Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema

Inclusion Criteria:

- Age above 18 years;

- Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);

- Current edema be in the cutaneous, abdominal and/or laryngeal areas;

- Current edema be moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria:

- Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);

- Participation in a clinical trial of another investigational medicinal product (IMP)
within the past month;

- Treatment with any pain medication since onset of the current edema attack;

- Treatment with replacement therapy, including C1-INH products, less than 3 days from
onset of the current edema attack;

- Treatment with ACE inhibitors;

- Evidence of severe, symptomatic coronary artery disease based on medical history or
screening examination;

- Serious concomitant illnesses that the physician considers to be a contraindication
for participation in the trial;

- Pregnancy and/or breast-feeding.