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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04618211
Other study ID # PHA022121-C201
Secondary ID 2020-003445-11
Status Completed
Phase Phase 2
First received
Last updated
Start date February 3, 2021
Est. completion date March 1, 2023

Study information

Verified date June 2023
Source Pharvaris Netherlands B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In Part I of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. In Part II of the study, patients self-administer blinded study drug at home to treat three HAE attacks with deucrictibant or placebo (cross-over).


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date March 1, 2023
Est. primary completion date September 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Key Inclusion Criteria: 1. Signed and dated informed consent form 2. Diagnosis of HAE type I or II 3. 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 4. Reliable access and experience to use standard of care acute attack medications Key Exclusion Criteria: 1. Pregnancy or breast-feeding 2. Clinically significant abnormal electrocardiogram 3. Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study 4. Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment 5. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus 6. Abnormal hepatic function 7. Abnormal renal function 8. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse 9. History of documented severe hypersensitivity to any medicinal product 10. Participation in any other investigational drug study within defined period

Study Design


Intervention

Drug:
Deucrictibant
deucrictibant soft capsules for oral use
Placebo
Matching placebo capsules for oral use

Locations

Country Name City State
Bulgaria Study site Sofia
Canada Study site Edmonton Alberta
Canada Study site Montréal Quebec
Canada Study site Ottawa Ontario
Canada Study site Québec City Quebec
Canada Study site Toronto Ontario
Czechia Study site Brno
Czechia Study site Hradec Králové
France Study site Grenoble
France Study site Montpellier
France Study site Paris
Germany Study site Berlin
Germany Study site Dresden
Germany Study site Frankfurt
Germany Study site Mainz
Germany Study site Ulm
Hungary Study site Budapest
Israel Study site Ashkelon
Israel Study site Haifa
Israel Study site Tel Aviv
Italy Study site Monserrato
Italy Study site Naples
Netherlands Study site Amsterdam
Poland Study site Kraków
Spain Study site Barcelona
Spain Study site Madrid
United Kingdom Study site Brighton
United Kingdom Study site London
United States Study site Birmingham Alabama
United States Study site Chevy Chase Maryland
United States Study site Hershey Pennsylvania
United States Study site Paradise Valley Arizona
United States Study site Saint Louis Missouri
United States Study site San Diego California
United States Study site Santa Monica California
United States Study site Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Pharvaris Netherlands B.V.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of the 3-symptom composite visual analogue scale (VAS-3) score from pre-treatment to 4 hours post-treatment VAS-3 scores range between 0 and 100. A larger reduction means a better outcome. Pre-treatment and 4 hours post-treatment
Secondary Time to onset of symptom relief by visual analogue scale (VAS-3) score VAS-3 scores range between 0 and 100. Symptom relief is defined as a 50% or higher reduction of the VAS-3 score from the pre-treatment value. Assessed from pre-treatment to 48 hours post-treatment
Secondary Proportion of study drug treated attacks requiring HAE rescue medication Qualifying attacks treated with study drug may use approved rescue medication if no symptom relief within 4 h has been experienced. Assessed at 4 hours post-study drug treatment
Secondary Time to onset of almost complete and complete symptom relief by visual analogue scale (VAS-3) VAS scores range between 0 and 100. Almost complete symptom relief is defined as all 3 individual VAS scores of the VAS-3 having a value < 10. Complete symptom relief is defined as all 3 individual VAS scores are of the VAS-3 having a value of 0. Assessed from pre-treatment to 48 hours post-treatment
Secondary Mean symptom complex severity (MSCS) score MSCS scores range between 0 and 3. A higher score means a worse outcome. 4 hours post-treatment
Secondary Treatment outcome score (TOS) TOS scores range between -100 and 100. A positive score indicates improvement, a score of 0 indicates no change, and a negative score indicates worsening compared to pre-treatment. Pre-treatment and 4 hours post-treatment
Secondary Treatment satisfaction questionnaire for medication (TSQM) scores TSQM scores range from 0 to 100. A higher score means a better outcome. 48 hours post-treatment
Secondary Treatment-emergent adverse events (TEAEs) From post-dose non-attack visit through study completion, approximately 26 weeks
Secondary Treatment-related adverse events (AEs) From post-dose non-attack visit through study completion, approximately 26 weeks
Secondary Treatment-emergent serious adverse events (TESAEs) From post-dose non-attack visit through study completion, approximately 26 weeks
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