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Bradykinin Receptor Antagonist
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.
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.
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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Who is running the clinical trial?
Pharvaris Netherlands B.V.Lead Sponsor
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Study Director, PharvarisStudy DirectorPharvaris Netherlands B.V.
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