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Also known as PHVS416, PHA121, PHA-022121
Deucrictibant · 6 trials · 18 indications
Blood samples will be collected for the analysis of hematology parameters.
Blood samples will be collected for the analysis of clinical chemistry parameters.
Urine samples will be collected for the analysis of urinalysis parameters.
Digital triplicate 12-lead ECG. Descriptive in nature, no formal statistical hypothesis testing will be performed.
The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
Descriptive in nature, no formal statistical hypothesis testing will be performed.
Systolic and diastolic blood pressure will be measured. Descriptive in nature, no formal statistical hypothesis testing will be performed.
Descriptive in nature, no formal statistical hypothesis testing will be performed.
hematology, blood chemistry, urinalysis
The primary endpoint of the study was the change of the VAS-3 (3-symptom composite visual analogue scale) score from pre-treatment to 4 hours post-treatment. The VAS-3 was calculated as the mean of the VAS scores of the 3 major HAE symptoms: skin swelling, skin pain, and abdominal pain. The VAS scores of the 3 major HAE symptoms (skin swelling, skin pain, and abdominal pain) could range between 0 (No swelling/No pain) and 100 (Extreme swelling/Excruciating pain)
| Arm | Type | Description |
|---|---|---|
| Part 1 - Arm 1 - Active | EXPERIMENTAL | - |
| Part 1 - Arm 2 - Placebo | PLACEBO_COMPARATOR | - |
| Part 2 - Arm 1 | EXPERIMENTAL | - |
| Part 2 - Arm 2 | EXPERIMENTAL | - |
| Part 3 - Open-label | EXPERIMENTAL | - |
| Deucrictibant | EXPERIMENTAL | Deucrictibant |
| Active | EXPERIMENTAL | Deucrictibant 40mg extended-release tablet by mouth once daily |
| Placebo | EXPERIMENTAL | Placebo 1 tablet by mouth once daily |
| Arm 1 | EXPERIMENTAL | Deucrictibant administered for first HAE attack, placebo administered for second HAE attack. |
| Arm 2 | EXPERIMENTAL | Placebo administered for first HAE attack, deucrictibant administered for second HAE attack. |
| Part A: Deucrictibant, blinded dose | EXPERIMENTAL | Participants will receive the dose of deucrictibant they were randomized to in the PHA022121-C201 study (low, medium, or high dose, each consisting of 3 capsules of deucrictibant or matching placebo) for oral use for on-demand treatment of HAE attacks. |
| Part B: Deucrictibant, open-label | EXPERIMENTAL | Participants will receive deucrictibant soft capsules for oral use for on-demand treatment of HAE attacks. |
| Low dose/placebo | OTHER | Single low dose of deucrictibant or placebo |
| Medium dose/placebo | OTHER | Single medium dose of deucrictibant or placebo |
| High dose/placebo | OTHER | Single high dose of deucrictibant or placebo |
| Name | Type | Description |
|---|---|---|
| Deucrictibant | DRUG | Part 1: Deucrictibant 40 mg extended-release tablet for once daily oral use |
| Placebo | DRUG | Part 1: Placebo Comparator tablet for once daily oral use |
| Deucrictibant, Placebo | DRUG | Deucrictibant Soft Capsules for Oral Use |
Inclusion Criteria: * Provision of written informed consent * Male or female (sex at birth) aged ≥18 years * Diagnosis of AAE-C1INH * History of AAE-C1INH attacks prior to the Screening Visit. * If underlying disease associated with AAE is present, the underlying disease must be stable throughout t...
Deucrictibant is an investigational oral medicine being developed for hereditary angioedema and for acquired angioedema due to C1-inhibitor deficiency. It is being studied both as on-demand treatment of angioedema attacks and as prophylaxis against attacks in adolescents and adults. Pharvaris N.V. is developing it, and it remains in clinical development.
Deucrictibant targets bradykinin, the peptide mediator that drives swelling attacks in angioedema. By acting on bradykinin signaling, the small molecule is designed to reduce attack frequency when used prophylactically and to treat attacks when used on demand. It is an oral small molecule rather than an injectable therapy.
Deucrictibant is developed by Pharvaris N.V., a biopharmaceutical company whose shares trade under the ticker PHVS. Pharvaris is running the clinical program across hereditary angioedema and acquired angioedema due to C1-inhibitor deficiency. The drug has received an orphan drug designation from the FDA.
Deucrictibant is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes five trials in total, three of which are active, and the studies are randomized, double-blind, and placebo-controlled. Pharvaris is developing both an extended-release tablet for prophylaxis and a soft capsule for on-demand treatment.
Phase 3 trials include NCT07266805 in acquired angioedema due to C1-inhibitor deficiency, NCT06679881 and NCT06669754 in hereditary angioedema prophylaxis, and the completed NCT06343779 in on-demand treatment of hereditary angioedema attacks. Across the program, 609 participants have been enrolled, with trials running in North America, Europe, Asia, Latin America, and Oceania.
Deucrictibant is not approved and remains an investigational therapy in Phase 3 development for hereditary angioedema and acquired angioedema due to C1-inhibitor deficiency. Pharvaris is studying an extended-release tablet for prophylaxis against attacks and a soft capsule for on-demand treatment of attacks. The FDA has granted the program orphan drug designation.