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Small Molecule

Deucrictibant for Hereditary Angioedema (RAPIDe-2 Trial)

Phase 2 & 3
Recruiting
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
Diagnosis of HAE type I or II
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through study completion, up to 40 months (dependent on time of enrollment).
Awards & highlights

RAPIDe-2 Trial Summary

This trial will study the long-term effects of a drug for hereditary angioedema, a condition where people have swellings in different parts of the body.

Who is the study for?
This trial is for patients with Hereditary Angioedema (HAE) due to C1-INH deficiency who have taken at least one dose of the study drug in a previous related trial. Participants must not be pregnant, breastfeeding, or have any condition that could affect their safety or participation. They also shouldn't be on certain other HAE treatments or drugs affecting liver enzymes.Check my eligibility
What is being tested?
The study tests long-term use of deucrictibant at various doses for treating sudden HAE attacks. It's an extension from a prior study and focuses on oral administration effectiveness and safety over time, including its impact on severe throat swelling attacks.See study design
What are the potential side effects?
While specific side effects are not listed here, common concerns may include potential reactions to the medication such as stomach issues, headaches, dizziness, or allergic reactions. Long-term safety will be closely monitored throughout the trial.

RAPIDe-2 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.

RAPIDe-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through study completion, up to 40 months (dependent on time of enrollment).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment through study completion, up to 40 months (dependent on time of enrollment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure
Body temperature
Heart Rate
+1 more
Secondary outcome measures
Change in Mean symptom complex severity (MSCS) score
Change of VAS-3 score and individual VAS score from pre-treatment to 4 h post-treatment for non-laryngeal attacks
Proportion of PHA-022121-treated attacks requiring a second dose of PHA-022121
+6 more

RAPIDe-2 Trial Design

4Treatment groups
Experimental Treatment
Group I: Part B: Selected doseExperimental Treatment1 Intervention
Single dose of deucrictibant
Group II: Part A: Medium doseExperimental Treatment1 Intervention
Single medium dose of deucrictibant
Group III: Part A: Low doseExperimental Treatment1 Intervention
Single low dose of deucrictibant
Group IV: Part A: High doseExperimental Treatment1 Intervention
Single high dose of deucrictibant

Find a Location

Who is running the clinical trial?

Pharvaris Netherlands B.V.Lead Sponsor
4 Previous Clinical Trials
254 Total Patients Enrolled
Marcus Maurer, Prof MDPrincipal InvestigatorCharite University, Berlin, Germany
1 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

PHA-022121 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT05396105 — Phase 2 & 3
Hereditary Angioedema Research Study Groups: Part A: Medium dose, Part A: High dose, Part A: Low dose, Part B: Selected dose
Hereditary Angioedema Clinical Trial 2023: PHA-022121 Highlights & Side Effects. Trial Name: NCT05396105 — Phase 2 & 3
PHA-022121 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05396105 — Phase 2 & 3

Frequently Asked Questions

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

Are new test subjects needed for this experiment?

"This clinical trial is actively looking for patients, with the original posting on July 19th, 2022 and the most recent update on October 25th, 2022."

Answered by AI

Who else is applying?

What site did they apply to?
Study site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Medical personnel lacking informstion on this particular occurance. Need help now.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
2022. "Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05396105.
All > Hereditary Angioedema
~22 spots leftby Dec 2024
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