Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pharvaris Netherlands B.V.
Study ID
NCT05396105
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • C1 Esterase Inhibitor Deficiency
  • C1 Esterase Inhibitor [C1-INH] Deficiency
  • C1 Esterase Inhibitor, Deficiency of
  • C1 Inhibitor Deficiency
  • Hereditary Angioedema
  • Hereditary Angioedema (HAE)
  • Hereditary Angioedema - Type 1
  • Hereditary Angioedema - Type 2
  • Hereditary Angioedema - Type 3
  • Hereditary Angioedema Attack
  • Hereditary Angioedema Type I
  • Hereditary Angioedema Type I and II
  • Hereditary Angioedema Type II
  • Hereditary Angioedema Type III
  • Hereditary Angioedema Types I and II
  • Hereditary Angioedema With C1 Esterase Inhibitor Deficiency

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • deucrictibant — DRUG
    3 capsules of deucrictibant or matching placebo will be administered orally for each HAE attack
  • deucrictibant — DRUG
    deucrictibant soft capsules will be administered orally for each HAE attack

Study Details

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks. The study will enroll participants from Study PHA022121-C201 (NCT04618211), Study PHA022121-C306 (NCT06343779) and deucrictibant treatment naïve HAE-nC1INH adult participants who elect to participate in this extension study and meet the eligibility requirements.

Key Dates

Start date
Dec 28, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Deucrictibant, blinded dose
    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.
  • Experimental: Part B: Deucrictibant, open-label
    Participants will receive deucrictibant soft capsules for oral use for on-demand treatment of HAE attacks.

Primary Outcome Measure

Treatment-emergent Adverse Events (TEAEs), treatment-related TEAEs, treatment-emergent serious adverse events (TESAEs), treatment-related TESAEs, and TEAEs leading to deucrictibant discontinuation [ Time Frame: From enrollment through study completion, up to 54 months (dependent on time of enrollment). ]

Locations (13)

FacilityCityStateZIPSite coordinators
Study siteBirminghamAlabama35209-
Study siteScottsdaleArizona85258-
Study siteLittle RockArkansas72205-
Study siteSan DiegoCalifornia92122-
Study siteSanta MonicaCalifornia90404-
Study siteWalnut CreekCalifornia94598-
Study siteColorado SpringsColorado80907-
Study siteChevy ChaseMaryland20815-
Study siteBostonMassachusetts02115-
Study siteDetroitMichigan48202-
Study siteSt LouisMissouri63141-
Study siteHersheyPennsylvania17033-
Study siteDallasTexas75231-

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