81 Participants Needed

Deucrictibant for Angioedema

(CHAPTER-3 Trial)

Recruiting at 19 trial locations
PC
Overseen ByPharvaris Clinical Team
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use ACE inhibitors, estrogen-containing medications, or certain HAE treatments close to the screening period. Check with the trial team to see if your current medications are affected.

What data supports the effectiveness of the drug Deucrictibant for treating angioedema?

Research on a similar drug, Icatibant, shows it effectively reduces the time to resolve angioedema attacks, especially those related to certain blood pressure medications, from about 2 days to 10 hours. This suggests that drugs targeting bradykinin (a protein involved in inflammation) can be effective for angioedema.12345

What is the purpose of this trial?

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of once-daily orally administered deucrictibant extended-release tablet compared to placebo for prophylaxis to prevent angioedema attacks in participants aged ≥ 12 years with hereditary angioedema.

Research Team

SD

Study Director, Pharvaris

Principal Investigator

Pharvaris Netherlands B.V.

Eligibility Criteria

This trial is for adolescents and adults aged 12 years or older with hereditary angioedema (HAE), who have had at least three HAE attacks in the past three months. Participants must be able to manage acute HAE attacks, follow protocol requirements, and use contraception if applicable.

Inclusion Criteria

Provision of written informed consent/assent
Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording
I can get and use the needed medicine for sudden HAE attacks.
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Exclusion Criteria

I am not pregnant, planning to become pregnant, or breast-feeding.
Known hypersensitivity to deucrictibant or any of the excipients of the study drug
I don't have any health issues that would make it unsafe for me to join the study.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-daily orally administered deucrictibant extended-release tablet or placebo for 24 weeks

24 weeks
Regular visits for efficacy and safety assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may roll over into the open-label study PHA022121-C307 (CHAPTER-4)

Treatment Details

Interventions

  • Deucrictibant
Trial Overview The study tests a once-daily oral deucrictibant extended-release tablet against a placebo to prevent angioedema attacks. It's a Phase 3 trial where participants are randomly assigned to either the medication or placebo without knowing which one they receive.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Placebo 1 tablet by mouth once daily
Group II: ActiveExperimental Treatment1 Intervention
Deucrictibant 40mg extended-release tablet by mouth once daily

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pharvaris Netherlands B.V.

Lead Sponsor

Trials
7
Recruited
610+

Findings from Research

In a randomized trial involving patients with ACE-inhibitor-induced angioedema, icatibant was found to be effective in reducing symptoms, demonstrating its potential as a treatment option for this condition.
The study highlighted the safety profile of icatibant, showing that it was well-tolerated among participants, which is crucial for patients experiencing acute angioedema episodes.
Icatibant Compared to Steroids and Antihistamines for ACE-Inhibitor-Induced Angioedema.Botnaru, T., Robert, A., Mottillo, S.[2017]
In a study involving 18 patients treated with C1-inhibitor concentrate for acute hereditary angioedema (HAE) attacks, most reported health-related quality of life (HRQoL) scores within a normal range, indicating effective management of their condition.
Over 50% of participants felt that the availability of C1-INH significantly improved their well-being, with more than 80% expressing a better outlook on their future and increased security regarding the risk of life-threatening attacks.
C1-inhibitor therapy for hereditary angioedema attacks: prospective patient assessments of health-related quality of life.Bewtra, AK., Levy, RJ., Jacobson, KW., et al.[2016]
In a study of 685 patients with hereditary angioedema (HAE-C1-INH), German patients experienced significantly fewer severe attacks (38.7%) compared to patients from other countries (57.5%), indicating better management of the condition.
German patients also had better treatment outcomes with icatibant, showing shorter times to treatment (0.0 hours vs. 1.5 hours) and resolution (3.0 hours vs. 7.0 hours), suggesting that earlier intervention may lead to improved results.
Management of patients with hereditary angioedema in Germany: comparison with other countries in the Icatibant Outcome Survey.Maurer, M., Bork, K., Martinez-Saguer, I., et al.[2020]

References

Icatibant Compared to Steroids and Antihistamines for ACE-Inhibitor-Induced Angioedema. [2017]
C1-inhibitor therapy for hereditary angioedema attacks: prospective patient assessments of health-related quality of life. [2016]
Management of patients with hereditary angioedema in Germany: comparison with other countries in the Icatibant Outcome Survey. [2020]
Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. [2015]
Icatibant: a novel approach to the treatment of angioedema related to the use of angiotensin-converting enzyme inhibitors. [2014]
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