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Oral PHA-022121 for Hereditary Angioedema (HAE CHAPTER-1 Trial)

Phase 2
Waitlist Available
Led By Marc Riedl, MD
Research Sponsored by Pharvaris Netherlands B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of HAE type I or II
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
Must not have
Abnormal renal function
Abnormal hepatic function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

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.

Who is the study for?
This trial is for people with Hereditary Angioedema (HAE) types I or II who've had at least 3 attacks in the last 3 months, or a minimum of 2 during screening. They must be able to use standard acute attack meds and sign consent forms. It's not for pregnant/breastfeeding individuals, those with significant health issues that could affect safety/participation, recent drug abuse history, abnormal kidney/liver function, or if they've used certain HAE treatments/drugs recently.
What is being tested?
The study tests PHA-022121 taken orally to prevent angioedema attacks in HAE patients. It has two parts: Part 1 randomly assigns patients to low/high doses of the drug or placebo for 12 weeks; all move to Part 2 afterwards for an open-label extension lasting up to 30 months.
What are the potential side effects?
While specific side effects are not listed here, common ones may include digestive discomforts like nausea or diarrhea, potential allergic reactions ranging from mild rashes to more severe responses depending on individual tolerance towards new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Hereditary Angioedema type I or II.
Select...
I have had at least 3 HAE attacks in the last 3 months or 2 during screening.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is not normal.
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My liver isn't working properly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Open-labelExperimental Treatment1 Intervention
BID high dose of deucrictibant
Group II: Part 1: Low doseExperimental Treatment1 Intervention
BID low dose of deucrictibant
Group III: Part 1: High doseExperimental Treatment1 Intervention
BID high dose of deucrictibant
Group IV: Part 1: PlaceboPlacebo Group1 Intervention
BID placebo

Find a Location

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor
6 Previous Clinical Trials
571 Total Patients Enrolled
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

Media Library

PHA-022121 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05047185 — Phase 2
Hereditary Angioedema Research Study Groups: Part 1: Low dose, Part 1: High dose, Part 1: Placebo, Part 2: Open-label
Hereditary Angioedema Clinical Trial 2023: PHA-022121 Highlights & Side Effects. Trial Name: NCT05047185 — Phase 2
PHA-022121 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05047185 — Phase 2
~5 spots leftby Jun 2025
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