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Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema (RAPIDe-1 Trial)

Phase 2
Waitlist Available
Led By Marcus Maurer, Prof 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours post-treatment

Summary

This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of deucrictibant and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of deucrictibant with placebo.

Eligible Conditions
  • Hereditary Angioedema
  • Angioedema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Change of the 3-symptom composite visual analogue scale (VAS-3) score from pre-treatment to 4 hours post-treatment
Secondary study objectives
Mean symptom complex severity (MSCS) score
Proportion of study drug treated attacks requiring HAE rescue medication
Time to onset of almost complete and complete symptom relief by visual analogue scale (VAS-3)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Medium dose/placeboExperimental Treatment2 Interventions
Single medium dose of deucrictibant or placebo
Group II: Low dose/placeboExperimental Treatment2 Interventions
Single low dose of deucrictibant or placebo
Group III: High dose/placeboExperimental Treatment2 Interventions
Single high dose of deucrictibant or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucrictibant
2021
Completed Phase 2
~80
Placebo
1995
Completed Phase 3
~2670

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Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor
6 Previous Clinical Trials
531 Total Patients Enrolled
Marcus Maurer, Prof MDPrincipal InvestigatorCharite University, Berlin, Germany
1 Previous Clinical Trials
140 Total Patients Enrolled
~15 spots leftby Dec 2025
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