PHA-022121 selected dose for Angioedema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Study site, Walnut Creek, CA
Angioedema+13 More
PHA-022121 selected dose - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study the long-term effects of a drug for hereditary angioedema, a condition where people have swellings in different parts of the body. PHA-022121 will be used to treat Angioedema at the selected dose. This dose has been previously approved by the FDA for a different condition. There will be no placebo group in this trial.

Eligible Conditions

  • Angioedema
  • Hereditary Angioedema Type I
  • C1 Inhibitor Deficiency
  • C1 Esterase Inhibitor [C1-INH] Deficiency
  • C1 Esterase Inhibitor Deficiency
  • Angioedemas, Hereditary
  • C1 esterase inhibitor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: From enrollment through study completion, up to 40 months (dependent on time of enrollment).

48 hours post-treatment
Treatment satisfaction questionnaire for medication (TSQM) scores
Hour 4
Treatment outcome score (TOS)
Hour 48
Change in Mean symptom complex severity (MSCS) score
Time to almost complete or complete symptom relief (TACSR and TCSR) assessed by VAS-3 or VAS-5
Time to onset of symptom relief (TOSR) assessed by the 3- or 5-symptom visual analog scale score (VAS-3 or VAS-5)
Time to symptom improvement based on patient global impression of change (PGI-C)
Time to symptom improvement based on patient global impression of severity (PGI-S)
Month 40
Blood pressure
Body temperature
Heart Rate
Proportion of PHA-022121-treated attacks requiring a second dose of PHA-022121
Treatment-emergent Adverse Events (TEAEs), treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), and treatment-related TESAEs
Hour 4
Change of VAS-3 score and individual VAS score from pre-treatment to 4 h post-treatment for non-laryngeal attacks

Trial Safety

Safety Progress

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

Trial Design

4 Treatment Groups

Part A: Medium dose
1 of 4
Part A: High dose
1 of 4
Part A: Low dose
1 of 4
Part B: Selected dose
1 of 4
Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: PHA-022121 selected dose · No Placebo Group · Phase 2 & 3

Part A: Medium dose
Drug
Experimental Group · 1 Intervention: PHA-022121 medium dose · Intervention Types: Drug
Part A: High dose
Drug
Experimental Group · 1 Intervention: PHA-022121 high dose · Intervention Types: Drug
Part A: Low dose
Drug
Experimental Group · 1 Intervention: PHA-022121 low dose · Intervention Types: Drug
Part B: Selected dose
Drug
Experimental Group · 1 Intervention: PHA-022121 selected dose · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment through study completion, up to 40 months (dependent on time of enrollment).
Closest Location: Study site · Walnut Creek, CA
Photo of california 1Photo of california 2Photo of california 3
2012First Recorded Clinical Trial
3 TrialsResearching Angioedema
19 CompletedClinical Trials

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor
2 Previous Clinical Trials
104 Total Patients Enrolled
2 Trials studying Angioedema
104 Patients Enrolled for Angioedema
Marcus Maurer, Prof MDPrincipal InvestigatorCharite University, Berlin, Germany
1 Previous Clinical Trials
74 Total Patients Enrolled
1 Trials studying Angioedema
74 Patients Enrolled for Angioedema

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.