Deucrictibant for Acquired Angioedema

(CREAATE Trial)

Recruiting at 1 trial location

Overseen By Pharvaris Clinical Team

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pharvaris Netherlands B.V.

Must not be taking: CYP3A4 inhibitors, ACE inhibitors

Disqualifiers: Pregnancy, Renal impairment, Epilepsy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called deucrictibant for people with acquired angioedema, a condition causing sudden swelling. Participants will receive either the actual medicine or a placebo (a pill with no active drug) to evaluate the treatment's effectiveness in preventing and treating swelling attacks. The trial includes several stages, some where participants know they are receiving the treatment, and some where they do not. It seeks individuals who have experienced angioedema attacks and can manage their condition with current treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are moderate or strong inhibitors or inducers of CYP3A4, or if they are angiotensin-converting enzyme inhibitors or estrogen-containing medications. The trial does not specify a washout period, but these medications should not be used within 30 days or 5 half-lives before the screening.

Is there any evidence suggesting that deucrictibant is likely to be safe for humans?

Previous studies have shown that deucrictibant is very safe. Safety checks included physical exams, lab tests, and heart monitoring, all of which confirmed that deucrictibant was well-tolerated. Additionally, past patients did not experience serious side effects or recurring symptoms after treatment. Deucrictibant has also been used in open-label studies, further supporting its long-term safety. Overall, research indicates that deucrictibant is safe for people with angioedema. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for angioedema?

Deucrictibant is unique because it offers a fresh approach to treating acquired angioedema by targeting the bradykinin pathway. Most current treatments, like C1 inhibitors and antihistamines, focus on different pathways or managing symptoms after an attack has started. Deucrictibant aims to prevent attacks before they even begin, which could significantly improve the quality of life for patients. Researchers are excited about this because it has the potential to provide faster and more effective relief compared to existing therapies.

What evidence suggests that deucrictibant might be an effective treatment for angioedema?

Previous studies have shown that deucrictibant holds promise in treating angioedema attacks. One study found that the average time for symptom relief was just 1.28 hours, much faster than with a placebo. Deucrictibant also effectively prevented attacks, maintaining a low number of hereditary angioedema (HAE) attacks for up to 34 months with daily use. Additionally, 83% of attacks were successfully treated with just one capsule of the on-demand version. This trial will evaluate deucrictibant's effectiveness in both preventing and quickly relieving angioedema attacks. ^{1 2 6 7 8}

Who Is on the Research Team?

Study Director, Pharvaris

Principal Investigator

Pharvaris Netherlands B.V.

Are You a Good Fit for This Trial?

Adults aged 18 or older with Acquired Angioedema due to C1 Inhibitor Deficiency (AAE-C1INH) can join this study. The trial is designed for those who need both preventive treatment and on-demand therapy for sudden angioedema attacks.

Inclusion Criteria

I have been diagnosed with AAE-C1INH.

History of AAE-C1INH attacks prior to the Screening Visit

Provision of written informed consent

Exclusion Criteria

Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer)

I am taking ACE inhibitors or estrogen medications.

My kidneys do not work well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1 Prophylaxis Double-blind Treatment

Participants receive blinded study drug (deucrictibant 40 mg XR or placebo) for prophylaxis in a 1:1 ratio

12 weeks

Part 2 On-demand Double-blind Treatment

Participants receive blinded study drug (deucrictibant 20 mg IR capsule or placebo) for 2 qualifying AAE-C1INH attacks in a 2-period, 2-treatment crossover design

Duration not specified

Part 3 On-demand Open-label Extension

All AAE-C1INH attacks are treated with open-label deucrictibant 20 mg soft capsule

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deucrictibant

Trial Overview The trial tests a new oral medication, Deucrictibant XR tablet, as a daily preventative measure against angioedema, and an immediate-release capsule form of the same drug for quick relief during acute attacks. It's compared to a placebo in a double-blind setup before moving to open-label use.

How Is the Trial Designed?

Group I: Part 3 - Open-label Experimental Treatment 1 Intervention

Group II: Part 2 - Arm 2 Experimental Treatment 2 Interventions

Group III: Part 2 - Arm 1 Experimental Treatment 2 Interventions

Group IV: Part 1 - Arm 1 - Active Experimental Treatment 1 Intervention

Group V: Part 1 - Arm 2 - Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pharvaris Netherlands B.V.

Lead Sponsor

Trials

7

Recruited

610+

Citations

1. ir.pharvaris.com ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-positive-topline-data-rapide-3-pivotal-study

Pharvaris Announces Positive Topline Data from RAPIDe-3 ... Primary endpoint met; median time to onset of symptom relief achieved in 1.28 hours, significantly faster versus placebo (p<0.0001) ...

2. healio.com healio.com/news/allergy-asthma/20251205/daily-deucrictibant-keeps-hereditary-angioedema-attack-rate-low-for-up-to-34-months

Daily deucrictibant keeps HAE attack rate low for up to 34 ... ORLANDO — Decreases in hereditary angioedema attack rates seen with daily oral deucrictibant at 13 weeks stayed at a low level for up to 34 ...

3. ir.pharvaris.com ir.pharvaris.com/news-releases/news-release-details/data-supporting-potentially-differentiated-pharvaris-portfolio

Data Supporting the Potentially Differentiated Pharvaris ... Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the ...

4. swissbiotech.org swissbiotech.org/listing/pharvaris-announces-positive-topline-data-from-rapide-3-pivotal-study-confirming-potential-of-deucrictibant-for-on-demand-treatment-of-hae-attacks-2/

Pharvaris: Positive pivotal study data for treatment of ... 83.0% of attacks were treated with a single capsule of deucrictibant IR · 93.2% of deucrictibant-treated attacks were treated without use of ...

5. finance.yahoo.com finance.yahoo.com/news/pharvaris-announces-positive-topline-data-115000109.html

Pharvaris Announces Positive Topline Data from RAPIDe-3 ... Primary endpoint met; median time to onset of symptom relief achieved in 1.28 hours, significantly faster versus placebo (p<0.0001).

6. jacionline.org jacionline.org/article/S0091-6749(24)00271-9/fulltext

Deucrictibant for angioedema due to acquired C1-inhibitor ... The safety data collected included physical examination findings, biochemistry analysis results, and electrocardiogram findings. The study ...

7. ir.pharvaris.com ir.pharvaris.com/news-releases/news-release-details/pharvaris-presents-data-supporting-ongoing-clinical-development

Pharvaris Presents Data Supporting Ongoing Clinical ... Deucrictibant data shows single-dose durability without symptom reoccurrence in the majority of HAE attacks treated; First-ever bradykinin ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07046806?term=AREA%5BInterventionSearch%5D(deucrictibant)&rank=4

Oral Deucrictibant for Prophylactic and Acute Treatment in ... Part 1 will evaluate the efficacy and safety of deucrictibant administered orally for prophylaxis against angioedema attacks in patients with BK-AE-nC1INH.