Deucrictibant 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

Pivotal 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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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