Deucrictibant for Hereditary Angioedema (RAPIDe-2 Trial)

Phase 2 & 3

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

Diagnosis of HAE type I or II

Must not have

Use of concomitant medications that are potent CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) or potent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment through study completion, up to 54 months (dependent on time of enrollment).

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking strong medications that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment through study completion, up to 54 months (dependent on time of enrollment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment through study completion, up to 54 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 54 months (dependent on time of enrollment). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Blood pressure

Body temperature

Clinical laboratory tests

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Secondary study objectives

Proportion of deucrictibant-treated attacks with almost complete or complete symptom relief by VAS-3/ VAS-5/ AMRA through 24 hours post-treatment

Time to onset of symptom relief by VAS-3/VAS-5 (Part A) or AMRA (Part B), defined as a reduction of ≥30% from pretreatment in VAS/AMRA composite score, sustained for 2 consecutive timepoints)

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

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