Phase 2
N=74
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema · Hereditary Angioedema Type I · Hereditary Angioedema Type II · Hereditary Angioedema Types I and II · Hereditary Angioedema Attack
Bottom Line
View on ClinicalTrials.gov: NCT04618211 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment — -14.83; -13.10; -14.37; 1.92 Score on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Deucrictibant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharvaris Netherlands B.V.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of the 3-symptom Composite Visual Analogue Scale (VAS-3) Score From Pre-treatment to 4 Hours Post-treatment |
-14.83; -13.10; -14.37; 1.92 | < 0.0001 sig |
| SECONDARY Time to Onset of Symptom Relief by ≥30% Reduction in Visual Analogue Scale (VAS-3) Composite Score From the Pre-treatment Score |
2.1; 2.7; 2.5; 8.0 | < 0.0001 sig |
| SECONDARY Time to Onset of Almost Complete or Complete Symptom Relief by Visual Analogue Scale (VAS-3) |
5.8; 20.0; 20.0; 42.0 | < 0.0001 sig |
| SECONDARY Time to a ≥50% Reduction in VAS-3 Composite Score From the Pre-treatment Score |
3.3; 4.0; 4.0; 22.8 | < 0.0001 sig |
| SECONDARY Change in the Mean Symptom Complex Severity (MSCS) Score From Pre-treatment to 4 Hours Post-treatment |
-1.08; -0.91; -0.68; -0.29 | < 0.0001 sig |
| SECONDARY Treatment Outcome Score (TOS) at 4 Hours Post-treatment |
60.52; 59.08; 67.44; -3.62 | < 0.0001 sig |
| SECONDARY Time to Onset of Primary Symptom Relief Assessed by a 30% Reduction in the VAS for the Primary Symptom |
2.0; 3.0; 2.9; 23.3 | — |
| SECONDARY Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 12 Hours. |
7; 3; 2; 31 | — |
| SECONDARY Time to First HAE Rescue Medication Use for Study Drug-treated Attacks Within 48 Hours Post-treatment |
NA; NA; NA; 6.0 | — |
| SECONDARY Time to Change in the VAS Score for Skin Pain Score - 30% Reduction |
2.9; 3.4; 2.7; 22.8 | — |
| SECONDARY Change in Mean Symptom Complex Severity Score From Pre-treatment to 24 Hours Post-treatment |
-1.65; -1.50; -1.68; -1.20 | — |
| SECONDARY TOS at 24 Hours Post-treatment |
94.44; 93.60; 94.44; 76.92 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Effectiveness Domain Score |
79.17; 70.45; 72.92; 65.38 | — |
| SECONDARY Time to Onset of Primary Symptom Relief by 50% Reduction in VAS Score |
2.9; 4.5; 4.0; 22.8 | — |
| SECONDARY Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 24 Hours. |
37; 28; 31; 51; 9; 3 | — |
| SECONDARY Proportion of Study Drug Treated Attacks Requiring HAE Rescue Medication Within 48 Hours |
37; 28; 31; 51; 9; 4 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Convenience Domain Score |
80.56; 83.08; 77.55; 76.07 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication Scores at 48 Hours Post-treatment - Satisfaction Domain Score |
82.50; 80.68; 76.74; 64.10 | — |
| SECONDARY Time to Change in the VAS Score for Skin Swelling Score - 30% Reduction |
2.5; 3.5; 3.8; 23.3 | — |
| SECONDARY Time to Change in the VAS Score for Abdominal Pain Score - 30% Reduction |
1.9; 1.4; 2.9; 20.0 | — |
Summary
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.
Eligibility Criteria
Key Inclusion Criteria
- Signed and dated informed consent form
- Diagnosis of HAE type I or II
- Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening
- Reliable access and experience to use standard of care acute attack medications
Key Exclusion Criteria
- Pregnancy or breast-feeding
- Clinically significant abnormal electrocardiogram
- Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
- Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment
- Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus
- Abnormal hepatic function
- Abnormal renal function
- History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
- History of documented severe hypersensitivity to any medicinal product
- Participation in any other investigational drug study within defined period
Data sourced from ClinicalTrials.gov (NCT04618211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.