Part 2: Open-label for Hereditary Angioedema Type I

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hereditary Angioedema Type I+11 More
PHA-022121 high dose - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can prevent hereditary angioedema attacks. The study will have 30 patients and will last for 12 weeks.

Eligible Conditions
  • Hereditary Angioedema Type I
  • Angioedema
  • C1 Inhibitor Deficiency
  • Angioedemas, Hereditary
  • C1 Esterase Inhibitor Deficiency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hereditary Angioedema Type I

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Day 84 to Day 252

Day 84
Number and proportion of days with angioedema symptoms during the treatment period
Number of investigator-confirmed HAE attacks
Number of investigator-confirmed HAE attacks requiring acute treatment during the treatment period
Number of investigator-confirmed HAE attacks resulting in a visit to the emergency department or an admission to hospital
Number of investigator-confirmed moderate or severe HAE attacks during the treatment period
Number of patients achieving reduction in attack rate during the treatment period relative to baseline
Number of patients that are attack-free during the treatment period
Time to first investigator-confirmed HAE attack in the treatment period
Day 252
Therapeutic procedure
Number and proportion of days with angioedema symptoms during the treatment period in Part 2.
Angioedema
Angioedema
Number of investigator-confirmed moderate or severe angioedema attacks during the treatment period in Part 2.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hereditary Angioedema Type I

Trial Design

4 Treatment Groups

Part 2: Open-label
1 of 4
Part 1: Low dose
1 of 4
Part 1: High dose
1 of 4
Part 1: Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

30 Total Participants · 4 Treatment Groups

Primary Treatment: Part 2: Open-label · Has Placebo Group · Phase 2

Part 2: Open-label
Drug
Experimental Group · 1 Intervention: PHA-022121 high dose · Intervention Types: Drug
Part 1: Low dose
Drug
Experimental Group · 1 Intervention: PHA-022121 low dose · Intervention Types: Drug
Part 1: High dose
Drug
Experimental Group · 1 Intervention: PHA-022121 high dose · Intervention Types: Drug
Part 1: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 84 to day 252

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor
2 Previous Clinical Trials
146 Total Patients Enrolled
2 Trials studying Hereditary Angioedema Type I
146 Patients Enrolled for Hereditary Angioedema Type I
Marc Riedl, MDPrincipal InvestigatorUC San Diego, La Jolla, California, United States
Emel Aygören-Pürsün, MDPrincipal InvestigatorUniversity Hospital Frankfurt - Goethe University, Frankfurt, Germany
1 Previous Clinical Trials
75 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have reliable access to the standard of care acute attack medications.
Documented history of at least 3 HAE attacks within the last 3 consecutive months prior to screening, or a minimum of 2 HAE attacks during the screening period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.