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Bradykinin Receptor Antagonist

Arm 1 for Hereditary Angioedema (RAPIDe-3 Trial)

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment to 48 hours post-treatment.

Awards & highlights

RAPIDe-3 Trial Summary

"This trial will test a new medication called deucrictibant compared to a placebo for treating HAE attacks in participants aged 12 to 75 with HAE type 1 or type

Who is the study for?

This trial is for adolescents and adults aged 12 to 75 with Hereditary Angioedema (HAE) types 1 or 2. It's suitable for those who experience HAE attacks, including non-severe throat swelling, and some may be on long-term prevention meds.Check my eligibility

What is being tested?

The study tests Deucrictibant soft capsules against a placebo when an HAE attack occurs. It's a Phase 3 trial where participants are randomly assigned to receive either the real drug or placebo in different periods without knowing which one they're taking.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones from similar treatments include reactions at the administration site, headaches, nausea, and potential allergic responses.

RAPIDe-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment to 48 hours post-treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment to 48 hours post-treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment to 48 hours post-treatment. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.

Secondary outcome measures

Proportion of attacks achieving symptom resolution.

Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment.

Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA.

+8 more

RAPIDe-3 Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

Placebo administered for first HAE attack, deucrictibant administered for second HAE attack.

Group II: Arm 1Experimental Treatment1 Intervention

Deucrictibant administered for first HAE attack, placebo administered for second HAE attack.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor

4 Previous Clinical Trials

206 Total Patients Enrolled

Study Director, PharvarisStudy DirectorPharvaris Netherlands B.V.

Frequently Asked Questions

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

Has Arm 1 received official authorization from the FDA?

"According to our assessment at Power, Arm 1 has been rated a score of 3 on the safety scale. This rating is attributed to it being part of a Phase 3 trial where there are existing data indicating efficacy and robust evidence supporting its safety profile."

Answered by AI

Are prospective participants able to enroll in this research study at the present time?

"As detailed on clinicaltrials.gov, this investigation is presently seeking eligible participants. The trial was first made available on February 26th, 2024 and subsequently updated on March 26th of the same year."

Answered by AI

What is the upper limit of participants involved in this clinical study?

"Indeed, as per clinicaltrials.gov, this investigation is presently in search of suitable candidates. The trial was publicly announced on February 26th, 2024, with the most recent update made on March 26th, 2024. It aims to enroll a total of 120 participants across three distinct sites."

Answered by AI