. Hereditary Angioedema With Normal C1 Inhibitor: US Survey of Prevalence and Provider Practice Patterns. J Allergy Clin Immunol Pract. 2023 Aug;11(8):2450-2456.e6. doi: 10.1016/j.jaip.2023.01.023. Epub 2023 Jan 30.
- Background: PubMed 22123383Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
- Individual participant dataSharing planned: Yes. Access to trial Individual Participant Data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA) at least 9 months after the publication date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deucrictibant XR tablet and Deucrictibant 20 mg capsule in people with Hereditary Angioedema (HAE) and Angioedema, run by Institute for Asthma and Allergy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Li, MD (301-962-5800, info@allergyasthma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part-1: Incidence and quality of HAE attacks comparing active versus placebo arms. (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07046806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.