A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating The Safety And Efficacy Of Conestat Alfa As A Treatment For Angiotensin-Converting Enzyme-Inhibitor-Induced Angioedema
Posted Date: Jul 8, 2025
- Investigator: Andrew Adan
- Specialties: Allergy, Emergency Medicine
- Type of Study: Drug
This phase III clinical trial is being conducted to assess the benefits of emergency administration of intravenous (IV) conestat alfa to treat ACE-I-induced AE during an ED visit. This will be a multi-center, randomized, double-blind, two-armed, placebo-controlled trial. It will enroll 24 patients at two clinical sites in the United States. The population will consist of adult patients (= 18 years of age) who present to the ED with acute ACE-I-induced AE of the head and/or neck. Eligible patients will be enrolled in the study and randomized at a ratio of 1:1 to either the active treatment or placebo groups. The treatment group will receive intravenous conestat alfa at a dose of 50IU/kg based on weight up to <84kg a maximum dose of 4200 IU (International Units) for subjects =84kg IV along with usual ED care at the discretion of the clinical care team, which may include epinephrine, H1 and/or H2-antihistamines, and corticosteroids. The placebo group will receive the same volume of an isotonic, sterile, normal saline (pH 5.5 ± 0.3) solution without any preservatives via IV injection, in addition to the usual care. A second dose (50IU/kg dose based on weight <84kg and up to a maximum dose of 4200 IU for subjects =84kg) of open label study drug will be administered 2 hours after the initial dose as a rescue medication if the subject has not experienced symptom relief (based upon TOSR evaluation). Additional doses of study drug or placebo will not be used. The primary objective is to compare the Time to Onset of Symptom Relief (TOSR) of conestat alfa compared to placebo in the treatment of ACE-I-induced AE. The secondary objective is to evaluate the efficacy of conestat alfa compared to placebo in Time to Meeting Discharge Criteria (TMDC), based on investigator-assessment of upper airway symptoms. The study will also compare the proportion of patients in each arm who 1) are hospitalized for any level of care 2) are admitted to the intensive care unit (ICU) and 3) requiring airway intervention (e.g., intubation, cricothyrotomy, or tracheotomy). Safety and tolerability of conestat alfa treatment will also be assessed.
Criteria:
Null
Keywords:
Angioedema, Allergy, Ruconest
For More Information:
Andrew Adan
989-859-4942
adanaj@ucmail.uc.edu