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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84 to day 938

Awards & highlights

HAE CHAPTER-1 Trial 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.Check my eligibility

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.See study design

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.

HAE CHAPTER-1 Trial 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.

HAE CHAPTER-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84 to day 938

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84 to day 938

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 to day 938 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of investigator-confirmed HAE attacks

Secondary outcome measures

Therapeutic procedure

Number and proportion of days with angioedema symptoms during the treatment period

Number and proportion of days with angioedema symptoms during the treatment period in Part 2.

+9 more

HAE CHAPTER-1 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor

4 Previous Clinical Trials

292 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research endeavor?

"Correct. Clinicaltrials.gov records demonstrate that this examination, initially posted on April 19th 2022, is currently enlisting participants. 30 patients should be recruited from 5 distinct clinical sites."

Answered by AI

May I enroll in this experiment?

"To qualify for this research project, individuals must possess the genetic disorder hereditary angioedema type I and be between 18-75 years old. The target enrollment is 30 people."

Answered by AI

Is enrollment for this research initiative still available?

"The publically accessible clinicaltrials.gov website confirms that this medical trial is still in the process of recruiting participants - since its initial posting on April 19th 2022, it has been updated as recently as October 25th 2022."

Answered by AI

In what areas is this research project currently taking place?

"Presently, this research project is looking for participants from 5 different sites. Ottawa, Montréal and North York are a few of these locations, with the remaining locales being distributed elsewhere. It's important to choose the medical centre nearest you in order to minimize travel requirements when participating."

Answered by AI

Does the study accept participants aged 40 and above?

"The eligibility requirements for this trial specify that applicants must fall within the 18 to 75 age range. For minors and seniors, there are 12 studies tailored to those below 18 years old and 19 specifically catered towards individuals over 65."

Answered by AI

Has Part 2: Open-label been authorized by the FDA?

"As this trial is only in Phase 2, there is existing evidence of safety, but none to support efficacy. Thus our team at Power has rated the safety of Part 2: Open-label a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

2022. "Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05047185.

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